Tag: medical devices
EMA launches pilot program for expert panel scientific advice in relation to certain high-risk devices
Ten medical device and IVD developers will receive free advice on their clinical development strategies from medical device expert panels. The pilot program aims to help EMA with the implementation of the expert panel advice procedure established in MDR and IVDR.
The European Commission publishes a proposal to amend the transitional provisions foreseen in the Medical Devices Regulation and the In Vitro Diagnostic Medical Device Regulation
Elizabeth Anne Wright and Jessica Lauren Koffel
Read an overview of the proposed amendments to the transitional provisions of the MDR and the IVDR.
Medical devices and IVDs fall outside the scope of the proposed CRA – but for how long?
Elizabeth Anne Wright and Alexander Wenzel
The medical device industry is out of scope of the proposed Cyber Resilience Act
The NIS 2 Directive establishes new cybersecurity requirements for medical device manufacturers
Elizabeth Anne Wright and Alexander Wenzel
Cybersecurity requirements established in the NIS 2 Directive apply to medical device manufacturers
European Commission proposes extension of the transition periods foreseen in the Medical Device Regulation
Read our update on the extension of the transition periods in the Medical Device Regulation
New European Manual on Borderline Classification for medical devices and IVDs
Jessica Koffel and Alexander Wenzel
Read our short overview of the New European Manual on Borderline Classification for medical devices and IVDs
European Commission proposes to up-classify certain beauty equipment falling within EU Medical Devices Regulation
Elizabeth Anne Wright , Emma Bichet and Alexander Wenzel
Read our summary on the proposed up-classification of certain products falling within EU Medical Devices Regulation.
Productwise Bitesize: In Vitro Diagnostic Medical Devices Regulation
Alexander Wenzel and Jessica Koffel
Productwise Bitesize brings you a short introduction to the In Vitro Diagnostic Medical Devices Regulation. Since 26 May 2022, this regulation has been applicable to IVDs, and their manufacturers, importers, distributors and online sales at a distance.
Productwise Bitesize: Medical Devices Regulation
Cooley’s Productwise Bitesize brings you a short overview of the EU Medical Devices Regulation. What is it called? The Medical Devices Regulation (MDR Regulation (EU) 2017/745) governs the placing on the market in the European Economic Area (EEA) of medical devices and its accessories as well as clinical investigations taking […]