The European Commission’s newly released Q&A on Article 10a of the MDR and IVDR (Medical Device Regulation and In Vitro Diagnostic Regulation) i...
Guidance for Clinical Investigation Plan under MDR: Key Highlights!
The latest guidance document from the Medical Device Coordination Group, – Guidance on content of the Clinical Investigation Plan for clinic...
WARNING – for all Manufacturers of MDD CE legacy products!
DEADLINE – May 26, 2024! ACT NOW! