IMQ Appointment As Fourth Notified Body Under MDR: Good News But Big Questions
There are now four notified bodies designated under the new EU Medical Device Regulation. But that is not enough, and new designations do not mean immediate testing either.
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With just 98 days until the full application of the Medical Devices Regulation, the European Commission’s target of having 20 notified bodies designated has nearly been reached.
There could be pressure to postpone the EU MDR given COVID-19 fears have delayed discussions over vital concessions related to its implementation. The problems over already-scarce notified body resources could risk being compounded further given all of Italy's notified bodies appear to be located in quarantined areas.
The consensus among the UK MHRA, the national medtech industry and notified bodies remains that convergence of regulatory systems is the preferred route for the UK once it has left the EU. Meanwhile, the regulator is planning for all eventualities, as a recent parliamentary forum on the post-Brexit regulatory landscape heard.