Team-NB released annual sector survey informing medical device community on the status of valid/new/withdrawn CE Certificates as well as on the changes in the NB personnel. The survey covered solely members of the Team-NB, which represent 26 Notified Bodies altogether.
In view of the upcoming regulatory framework that will increase the requirements on both manufacturers and Notified Bodies, 2018 saw an increase in CE Certificates of 30% (4992 in total) and increase of NB full-time employees by 24%.
It was equally reported that there were 1120 CE Certificates withdrawn due to cessation of activity, financial issues, negative assessment result, transfer / no longer manufacturing product, BREXIT and others.
Team-NB informed of positive status update. Last year, 80% of the TEAM-NB members submitted their applications to be designated under the new Regulations. In May 2019, 10 members are in the last phases before the designation. Read more on the status of NB destination.
If you wish to remain updated and know more about the changes brought by the new Regulations visit MDlaw.eu – Information Platform on the EU Medical Device Regulations; and do not hesitate to contact us if you need assistance with our Notified Body Selection Service!
Ajda Mihelčič
Deputy Manager of Publishing Department
July 2, 2019
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