What is the regulatory process for medical devices in the UK?
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- Опубліковано 6 сер 2024
- The medical device industry planned and prepared for the implementation of the new EU MDR Regulation for almost a decade.
Just before the EU MDR came into force, Brexit occurred.
➤ www.government.nl/topics/brex...
Everyone expected a mutual recognition agreement with the EU, but that did not happen. The "deal" is almost as bad as "no deal" or maybe even worse.
The final decision was the EU member states will not recognize the UKCA marks or certificates from UK approved bodies. In retaliation, the UK will not recognize the CE Mark or CE quality system certificates from Notified Bodies. Therefore, CE Marked products will only be allowed in the UK for some products until December 31, 2022. For medical devices, the deadline will be June 30, 2023. After that date, you must have a UKCA mark on your device to sell in the UK.
There are only three UK approved bodies, and there are two others that have applied to be approved bodies.
Even then, questions still remain:
What if your Notified Body is not a UK Approved Body?
What if your ISO 13485:2016 quality certification is not from a BSI or SGS?
What if a UKCA mark is not granted prior to the July 1st deadline?
If you would like to learn about the regulatory process for medical devices in the UK, please register on our website:
➤ medicaldeviceacademy.com/ce-m...
Pre-orders are available until March 31, 2022 at a 50% discount for $64.50. - Наука та технологія
June 2023 will be a very interesting time for UK Medical Devices for better or for worse? we will just have to wait and see
I expect the lack of approved bodies in the UK to be the biggest short-term challenge. I would have preferred to have seen the UK join the MDSAP certification process rather than insist upon UK approved bodies. But the decision seems political rather than strategic.
Is UKCA requirement also applicable for Gibraltar?
It's a great question, but I don't know the answer. I submitted the question to MHRA and I will add a comment once I receive their response.
I like your hat
Thank you Noah. It's my favorite color, and Cabot is such as beautiful golf course.
No link down below 🙃
I added an arrow to the two links in the description. If you are looking for something else, please let me know and I'll update the description again.