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Regulation 2(1)

[F1SCHEDULE 1N.I. ASSOCIATION AGREEMENTS

Textual Amendments

[F21.  The Agreement establishing an Association between the European Economic Community and Turkey signed at Ankara on 12th September 1963.]]N.I.

Textual Amendments

Regulation 2(1)

SCHEDULE 2N.I. MUTUAL RECOGNITION AGREEMENTS

Extent Information

E1This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only for the substitution of Sch. 2 in relation to E.W.S. (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(10) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

1.  The agreement on mutual recognition in relation to conformity assessment certificates and markings between the European Community and Australia, initialled on 19th July 1996 M1.N.I.

Marginal Citations

M1OJ No. L 229, 17.8.1998, p.3.

2.  The agreement on mutual recognition in relation to conformity assessment between the European Union and New Zealand, initialled on 19th July 1996 M2.N.I.

Marginal Citations

M2OJ No. L 229, 17.8.1998, p.62.

3.  The agreement on mutual recognition between the European Community and Canada, signed in London on 14th May 1998 M3.N.I.

Marginal Citations

M3OJ No. L 280, 16.10.1998, p.3.

4.  The agreement on mutual recognition between the European Community and the United States of America, signed in London on 18th May 1998 M4.N.I.

Marginal Citations

M4OJ No. L 31, 4.2.1999, p.3.

[F35.  The agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment signed in Luxembourg on 21st June 1999.]U.K.

Textual Amendments

Regulation 1A

[F4SCHEDULE 2E+W+SMutual Recognition Agreement countries

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Regulation 1A

[F5SCHEDULE 2AE+W+SModification of Annexes to Directives 90/385, 93/42, 98/79

Textual Amendments

PART 1E+W+SModification of Annexes to Directive 90/385

1.—(1) The Annexes to Directive 90/385 are modified so that they read as if amended by paragraphs 2 to 10.E+W+S

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.

2.  In Annex 1—E+W+S

[F6(za)in Section 2, for “the functions referred to in Article 1(2)(a)” substitute “the purposes referred to in the definition of a medical device in regulation 2(1) of the Regulations]

(a)in Section 8 for the fifth indent substitute —

“–risks connected with ionising radiation from radioactive substances included in the device,”;

(b)for Section 10 substitute—

“10.  Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with an action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC as modified by Schedule 8B to the Human Medicines Regulations 2012.

For the substances referred to in the first paragraph, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing an opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.

Where a device incorporates, as an integral part, a human blood derivative, the approved body shall, having verified the usefulness of the substance as part of the device and taking into account the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing the opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.

Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the approved body shall be informed of the changes and shall consult the Secretary of State, in order to confirm that the quality and safety of the ancillary substance are maintained. The Secretary of State shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the approved body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.

When the Secretary of State has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, the Secretary of State shall provide the approved body with advice on whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The approved body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.”;

(c)in Section 14.2 —

(i)for “the name and address of the authorised representative” substitute “, where such a person is appointed under regulation 21A of the Regulations, the name and address of the UK responsible person,”;

(ii)for “the Community” substitute “the United Kingdom”;

[F7(iii)for “a device within the meaning of Article 1(4a)” substitute “a stable derivatives device]

(d)in Section 15 in the first indent for “CE mark” substitute “UK mark”.

Textual Amendments

3.  In Annex 2—E+W+S

(a)for the heading substitute “Declaration of conformity”;

(b)for “the notified body” each time it occurs substitute “the approved body”;

(c)for “this Directive” each time it occurs substitute “the Regulations”;

(d)in Section 1, for “EC Surveillance” substitute “Surveillance”;

(e)in Section 2—

(i)for “his authorized representative” substitute “their UK responsible person”;

(ii)omit “established within the Community”;

(iii)for “CE marking” [F8, in both places it occurs,] substitute “UK marking”;

[F9(iv)for “Article 12” substitute “regulation 24”;]

(f)in Section 3.1—

(i)in the opening words, for “a notified body” substitute “an approved body”;

(ii)in the fifth indent, for “competent authorities” substitute “Secretary of State”;

[F10(g)in Section 3.2—

(i)in the first paragraph, omit “of this Directive”;

(ii)in point (c), for “Article 5” substitute “regulation 3A of the Regulations”;]

[F11(h)in Section 3.3—

(i)for the first sentence substitute—

“The quality system shall be audited by an approved body to determine whether it meets the requirements referred to in Section 3.2.”

