Brexit + MDR Equals Little Certainty For UK And EU Medtech Groups
Medtech stakeholders were reminded recently at the UK's largest regulatory forum that even those willing to make the best of Brexit are still working in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.
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Elżbieta Bieńkowska, a European Commissioner, is "realistic and confident" when it comes to the implementation of the new EU medtech regulations. She says everything is going to plan. But that is not what members of the European Parliament are hearing.
A new "rolling plan" provides deadlines for implementing actions, and other efforts, that are necessary to get the new EU Medical Device and IVD Regulations off the ground.
With just over three weeks to provide input on the UK's proposed regulatory response to the prospect of a no-deal Brexit, Medtech Insight unravels key messages from the four documents issued by the Medicines and Healthcare products Regulatory Agency (MHRA), condensing 127 pages into the main points to aid industry in providing feedback. There's no time to waste for those wishing to influence the outcome.