Germany’s Health Minister has asked the European Commission for a Brexit medical device contingency plan
Germany’s Federal Minister of Health, Jens Spahn, has written a letter to the European Commission warning of potential medical device supply issues in the event of a no-deal Brexit, and requests EU member states develop a contingency plan.
In the letter seen by Handelsblatt, Spahn says:
“In the case of an unregulated Brexit, it is reasonable to assume that tens of thousands of medical devices lose their formal marketability in the EU-27 and are therefore no longer available on the European market”.
Spahn has specifically called for accelerating and streamlining of the procedures by which EU organisation’s assume control of UK certification and has asked for a transitional period for UK-certified medical devices. During this 12-month period, manufacturers with UK certification could continue to distribute their products in the EU without formal certification, under the condition that the companies have submitted plans to obtain EU authorisation. Cardiac pacemakers and blood sampling products were identified as being of particular concern and would require new approval following the UK’s withdrawal from the EU which could result in shortages at “latest from mid-April”.
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