(ii)in the second sentence for “harmonized” substitute “designated”;]

(i)in Section 3.4, in the second paragraph, for the first sentence substitute—

“The proposed modifications shall be evaluated by the approved body so as to verify whether the quality system so modified would still meet the requirements referred to in Section 3.2.”;

(j)in Section 4.2 in the second indent for “Article 5” substitute “regulation 3A of the Regulations”;

(k)for Section 4.3 substitute—

“4.3.  The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, shall issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Regulations may be evaluated. The certificate shall contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.

In the case of devices referred to in Annex 1, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.”;

(l)in Section 4.4, for each reference to “EC design” substitute “design”;

(m)in Section 6.1—

(i)for “national authorities” substitute “Secretary of State”;

(ii)for “his authorised representative” substitute “their UK responsible person”;

(n)for Section 6.2 substitute—

“6.2.  On request, an approved body must make available to other approved bodies and to the Secretary of State all relevant information on approvals of quality systems, issued, refused or withdrawn.”;

(o)for Section 7 substitute—

“7.  Application to the devices incorporating a human blood derivative:

Upon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

Textual Amendments

4.  In Annex 3—E+W+S

(a)in the title for “EC TYPE-EXAMINATION” substitute “TYPE-EXAMINATION”;

(b)for “EC type-examination” in each other place substitute “type-examination”;

(c)for “a notified body” in each place substitute “an approved body”;

(d)for “the notified body” in each place substitute “the approved body”;

(e)in Section 1, for “this Directive” substitute “the Regulations”;

(f)in Section 2—

(i)for the first sentence substitute—

“The application for type-examination shall be made by the manufacturer to the approved body.”;

(ii)for “the authorized representative” substitute “the UK responsible person”;

(iii)for “this Directive” substitute “the Regulations”;

(g)in Section 3, for each reference to “Article 5” substitute “regulation 3A of the Regulations”;

(h)for Sections 4 and 5, substitute—

“4.  The approved body shall—

4.1.  examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation; it shall also record the items which have been designed in accordance with the applicable provisions of the standards referred to in regulation 3A of the Regulations, as well as the items for which the design is not based on the relevant provisions of the said standards.

4.2.  carry out or have carried out the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements where the standards referred to in regulation 3A of the Regulations have not been applied.

4.3.  carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied.

4.4.  agree with the applicant on the place where the necessary inspections and tests will be carried out.

5.  Where the type meets the provisions of the Regulations, the approved body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, the conclusions of the control, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the approved body.

In the case of devices referred to in Annex I, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.”;

(i)in Section 6 omit “EC” each time it occurs;

(j)for Section 7 substitute—

“7.1.  On request, an approved body shall make available to other conformity assessment bodies (including other approved bodies) and to the Secretary of State all relevant information on type-examination certificates and addenda to those certificates issued, refused and withdrawn.

7.2.  The approved body must cooperate with other approved bodies with regard to making available copies of the type examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.

7.3.  The manufacturer or their UK responsible person shall keep with the technical documentation a copy of the UK type-examination certificates and the supplements to them for a period of at least 15 years from the manufacture of the last product.”.

5.  For Annex 4 substitute—E+W+S

“ANNEX 4E+W+SVERIFICATION

1.  Verification is the procedure whereby the manufacturer ensures and declares that the products subject to the provisions of Section 3 are in conformity with the type as described in the type-examination certification and satisfy the requirements of the Regulations that apply to them.

2.  The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the type-examination certification and to the requirements of the Regulations that apply to them. The manufacturer shall affix the UK marking to each product and draw up a written declaration of conformity.

3.  The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the type examination certificate as well as with the relevant requirements of the Regulations.

4.  The manufacturer must undertake to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7. This undertaking must include the obligation on the part of the manufacturer to notify the Secretary of State of the following events immediately on learning of them—

(i)any change in the characteristics or performances and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or deterioration in the patient’s state of health;

(ii)any technical or medical reason resulting in the withdrawal of a device from the market by a manufacturer.

5.  The approved body must carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of the Regulations by examination and testing of products on a statistical basis, as specified in Section 6. The manufacturer must authorize the approved body to evaluate the efficiency of the measures taken pursuant to Section 3, by audit where appropriate.

