The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Amendment of Part VII of the 2002 Regulations

9.—(1) Part VII of the 2002 Regulations is amended as follows.

(2) In regulation 59(1)(interpretation of Part VII)—

(a) omit the definition of “registrable device”;

(b) in the definition of “relevant device” after “IV” insert “or a device for the purposes of Part VIII or IX.”.

(3) In regulation 60(2) (designation etc. of authorised representatives)—

(a) for the heading substitute “Status of UK responsible person”;

(b) omit paragraphs (1) and (2);

(c) for paragraph (3), substitute—

“(3) A UK responsible person—

(a) may be proceeded against as a person placing the device on the market for the purposes of these regulations;

(b) in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.”.

(d) in paragraph (4), for “an authorised representative” substitute “a UK responsible person”.

(4) In regulation 61(3) (enforcement etc.)—

(a) in paragraph (8) in sub-paragraph (a)—

(i) in paragraph (i), after “essential requirement” insert “, a general safety and performance requirement”;

(ii) in paragraph (ii), omit “set out in the Medical Devices Directives”;

(b) in sub-paragraph (b), after “performance evaluation” insert “or study”.

(5) In regulation 62 (compliance notices) in paragraph (1)—

(i) after “performance evaluation” insert “or study”;

(ii) for “the manufacturer or his authorised representative” substitute “any person”.

(6) In regulation 63(4) (restriction notices) in paragraph (1)—

(i) in sub-paragraph (a), after “performance evaluation” insert “or study”;

(ii) in sub-paragraph (b), after “performance evaluation” insert “or study”.

(7) Omit regulation 65(centralised system of records etc.).

(8) In regulation 67(5) (review), for “2019” substitute “2025”.

(9) Omit Schedule 1(6) (association agreements).

(10) For Schedule 2(7) (mutual recognition agreements) substitute—

Regulation 1A

“SCHEDULE 2 Mutual Recognition Agreement countries

• Australia

• New Zealand

• Canada

• The United States of America

• The Swiss Confederation”.

(1)

Regulation 59 was amended by S.I. 2003/1697.

(2)

Regulation 60 was amended by S.I. 2008/2936.

(3)

Regulation 61 was amended by S.I. 2003/1400, S.I.2005/2009 and S.I. 2007/400.

(4)

Regulation 63 was amended by S.I. 2008/2936.

(5)

Regulation 67 was inserted by S.I. 2013/2327.

(6)

Schedule 1 was amended by 2013/2327.

(7)

Schedule 2 was amended by S.I. 2013/2327.