Team-NB publishes a statement to emphasize that Notified bodies members work within a strict regulatory framework and put patient safety at the heart of their decision making …
Team-NB-PositionPaper-20181124
The Commission published 3 new factsheets targeted at :
Authorised representatives, importers and distributors - AR Importers distributors Person in charge of procurement of medical devices and in vitro medical devices - Procurement ecosystem_ Competent authorities in non EU/EEA countries - Third Countries
59th NB-Med meeting is planned on 16 and 17th October in Brussels.
The meeting is held in two parts. The first part is a meeting with representatives of Notified Bodies only and the second part of the meeting will take place with representatives of Notified Bodies, of the Industry association and from European Commission.
Documents related to the new regulations are available
on the DG Growth's website : https://ec.europa.eu/growth/sectors/medical-devices/guidance_en
Article from Patrick Renard in DeviceMed
https://www.devicemed.fr/dossiers/reglementation/ou-en-est-la-designation-des-organismes-notifies-de-team-nb/17144?utm_content=article&utm_medium=mail&utm_campaign=newsletter-20181004&utm_source=newsletter
Further analyze of the responses of the July CIRCABC survey on the capacities of notified bodies : both the staff resource and certificates issued.
Team-NB-Press-Release-July-Survey-Capacities-20180820
Factsheets for manufacturers are available on the Commission website under the title “Information for manufacturers”:
https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en md_mfr_factsheet