6.  Statistical verification

6.1.  Manufacturers must present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.

6.2.  A random sample must be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standards referred to in regulation 3A of the Regulations, or equivalent tests must be carried out to verify their conformity to the type as described in the type-examination certificate and thereby determine whether a batch is to be accepted or rejected.

6.3.  Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the designated standards referred to in regulation 3A of the Regulations, taking account of the specific nature of the product categories in question.

6.4.  Where batches are accepted, the approved body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except for those products from the sample which were found not to be in conformity. Where a batch is rejected, the approved body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the approved body may suspend the statistical verification.

The manufacturer may, with the agreement of the approved body, affix the approved body’s identification number during the manufacturing process.

6.5.  The manufacturer or their UK responsible person must ensure that they are able to supply the approved body’s certificates of conformity on request.

7.  Application to the devices incorporating human blood derivative:

Upon completing the manufacture of each batch of devices incorporating human blood derivative the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

6.  For Annex 5, substitute—E+W+S

“ANNEX 5E+W+SDECLARATION OF CONFORMITY TO TYPE

(Assurance of production quality)E+W+S

1.  The manufacturer shall apply the quality system approved for the manufacture and must conduct the final inspection of the products concerned as specified in Section 3; the manufacturer shall be subject to the surveillance referred to in Section 4.

2.  This declaration of conformity is the procedural element whereby the manufacturer who satisfies the obligations of Section 1 guarantees and declares that the products concerned conform to the type described in the type-examination certificate and meet the provisions of the Regulations which apply to them.

The manufacturer must affix the UK marking in accordance with regulation 24 of the Regulations and draw up a written declaration of conformity. This declaration shall cover one or more devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer. The UK marking shall be accompanied by the identification number of the approved body responsible.

3.  Quality system

3.1.  The manufacturer shall make an application for evaluation of their quality system to an approved body.

The application shall include:

3.2.  Application of the quality system must ensure that the products conform to the type described in the type-examination certificate.

All the elements, requirements and provisions adopted by the manufacturer for their quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall include in particular an adequate description of—

(a)the manufacturer’s quality objectives;

(b)the organization of the business and in particular—

(c)the techniques of control and of quality assurance at the manufacturing stage and in particular—

(d)the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will take place, and the test equipment used.

3.3.  Without prejudice to regulation 50 of the Regulations, the approved body shall effect an audit of the quality system to determine whether it meets the requirements referred to in Section 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards.

The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer’s premises.

The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation.

3.4.  The manufacturer shall inform the approved body which has approved the quality system of any plan to alter that system.

The approved body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in Section 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation.

4.  Surveillance

4.1.  The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system.

4.2.  The manufacturer shall authorize the approved body to carry out all necessary inspections and shall supply it with all appropriate information, in particular—

4.3.  The approved body must periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.

4.4.  In addition, the approved body may make unannounced visits to the manufacturer, and must supply the manufacturer with an inspection report.

5.  The approved body shall communicate to the other approved bodies all relevant information concerning approvals of quality systems issued, refused or withdrawn.

6.  Application to the devices incorporating human blood derivative:

Upon completing the manufacture of each batch of devices, incorporating human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

7.  In Annex 6—E+W+S

(a)in Section 1, for “authorised representative established within the Community” substitute “UK responsible person”;

(b)in Section 3 for “the competent national authorities” substitute “the Secretary of State”;

(c)in Section 3.1 for “this Directive” substitute “the Regulations”;

(d)in Section 3.2 for the fourth indent substitute—

“–the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied,”;

(e)in Section 5, in the opening paragraph, for “competent authorities” substitute “Secretary of State”.

[F128.  In Annex 7—E+W+S

(a)in Section 1.1 for “harmonised” substitute “designated”;

(b)in Section 2.3.5 for “all competent authorities of the Member States in which the clinical investigation is being performed” substitute “the Secretary of State”;]

Textual Amendments

9.  In Annex 8—E+W+S

(a)in the title for “when designating inspection bodies to be notified” substitute “when designating approved bodies”;

[F13(aa)in Section 1 for “authorized representative” substitute “UK responsible person”;]

(b)in Section 3 omit the words “and for which it has been notified”;

(c)in Section 6 omit from “unless liability” to the end;

(d)in Section 7 omit from “(except vis-à-vis” to the end.

Textual Amendments

10.  Omit Annex 9.E+W+S

PART 2E+W+SModification of Annexes to Directive 93/42

11.—(1) The Annexes to Directive 93/42 are modified so that they read as if amended by paragraphs 12 to 23.E+W+S

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.

12.  In Annex I—E+W+S

(a)in Section 3, for “Article 1(2)(a)” substitute “regulation 2(1) of the Regulations”;

(b)in Section 7, for “notified body” each time it occurs substitute “approved body”;

(c)for Section 7.4, substitute—

“7.4.  Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC as modified by the Human Medicines Regulations 2012.

For the substances referred to in the first paragraph, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing an opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.

Where a device incorporates, as an integral part, a human blood derivative, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing the opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.

Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the approved body must be informed of the changes and must consult the Secretary of State in order to confirm that the quality and safety of the ancillary substance are maintained. The Secretary of State must take account of the data related to the usefulness of incorporation of the substance into the device as determined by the approved body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.

When the Secretary of State has obtained information on an ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, the Secretary of State must provide the approved body with advice on whether this information has any impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The approved body must take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.”;

(d)in Section 7.5—

(i)for the reference to “Annex 1 to Council Directive 67/548/EEC of 27 June 1967”, substitute “Regulation (EC) No. 1272/2008”;

(ii)for the reference to “Annex 1 to Council Directive 67/548/EEC”, substitute “the UK mandatory classification and labelling list established and maintained in accordance with Article 38A of Regulation 1272/2008”;

(e)in Section 10.3 for “the provisions of Council Directive 80/181/EEC” substitute “the Units of Measurement Regulations 1986”;

(f)in Section 13.3—

(i)in point (a) —

(aa)for the first two references to “the Community” substitute “Great Britain”;

(bb)for the third reference to “the Community” substitute “the United Kingdom”;

(cc)for “the authorised representative” substitute “the UK responsible person (where appointed in accordance with regulation 7A of the Regulations)”;

(ii)in point (f) omit the second sentence;

(iii)in point (n) omit “in the case of a device within the meaning of Article 1(4a),”.

13.  In Annex II—E+W+S

(a)in the title omit “EC”;

(b)for each reference to “the notified body” substitute “the approved body”;

(c)in Section 1 omit “Community”;

(d)in Section 2—

(i)omit “EC”;

(ii)for “this Directive” substitute “the Regulations”;

(iii)for “CE marking” substitute “UK marking”;

(iv)omit the words “in accordance with Article 17”;

[F14(da)in Section 3.1—

(i)in the first sentence, for “a notified body” substitute “an approved body”;

(ii)for “other notified body” substitute “other approved body”;

(iii)for “the competent authorities” substitute “the Secretary of State”;]

(e)in Section 3.2—

(i)in the first paragraph for “this Directive” substitute “the Regulations”

(ii)in point (c)—

(aa)for “Article 5” substitute “regulation 3A of the Regulations”;

(bb)for “Commission Directive 2003/32/EC” substitute “Commission Regulation 722/2012”;

(f)for Section 3.3 substitute—

“3.3.  The approved body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to these requirements.

The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.

The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.”.

(g)for Section 3.4 substitute—

“3.4.  The manufacturer must inform the approved body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The approved body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.”;

(h)in Section 4.2, for “this Directive” substitute “the Regulations”;

(i)for Section 4.3 substitute—

“4.3.  The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, must issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirement of the Regulations may be evaluated. The certificate must contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.

In the case of devices referred to in Annex 1, Section 7.4, second paragraph, the approved body must, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.”;

(j)in Section 4.4, omit each reference to “EC”;

(k)in Section 6.1—

(i)for “authorised representative” substitute “UK responsible person”;

(ii)for “national authorities” substitute “Secretary of State”;

(l)in Section 7.1 for “Article 11(2) and (3)” substitute “regulation 13(2) and (3) of the Regulations”;

(m)in Section 7.2 omit “for compliance with the provisions of this Directive”;

(n)in Section 7.3 omit “for compliance with the provisions of this Directive”;

(o)in Section 7.4 —

(i)for “this Directive” substitute “the Regulations”;

(ii)for “the competent authority” substitute “the Secretary of State”;

(p)for Section 8, substitute—

“8.  Application to the devices incorporating a human blood derivative

Upon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

Textual Amendments

14.  In Annex III—E+W+S

(a)for each reference to “EC type-examination” (including in the title), substitute “type-examination”;

