# The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, Paragraph 11: Amendment of regulation 12 (new Schedules to the 2002 Regulations)


(1) Regulation 12 is amended as follows.
(2) In inserted Schedule 19 to the 2002 Regulations (technical documentation on post-market surveillance for in vitro diagnostic medical devices), in paragraph 5—
(a) for “Article 81” substitute “regulation 189”;
(b) for “Article 80” substitute “regulation 188”.
(3) In inserted Schedule 24 to the 2002 Regulations (conformity assessment based on quality management system and on assessment of technical documentation - in vitro diagnostic medical devices), in paragraph 1(7)—
(a) in the heading, omit “applicable to Class C and Class D devices”;
(b) omit “of Class C and D devices”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111189092/schedule/2/paragraph/11 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-2/paragraph-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.