EU MDR and the United Kingdom.
29/6/2021
Over the last decade, Medical Regulations and compliance have had a considerable impact on medical device businesses. While the companies who sell their products in the EU market are busy achieving conformity with the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), companies in the UK are facing ‘big time’ changes due to Brexit. Companies are pushing for changes in the law as current regulations seem to be acting as a barrier to innovation.
The Medicines and Medical Devices Act passed into law on 11th February 2021 enabling the UK to build their own regulatory system. Significant progress is being made, but there is no update about when this framework will be fully implemented.
1st January 2021 officially marked the beginning of the UK’s departure from Europe and the transition to the UK’s own regulatory regime with a series of deadlines and defined export phases for exporting goods to Great Britain and Northern Ireland.
The transition phase of the UK Medical Device Regulations (UK MDR) 2002 continues to apply in England, Scotland and Wales (i.e. Great Britain).
CE Marked medical devices will be accepted in Great Britain up until 30th June 2023 which is deemed to be sufficient time for manufacturers to plan and strategise the regulatory framework.
Guidelines for Northern Ireland
Our experts have issued new steps to keep in mind, especially if you are a medical device manufacturer based in the United Kingdom. Read the detailed blog here.
In these complex times, don’t let regulations hold back your innovations!
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