- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3
Commission Implementing Regulation (EU) No 920/2013 is up to date with all changes known to be in force on or before 18 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
For the purposes of this Regulation, the following definitions shall apply:
‘device’ means active implantable medical devices as defined in [F1regulation 2(1) of the Medical Devices Regulations 2002];
‘conformity assessment body’ means a body which performs calibration, testing, certification and inspection activities under Article R1(13) in Annex I to Decision No 768/2008/EC of the European Parliament and of the Council(1);
[F2“approved body” has the same meaning as in regulation 2(1) of the Medical Devices Regulations 2002;]
[F3“accreditation” means an attestation by a national accreditation body conveying formal recognition that a conformity assessment body is competent to carry out a specific activity;]
F4...
F5...
‘on-site assessment’ means a verification in the premises of the body or of one of its subcontractors or subsidiaries by the [F6Secretary of State];
‘surveillance on-site assessment’ means a periodic routine on-site assessment which is neither the on-site assessment undertaken for the initial designation, nor the on-site assessment undertaken for the renewal of the designation;
‘observed audit’ means [F7the Secretary of State’s] assessment of the performance of a notified body’s audit team in the premises of the body's client;
‘functions’ means the tasks to be fulfilled by the body’s staff and its external experts, namely: auditing of the quality systems, product related technical documentation review, review of clinical evaluations and investigations, device testing and, for each of the previously mentioned items, the final review and decision making thereon;
‘subcontracting’ means the transfer of tasks to one of the following:
a legal person;
a natural person who further delegates these tasks or parts thereof;
several natural or legal persons who jointly perform these tasks.
Textual Amendments
F1Words in Art. 1(a) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 17
F2Art. 1(c) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 18
F3Art. 1(d) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 19
F4Art. 1(e) omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 20
F5Art. 1(f) omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 20
F6Words in Art. 1(g) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 21
F7Words in Art. 1(i) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 22
In this Regulation, any reference to Annex 8 to Directive 90/385 or to Annex XI to Directive 93/42 is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A to the Medical Devices Regulations 2002.]
Textual Amendments
F8Art. 1a inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 23
The criteria set out in Annex 8 to Directive 90/385/EEC or in Annex XI to Directive 93/42/EEC shall be applied as laid down in Annex I.
1.When applying for designation as [F10an approved body], a conformity assessment body shall use the application form set out in Annex II. If the conformity assessment body submits the application and documents annexed to the application on paper, it shall also submit an electronic copy of the application and its annexes.
The application shall specify the conformity assessment activities, the conformity assessment procedures and the fields of competence for which the conformity assessment body wishes to be [F11approved], the latter by indicating the codes [F12found in Guidance: UK approved bodies for medical devices https://www.gov.uk/publications/medical-devices-uk-approved-bodies-for-medical-devices.]
2.[F13The Secretary of State] shall assess that body in accordance with an assessment check-list that covers at least the items listed in Annex II. The assessment shall include an on-site assessment.
F14...
F153.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F154.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F155.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F156.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.F16...
The validity of the designation shall be limited up to a maximum of five years.
Textual Amendments
F9Word in Art. 3 heading substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 24(a)
F10Words in Art. 3(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 24(b)
F11Word in Art. 3(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 24(c)(i)
F12Words in Art. 3(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 24(c)(ii)
F13Words in Art. 3(2) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 24(d)(i)
F14Words in Art. 3(2) omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 24(d)(ii)
F15Art. 3(3)-(6) omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 24(e)
F16Words in Art. 3(7) omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 24(f)
1.An extension of the scope of the [F17approved] body's designation may be granted in accordance with Article 3.
2.A designation as [F18an approved] body may be renewed in accordance with Article 3 before the end of the validity period of the previous designation.
3.For the purposes of paragraph 2, the procedure set out in Article 3(2) shall include, where appropriate, an observed audit.
4.Extension and renewal procedures may be combined.
[F195.An approved body, within the meaning of regulation A45(1)(b) of the Medical Devices Regulations 2002, whose designation does not have a stated validity period or has a validity period exceeding five years, is to be subject to a renewal within five years of IP completion day]
[F206.By way of derogation from paragraph 2, during the period from 19 May 2020 to 25 May 2021, the designating authority of a Member State, in extraordinary circumstances resulting from the COVID-19 pandemic and due to the adoption of Regulation (EU) 2020/561 of the European Parliament and of the Council(2) deferring the application of certain provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council(3), may decide to renew a designation as notified body without having recourse to the procedures laid down in Article 3.
