The European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry (COCIR) has called for a transition period to enable medical devices certified by a UK Notified Body (NB) to continue to be used in the EU following Brexit.
Regulatory Affairs Professionals Society (Raps) reported on the COCIR’s open letter to the European Commission, in which it urged politicians to act in “the best interests of our citizens”.
The COCIR pointed out that, in the event of a no-deal scenario, UK NBs will no longer be able to issue EU certificates. That means that all non-EU manufacturers will need to change any UK authorised devices to EU ones.
As a result of what the COCIR described as “major concerns” for the industry if there is a no-deal Brexit, it has asked for the European Commission to introduce a transition period for medical device manufacturers, which would provide a six-month grace period for transitions to new NBs.
The letter added that “even 12 to 18 months could be necessary in case manufacturers have to switch to a completely new Notified Body to ensure the necessary time for the recertification”.
With Theresa May granted an extension by Brussels to 12 April, there is a little more time before the UK crashes out of the EU with no deal. However, the prime minister must get her deal through parliament, after twice having it defeated, before this date.
Otherwise the alternatives are a much more lengthy extension to Article 50, or a no-deal Brexit.
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