(b)in Section 1—

(i)for “a notified body” substitute “an approved body”;

(ii)for “this Directive” substitute “the Regulations”;

(c)in Section 2—

(i)in the first indent,—

(aa)for “authorized representative” substitute “UK responsible person” ;

(bb)for “the representative” substitute “the UK responsible person”;

(ii)in the second indent, for the second and third sentences substitute—

“The applicant must provide samples at the request of the approved body.”;

(iii)in the third indent, for “notified” substitute “approved”;

(d)in Section 3—

(i)for each reference to “Article 5” substitute “regulation 3A of these Regulations”;

(ii)for “Directive 2003/32/EC” substitute “Commission Regulation 722/2012”;

(e)for Sections 4 and 5 substitute—

“4.  The approved body must—

4.1.  examine and assess the documentation, verify that the type has been manufactured in accordance with that documentation; it must also record the items which have been designed in accordance with the applicable provisions of the standards referred to in regulation 3A of the Regulations, as well as the items for which the design is not based on the relevant provisions of the said standards;

4.2.  carry out or arrange for the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of the Regulations where the standards referred to in regulation 3A of the Regulations have not been applied; if the device is to be connected to another device or other devices in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device having the characteristics specified by the manufacturer;

4.3.  carry out or arrange for the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied;

4.4.  agree with the applicant on the place where the necessary inspections and tests will be carried out.

5.  Where the type meets the provisions of the Regulations, the approved body must issue a type-examination certificate to the applicant. The certificate must contain the name and address of the manufacturer, the conclusions of the inspection, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the approved body.

In the case of devices referred to in Annex I, Section 7.4, second paragraph, the approved body must, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body must give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.

In the case of devices manufactured utilizing tissues of animal origin referred to in Commission Regulation 722/2012, the approved body must follow the procedures referred to in that Regulation.”;

(f)in Section 6—

(i)for each reference to “notified body” substitute “approved body”;

(ii)omit each reference to “EC”;

(g)for Section 7.2 substitute—

“7.2.  An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.”.

(h)in Section 7.3 —

(i)for “authorised representative” substitute “UK responsible person”;

(ii)omit “EC”.

15.  In Annex IV—E+W+S

(a)omit “EC” (including in the title) each time it occurs;

(b)for both references to “this Directive” substitute “the Regulations”;

(c)for each reference to “the Directive” substitute “the Regulations”;

(d)in Section 1 for “authorized representative” substitute “UK responsible person”;

(e)in Section 2—

(i)for “CE marking” substitute “UK marking”;

(ii)for “Article 17” substitute “regulation 10 of the Regulations”;

(f)in Section 3 for “competent authorities” substitute “Secretary of State”;

(g)for Sections 4 to 6 substitute—

“4.  The approved body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Regulations either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides.

The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility.

5.  Verification by examination and testing of every product

5.1.  Every product must be examined individually and the appropriate tests defined in the relevant standards referred to in regulation 3A of the Regulations must be carried out in order to verify, where appropriate, the conformity of the products with the type described in the type-examination certificate and with the requirements of the Regulations which apply to them.

5.2.  The approved body must affix, or have affixed its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out.

6.  Statistical verification

6.1.  The manufacturer must present the manufactured products in the form of homogeneous batches.

6.2.  A random sample must be taken from each batch. The products which make up the sample are examined individually and the appropriate tests defined in the relevant standards referred to in regulation 3A of the Regulations or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the type-examination certificate and with the requirements of the Regulations which apply to them in order to determine whether to accept or reject the batch.

6.3.  Statistical control of products will be based on attributes and/or variables entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the designated standards referred to in regulation 3A of the Regulations, taking account of the specific nature of the product categories in question.

6.4.  If the batch is accepted, the approved body affixes or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform.

If a batch is rejected, the approved body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the approved body may suspend the statistical verification.

The manufacturer may, on the responsibility of the approved body, affix the approved body’s identification number during the manufacturing process.”;

(h)in Section 7—

(i)for “authorised representative” substitute “UK responsible person”;

(ii)for “national authorities” substitute “Secretary of State”;

(i)in Section 8, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;

[F15(zj)in Section 8.2 for “notified body” substitute “approved body”;]

(j)in Section 9—

(i)for the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;

[F16(ia)for “notified body” substitute “approved body”;]

(ii)for the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012”.