In order to decide on the renewal of a designation as notified body in accordance with the first subparagraph, the designating authority shall carry out an assessment in order to verify the continuous competence of the notified body and its ability to perform the tasks for which it was designated.
The decision on the renewal of a designation as notified body in accordance with this paragraph shall be adopted before the end of the validity period of the preceding designation and shall automatically become void at the latest on 26 May 2021.
The designating authority shall notify the Commission of its decision, giving substantive reasons therefore, on the renewal of a designation as notified body in accordance with this paragraph by means of the ‘New Approach Notified and Designated Organisations’ Information System.
The Commission may require a designating authority to provide it with the results of the assessment supporting the decision on the renewal of a designation as notified body in accordance with this paragraph, as well as the outcome of related surveillance and monitoring activities, including those referred to in Article 5.]
Textual Amendments
F17Word in Art. 4(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 25(a)
F18Words in Art. 4(2) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 25(b)
F19Art. 4(5) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 25(c)
1.For the purpose of surveillance, the [F21Secretary of State] shall assess an appropriate number of [F22approved] body’s reviews of the manufacturer’s clinical evaluations and shall carry out an appropriate number of file reviews, surveillance on-site assessments and observed audits at the following intervals:
(a)at least every 12 months for [F22approved] bodies with more than 100 clients;
(b)at least every 18 months for all other [F22approved] bodies.
That designating authority shall, in particular, examine changes which have occurred since the last assessment and the work the [F22approved] body has performed since that assessment.
[F20By way of derogation from the first and second subparagraphs, in exceptional circumstances relating to the COVID-19 pandemic that temporarily prevent the designating authority of a Member State from carrying out surveillance on-site assessments or observed audits, it shall carry out any measures to ensure an adequate level of surveillance that remain possible under those circumstances in addition to the assessment of an appropriate number of the [F22approved] body’s reviews of the manufacturer’s technical documentation, including clinical evaluations. [F23The Secretary of State] shall examine changes to the organisational and general requirements set out in Annex II that have occurred since the last on-site assessment and the activities the [F22approved] body has performed thereafter.]
2.Surveillance and monitoring conducted by the [F24Secretary of State] shall appropriately address subsidiaries.
3.[F25The Secretary of State shall continuously monitor that body to ensure ongoing compliance with the applicable requirements. The Secretary of State shall provide for a systematic follow-up of complaints, vigilance reports and other information, including from outside the United Kingdom, which might indicate the non-fulfilment of the obligations by an approved body or its deviation from common or best practice.]
In addition to surveillance or renewal on-site assessments, the [F26Secretary of State] shall initiate unannounced or short-notice on-site assessments if those on-site assessments are needed to verify compliance.
Textual Amendments
F20Inserted by Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies (Text with EEA relevance).
F21Words in Art. 5(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(a)(ii)
F22Word in Art. 5(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(a)(i)
F23Words in Art. 5(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(a)(iii)
F24Words in Art. 5(2) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(b)
F25Words in Art. 5(3) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(c)(i)
F26Words in Art. 5(3) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(c)(ii)
The Secretary of State may investigate cases regarding the competence of an approved body or the fulfilment of the requirements and responsibilities to which an approved body is subject under the Medical Devices Regulations 2002.]
Textual Amendments
F27Art. 6 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 27
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F28Art. 7 omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 28
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F29Art. 8 omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 28
Where designation is based on accreditation within the meaning of Regulation (EC) No 765/2008, the Secretary of State shall ensure that the accreditation body that has accredited a particular approved body is kept informed of incident reports and other information that relate to matters under the control of the approved body when the information may be relevant for the assessment of the performance of the approved body. The Secretary of State must ensure that the accreditation body in charge of the accreditation of a particular conformity assessment body is kept informed of findings relevant for the accreditation. The accreditation body shall inform the Secretary of State of its findings.]
Textual Amendments
F30Art. 9 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 29
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply to extension of designations as from 25 December 2013.
F31...
Textual Amendments
F31Words in Signature omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 30
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.
Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.
Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys