Key Terms and Concepts in the Medical Device Regulation – Vigilance The vigilance requirements under the EU’s medical device regulations c...
MDCG Guidance Document on IVD classification
MDCG guidance document on IVD classification If you’re involved in the manufacture or sale of in vitro diagnostic medical devices (IVDs) in the ...
Standard Fees for Notified Bodies under MDR and IVDR
Standard Fees for Notified Bodies under MDR and IVDR The Medical Device Coordination Group (MDCG) has released a new document, MDCG 2023-2 This docume...
The MDCG Position Paper On The Temporary Use Of Article 97 Of The MDR
Article 97 – Expiring medical device certificates (Temporary application of Article 97 MDR) The Medical Devices Coordination Group’s (MDCG...
EU MDR Bridge
EU MDR Bridge Deadline/transition – further info! What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy ...