The Medical Devices (Northern Ireland Protocol) Regulations 2021

Clinical investigations not carried out for a purpose specified in Article 62(1) N.I.

17.—(1) The provisions in paragraph (2) apply to clinical investigations of custom-made devices carried out for a purpose other than one of the purposes specified in Article 62(1), in addition to the provisions specified in Article 82(1).

(2) The provisions are—

(a) those of Article 62(4) not already specified in Article 82(1);

(b) Article 62(5) and (7);

(c) Article 63 except—

(i) in paragraph (2)(e), not the words “include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and”; and

(ii) in paragraph (6), not the words “in the electronic system on clinical investigations referred to in Article 73”;

(d) Articles 64 to 69;

(e) Article 70 except—

(i) in paragraph (1), not the first sentence of the second subparagraph;

(ii) in paragraph (2), not the final sentence of the paragraph, and in the first sentence the words “data in the electronic system referred to in Article 73” to the end are to be read “documentation and submit the updated documentation to the Secretary of State”;

(iii) in paragraph (3), in the first subparagraph, not the words “by means of the electronic system referred to in Article 73”; and

(iv) paragraphs (8) and (9);

(f) Article 71;

(g) Article 72;

(h) Article 75 except in paragraph (1), not the words “by means of the electronic system referred to in Article 73”;

(i) Article 76 except—

(i) in paragraph (3), not the words “by means of the electronic system referred to in Article 73”; and

(ii) in paragraph (4), not the words “through the electronic system referred to in Article 73”;

(j) Article 77 except—

(i) in paragraphs (1) and (7), not the words “through the electronic system referred to in Article 73”;

(ii) paragraph (4);

(iii) in paragraph (5), not the second sentence of the second subparagraph;

(iv) paragraph (6); and

(v) in paragraph (7), in the second subparagraph, the words “entered into the electronic system pursuant to paragraph (5) of this Article” are to be read “submitted pursuant to paragraph (5) of this Article”;

(k) Article 80 except—

(i) in paragraphs (2) and (3), not the words “by means of the electronic system referred to in Article 73”; and

(ii) paragraphs (4) and (5);

(l) Annex XV except section 3.1.1 in Chapter II.

Commencement Information

I1 Reg. 17 in force at 27.7.2021, see reg. 1(2)