[F1SCHEDULE 2AE+W+SModification of Annexes to Directives 90/385, 93/42, 98/79

Textual Amendments

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

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”;

[F2(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”;

[F3(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