Module 18 2021

UK regulation of medical devices – 1 January 2021

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EU Exit & EU MDR/IVDR delay

• Regulation 2017/745 (EU MDR) entered into force on 25 th May 2017 • Original date of full implementation: 26 th May 2020 • Date of full application of MDR fell within EU Exit transition period

• Regulation 2020/561 amending the MDR • Full implementation of MDR delayed to 26 th May 2021 – outside the EU Exit transition period • MDR and IVDR not automatically retained by EU Withdrawal Agreement Act

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