Textual Amendments

16.  In Annex V—E+W+S

(a)for “notified body” each time it occurs substitute “approved body”;

(b)omit “EC” each time it occurs, including in the title;

(c)in Section 1, omit “Community”;

(d)in Section 2—

(i)for “this Directive” substitute “the Regulations”;

(ii)for “CE marking in accordance with Article 17” substitute “UK marking”;

(e)in the eighth indent of Section 3.1, for “competent authorities” substitute “Secretary of State”;

(f)in Section 3.3, for the first sentence substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.”;

(g)in Section 3.4, for the last two paragraphs substitute—

“The proposed changes must be evaluated by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.”;

(h)in Section 5.1—

(i)for “authorised representative” substitute “UK responsible person”;

(ii)for “national authorities” substitute “Secretary of State”;

(i)in Section 6 for each reference to “this Directive” substitute “the Regulations”;

(j)in Section 6.3, for “competent authority” substitute “Secretary of State”;

(k)in Section 7—

(i)for the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;

(ii)for the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

17.  In Annex VI—E+W+S

(a)omit “EC” each time it occurs including in the title;

(b)for “the notified body” each time it occurs substitute “the approved body”;

(c)for “this Directive” each time it occurs substitute “the Regulations”;

(d)in Section 2—

(i)for “CE marking in accordance with Article 17” substitute “UK marking”;

(ii)for “CE marking must” substitute “UK marking must”;

(e)in Section 3.1, for—

(i)“a notified body” substitute “an approved body”;

(ii)“other notified body” substitute “other approved body”;

[F17(iii)for “competent authorities” substitute “Secretary of State”;]

(f)in Section 3.3, for the first sentence substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.”;

(g)in Section 3.4, for the second paragraph substitute—

“The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.”;

[F18(ga)in Section 4.4 for “Article 5” substitute “regulation 3A of the Regulations”;]

(h)in Section 5.1—

(i)for “authorised representative” substitute “UK responsible person”;

(ii)for “national authorities” substitute “Secretary of State”;

(i)in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;

(j)in Section 6.3, for “competent authority” substitute “Secretary of State”.

[F19(k)in Section 6.4 for “notified body” substitute “approved body”.]

Textual Amendments

18.  In Annex VII—E+W+S

(a)in the title and in Section 1, omit “EC”;

(b)in Section 1—

(i)for “authorised representative” substitute “UK responsible person”;

(ii)for “this Directive” substitute “the Regulations”;

(c)in Section 2 for—

(i)“his authorised representative” substitute “the manufacturer’s UK responsible person”;

(ii)“national authorities” substitute “Secretary of State”;

(d)in Section 3—

(i)in the opening paragraph for “the Directive” substitute “the Regulations”;

(ii)in the fourth indent—

(aa)for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;

(bb)for “of the Directive” substitute “in Annex I”;

(e)in Section 4, for “competent authorities” substitute “Secretary of State”;

(f)in Section 5, for “the intervention by the notified body” substitute “the intervention by the approved body”;

(g)in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”.

19.  In Annex VIII—E+W+S

(a)in Section 1, for “authorized representative” substitute “UK responsible person”;

(b)in Section 2.2 in the seventh indent for “Directive 2003/32/EC” substitute “Regulation 722/2012”;

(c)in Section 3, for “competent national authorities” substitute “Secretary of State”;

(d)in Sections 3.1 and 3.2, for “this Directive” each time it occurs substitute “the Regulations”;

(e)in Section 3.2—

(i)in the fourth indent, for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;

(ii)in the sixth indent, for “Directive 2003/32/EC” substitute “Regulation 722/2012”;

(f)in Section 5, for “competent authorities” substitute “Secretary of State”.

20.  In Annex IX for “this Directive” each time it occurs substitute “the Regulations”.E+W+S

21.  In Annex X—E+W+S

(a)in Section 1.1 for “harmonised standards” substitute “designated standards”;

(b)in Section 2.3.5 for the words from “all competent authorities of the Member States” to the end substitute “the Secretary of State”.

