http://www.legislation.gov.uk/uksi/2021/905/regulation/29/made
The Medical Devices (Northern Ireland Protocol) Regulations 2021
en
King's Printer of Acts of Parliament
2021-07-27
MEDICAL DEVICES
CONSUMER PROTECTION
These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017) (“Regulation (EU) 2017/745”). Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement between the United Kingdom and the European Union (“the Protocol”) provides that the EU law listed in Annex 2 to the Protocol will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/745 is listed in Annex 2 and applied from 26 May 2021. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/745 in domestic law.
The Medical Devices (Northern Ireland Protocol) Regulations 2021
PART 8Amendment of the Medical Devices Regulations 2002
Amendments to the Medical Devices Regulations 200229
The Medical Devices Regulations 200211 are amended in accordance with this Part.