The temptation when I sat down to draft this editorial was to go with the obvious! Discuss the one topic that seems to dominate every news broadcast. What? No Brexit I hear you ask! We have a saying in the UK, “today’s newspaper is tomorrow’s fish and chip wrapper” and it’s perfectly highlighted by the fact that having a Brexit story on the news would now be a welcome change. But very recently the implications of it became once again relevant to our specialist sector.
So, I mention Brexit (with a heavy heart and at great risk of having rotten fruit thrown at me) because this month the UK government announced its plans for medical device regulation in the UK post December 2020. For those looking for progress, well, take a deep breath. The document on regulating medical devices from the 1st of January 2021 states:
“The MDR and IVDR will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. As these regulations will not take effect until after the transition period with the EU has ended, they will not be EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain.“
Currently, devices in the UK are regulated under:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)