22.  In Annex X1—E+W+S

(a)in the title, for “notified bodies” substitute “approved bodies”;

(b)for the words “notified body” each time they occur substitute “approved body”;

(c)for each reference to “the Directive” substitute “the Regulations”;

(d)in Section 2, for “national authorities” substitute [F20“Secretary of State”];

(e)in Section 3, for “this Directive” substitute “the Regulations”;

(f)in Section 6, omit the words from “, unless liability” to the end of that Section;

(g)in Section 7, omit the words from “(except vis a vis the competent administrative authorities” to the end.

Textual Amendments

23.  Omit Annex XII.E+W+S

PART 3E+W+SModification of Annexes to Directive 98/79

24.—(1) The Annexes to Directive 98/79 are modified so that they read as if amended by paragraphs 25 to 33.E+W+S

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.

25.  In Annex 1—E+W+S

(a)in Section 3 in part A, for “Article 1(2)(b)” substitute “regulation 2(1) of the Regulations”;

(b)in Section 4.2 in part B, for “Council Directive 80/181/EEC of 20th December 1979” substitute “the Units of Measurement Regulations 1986”;

(c)in Section 8.1 in part B, omit the words from “The decision whether” to the end;

(d)in Section 8.2 in part B, for “harmonised standards” substitute “designated standards”;

(e)in Section 8.3 in part B —

(i)in the first sentence omit “of Directive 67/548/EEC and Directive 88/379/EEC”;

(ii)in the second sentence omit “by those Directives”;

(iii)omit the words from “The provisions of” to the end;

(f)in Section 8.4 in point (a), for the sentence beginning “For devices imported”, substitute—

“Where the manufacturer does not have a registered place of business in the United Kingdom the label, the outer packaging or instructions for use shall contain in addition the name and address of the UK responsible person.”.

26.  In Annex III—E+W+S

(a)in the title and in Section 1, omit “EC”;

(b)in Section 1—

(i)for “authorised representative” substitute “UK responsible person”;

(ii)for “this Directive” substitute “the Regulations”;

(iii)for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(c)in Section 3, for “the Directive” in both places substitute “the Regulations”;

(d)in Section 3, in the sixth indent, for “Article 5” in both places substitute “regulation 3A of the Regulations”;

(e)in Section 5, for “competent authorities” substitute “Secretary of State”;

(f)in Section 6, for “a notified body” substitute “an approved body”;

(g)in Section 6.2—

(i)for “notified body”, both times those words occur, substitute “approved body”;

(ii)in the first sentence, for “this Directive” substitute “the Regulations”;

(iii)in the second sentence omit “of the Directive”;

(iv)for “an EC” substitute “a” ;

(h)in Section 6.3—

(i)for “notified body” in both places substitute “approved body”;

(ii)omit each reference to “EC”;

(iii)for “the Directive” substitute “the Regulations”.

27.  In Annex IV—E+W+S

(a)in the title, omit “EC”;

(b)for each reference to “this Directive” and “the Directive” substitute “the Regulations”;

(c)in Section 2, for “CE marking” substitute “UK marking”;

(d)in Section 3.1—

(i)for “of his quality system with a notified body” substitute “of its quality system with an approved body”;

(ii)in the third indent for “notified body” substitute “approved body”;

(e)in Section 3.3 for the first paragraph substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to the requirements.”;

(f)in Section 3.4, in both paragraphs, for “notified body” substitute “approved body”;

(g)in Section 4.1 for “notified body” substitute “approved body”;

(h)in Section 4.3—

(i)for “notified body” both times those words occur substitute “approved body”;

(ii)for “an EC” substitute “a”;

(i)in Section 4.4—

(i)for “notified body” both times those words occur substitute “approved body”;

(ii)omit each reference to “EC”;

(j)in Section 4.5, for “notified body” both times those words occur substitute “approved body”;

(k)in Sections 5 and 6 for “notified body” each time those words occur substitute “approved body”.

28.  In Annex V—E+W+S

(a)in the title, omit “EC” ;

(b)in Section 1—

(i)for “EC type-examination” substitute “Type-examination”;

(ii)for “a notified body” substitute “an approved body”;

(iii)for “this Directive” substitute “the Regulations”;

(c)in Section 2—

(i)in the first paragraph—

(aa )omit “EC”;

(bb)for “his authorised representative” substitute “its UK responsible person”;

(cc)for “a notified body” substitute “an approved body”;

(ii)in the first indent—

(aa)for “authorised representative” substitute “UK responsible person”;

(bb)for “the representative” substitute “the UK responsible person”;

