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Guidance - MDCG endorsed documents and other guidance
- https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
- The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. They are drafted in collaboration with interested parties represented in the various groups and …
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- Medical devices with an ancillary medicinal substance ─ the notified body must seek EMA's scientific opinion on the quality, safety, and usefulness of the ancillary …
Notified Bodies - Public Health
- https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies_en
- A notified body Search for available translations of the preceding link EN ••• is an organisation designated by an EU Member State (or by other countries under …
NBOG Documents
- https://www.nbog.eu/nbog-documents/
- It provides guidance to authorities on the execution of their responsibilities for the designation, monitoring and control of Notified Bodies in the medical devices sector. It …
Notified body recommendations - PubMed
- https://pubmed.ncbi.nlm.nih.gov/11010318/
- This article discusses the Notified Body recommendations issued by the European Forum of Notified Bodies Medical Devices and its subcommittee, the Notified Bodies …
mdc medical device certification GmbH - Notified Bodies …
- https://www.mdc-ce.de/downloads/guidelines/notified-bodies-recommendations.html
- Notified Bodies Recommendations | Notified Bodies Recommendations NB-MED documents comprise of recommendations accepted by the European Forum of Notified …
Home - Welcome to Team NB | Team NB
- https://www.team-nb.org/
- Team-NB is the European Association of Notified Bodies active in the Medical device sector. The members are Notified Bodies under any or all of the three medical device …
List of Notified Bodies under MDR on Medical Devices
- https://akrnconsulting.com/list-of-notified-bodies-mdr/
- There are specific Notified Bodies (NBs) dedicated to performing the conformity assessment of medical devices, precisely 56 NB under Directive 93/42/ECC. However, there are many fewer NBs …
Notified bodies are government accredited - Johner Institute
- https://www.johner-institute.com/articles/regulatory-affairs/and-more/notified-bodies/
- ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;“ Source: MDR According to the Medical Device Directive (MDD) respectively Medical Device Regulation (MDR) …
mdc medical device certification GmbH - Notified Bodies …
- https://www.mdc-ce.de/downloads/leitlinien/notified-bodies-recommendations.html
- Notified Bodies Recommendations NB-MED Recommendations sind Empfehlungspapiere, welche vom Europäischen Erfahrungsaustausch der Benannten …
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