The closure of Lloyds Register’s medical devices Notified Body operation

On 13 June 2019, Lloyd’s Register announced that it would no longer be providing medical device Notified Body services:

citing unspecified ‘recent market developments’. As well as closing its UK medical device Notified Body operation, it was also withdrawing its application for medical device notified status in the Netherlands:

As it happens, I heard the news yesterday from medical device manufacturers holding Lloyds Register EC Certificates who I had contacted to enquire about their No Deal Brexit preparations. Their current certificates will now expire on 30 September 2019. But one told me that in such a case where a certificate is soon to expire, the transfer to a new Notified Body takes 6-9 months. They therefore appeared to be faced with a loss of access to the EU27 market.

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