(iii)in the second indent for “this Directive” substitute “the Regulations”;

(iv)in the second and third indents for “notified body” each time those words occur substitute “approved body”;

(d)in Section 4—

(i)for “notified body shall” substitute “approved body must”;

(ii)for both references to “Article 5” substitute “regulation 3A of the Regulations”;

(iii)for “this Directive” substitute “the Regulations”;

(e)in Section 5—

(i)for “this Directive” substitute “the Regulations”;

(ii)for “notified body” in both places substitute “approved body”;

(iii)for “an EC” substitute “a”;

(f)in Section 6—

(i)for “notified body” each time it occurs substitute “approved body”;

(ii)omit “EC” each time it occurs;

(iii)for “the Directive” substitute “the Regulations”;

(g)for Section 7, substitute—

“7.  An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.”.

29.  In Annex VI—E+W+S

(a)in the title omit “EC”;

(b)in Section 1—

(i)for “EC verification” substitute “Verification”;

(ii)for “authorised representative” substitute “UK responsible person”;

(iii)for “EC type-examination” substitute “type-examination”;

(iv)for “this Directive” substitute “the Regulations”;

(c)in Section 2.1—

(i)for “EC type-examination” in both places substitute “type-examination”;

(ii)for “the Directive” substitute “the Regulations”;

(iii)for “this Directive” substitute “the Regulations”;

(d)in Section 2.2 for “notified body” substitute “approved body”;

(e)in Section 4—

(i)for “notified body” in both places substitute “approved body”;

(ii)for “the Directive” substitute “the Regulations”;

(f)in Section 5.1—

(i)for “Article 5” substitute “regulation 3A of the Regulations”;

(ii)omit “EC”;

(iii)for “the Directive” substitute “the Regulations”;

(g)in Section 5.2 for “notified body” substitute “approved body”;

(h)in Section 6.2—

(i)for “Article 5” substitute “regulation 3A of the Regulations”;

(ii)omit “EC”;

(iii)for “the Directive” substitute “the Regulations”;

(i)in Section 6.3 for “the harmonised standards referred to in Article 5” substitute “the designated standards referred to in regulation 3A of the Regulations”;

(j)in Section 6.4—

(i)for the first two paragraphs, substitute—

“Where the approved body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market.”;

(ii)in the third paragraph, for “notified body”, in both places, substitute “approved body”.

30.  In Annex VII—E+W+S

(a)in the title and in Section 2, omit “EC”;

(b)in Section 2—

(i)for “this Directive” substitute “the Regulations”;

(ii)for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(c)in Section 3.1—

(i)for “a notified body” substitute “an approved body”;

(ii)for “EC type-examination” substitute “type-examination”;

(d)in Section 3.2, for “EC type-examination” substitute “type-examination”;

(e)in Section 3.3 for the first two sentences substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. The approved body must presume that quality systems which implement the relevant designated standards conform to the requirements.”;

(f)in Section 3.4—

(i)for “notified body” substitute “approved body”;

(ii)for the first sentence of the second paragraph substitute “The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would meet the requirements referred to in Section 3.2.”;

(g)in Sections 5.1 and 5.2, for each reference to “notified body” substitute “approved body”.

31.  In Annex VIII—E+W+S

(a)in Section 1—

(i)for “authorised representative” substitute “UK responsible person”;

(ii)for “this Directive” substitute “the Regulations”;

(b)in Section 2, for “the Directive” substitute “the Regulations”;

(c)in Section 3—

(i)for “competent national authorities” substitute “Secretary of State”;

(ii)for “this Directive” substitute “the Regulations”.

32.  In Annex IX—E+W+S

(a)in the title, for “notified bodies” substitute “approved bodies”;

(b)for each reference to “notified body” substitute “approved body”;

(c)in Section 1, for “authorised representative” substitute “UK responsible person”;

(d)in Section 2—

(i)for “the Directive” substitute “the Regulations”;

(ii)for “national authorities” substitute “Secretary of State”;

(iii)for “this Directive” substitute “the Regulations”;

(e)in Section 3—

(i)for “has been notified” substitute “has been designated”;

(ii)for “this Directive” substitute “the Regulations”;

(f)in Section 6, omit the words from “unless liability” to the end;

(g)in Section 7, omit the words from “(except vis à vis the competent administrative authorities” to the end.

33.  Omit Annex X.]E+W+S