- Contingency legislation covering regulation of medicines, medical devices and clinical devices in a no-deal scenario—Medical Devices (Amendments etc) (EU Exit) Regulations 2019
- Original news
- What is the purpose of the Exit Regulations?
- What are the relevant amendments to the current regime introduced by the Exit Regulations?
- Notified bodies
- Authorised representatives
- Designated standards and conformity assessment
- Registration of devices and persons placing devices on the UK market
- Data exchange/Eudamed
- How do the Exit Regulations ensure the continuity of supply of medical devices for the UK?
- Are there any gaps in the proposed UK post-Brexit regimes for medical devices as set out by the Exit Regulations?
- Do the Exit Regulations provide clarity as to whether and how the upcoming reform to the EU regulatory framework governing medical devices will apply in the UK?
- What will be the impact of the amended UK regulatory framework on the life sciences businesses?
Life Sciences analysis: As part of our series on contingency legislation covering the regulation of medicines, medical devices and clinical trials in a no-deal scenario, Michaela Herron, senior associate at Bristows, looks at the draft Medical Devices (Amendments etc) (EU Exit) Regulations 2019 (the Exit Regulations).
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