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The Notified Bodies are reviewing the Commission Notice 2021/C 8/01 published 11 January 2021. We are drafting a consensus paper so that we can approach our designating authorities with consistent risk assessment criteria to apply to remote audits. We hope to share our consensus paper before the end of January 2021.
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
Analyse of the survey results launch on mid-June on CIRCABC related to transparency on designation process.
Team-NB-Press-Release-Applications-Survey-20180720
BioWorld MedTech article on Medical Devices CE marking
BioWorld MedTech-20180228
Scrip Regulatory Affairs “Two EU notified bodies join international pilot to test common submission format for devices”
2 Notified bodies joined a pilot program that is being run by the International Medical Device Regulators Forum to test a common electronic submission format for reviewing device submissions.
Commission published 2 documents
• A Regulation on the designation and the supervision of notified bodies • A Recommendation on the audits and assessments performed by notified bodies