Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The...
USA – FDA updates guidance on identifying and responding to deficiencies
The US Food and Drug Administration has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the...
Europe – 37 ème organisme notifié au titre du Règlement 2017/745
37 ème organisme notifié au titre du Règlement 2017/745
USA – FDA draft guidance covers low-level light therapy devices
The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are...
USA – Legacy devices report highlights need for data to support future policies
More data is needed to understand the risks legacy connected medical devices pose to the healthcare system, particularly in their vulnerability to cyberattack. That...
Australia – New guidance published on manufacturer evidence for IVD medical devices
We no longer accept ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a...
International – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device...
Standards perform a key role in the conformity assessment process; however, utilizing
existing standards for recognition of medical device CABs performing regulatory
reviews presents challenges. Regulatory...
France – Déclarer l’indisponibilité d’un dispositif médical : la procédure évolue
A partir du 1er septembre 2024, la procédure pour anticiper et gérer l’indisponibilité de dispositifs médicaux (DM) et dispositifs médicaux in vitro (DMDIV) évolue, dans la continuité...
France – L’ANSM demande aux fabricants de dispositifs médicaux qui envoient un avis de...
Des concertations menées par l’ANSM avec des pharmaciens qui distribuent ou utilisent des dispositifs médicaux ou dispositifs médicaux de diagnostic in vitro, montrent que la...
International – Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
The scope of this guidance document is limited to the information participating IMDRF
Regulatory Authorities require in medical device regulatory review reports, the format of
reports,...
