Surprise As UK Notified Bodies Lose Major Part Of Their UK Role In Devices From March 29
There is now even more urgency for medtech companies, including small firms, to employ the services of EU27 notified bodies – with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.
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How many notified bodies have been designated under the new EU Medical Device and IVD Regulations? Medtech Insight looks at the Nando database to monitor developments.
One In Three Medtech Innovators Will Be 'Driven Out Of Business' By EU MDR, German Business Survey Finds
The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.
The UK’s 2019 medtech regulations laid in Parliament last week in preparation for a possible no-deal Brexit at the end of March are long and difficult to read. Medtech Insight spoke to the Medicines and Healthcare products Regulatory Agency to find out the essentials.