DEKRA, the German-based company, has been chosen by The European Commission as the third notified body to be accredited under the Medical Device Regulations (MDR). The new regulations come into effect on May 26th 2020.
Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application. The date of MDR application has moved to May 26th, 2021. Articles that were written prior to the delay referenced the earlier date. However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration. Read more here.
Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application. The date of MDR application has moved to May 26th, 2021. Articles that were written prior to the delay referenced the earlier date. However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration. Read more here.
DEKRA’s accreditation to act as a notified body comes amidst considerable disquiet within the medical devices sector about the delay in accrediting new Notified Bodies and the fact that, to date, only 3 have been accredited. DEKRA will join TÜV SÜD and BSI as the only NB’s designated and listed in The European Commission’s NANDO database (New Approach Notified and Designated Organisations ).
In recent months we have been working with several companies that have been forced to identify a new NB following the decision of LRQA to exit the Notified Body sector. The LRQA notified customers in June 2019 that they planned to exit the sector. Customers were then given 90 days in which to identify a replacement NB.
Acorn Regulatory has been assisting medical device companies in choosing a new Notified Body. If you would like to speak to our medical device experts then please get in touch with us by contacting us on 00353 5261 76 706 or by completing the webform below.
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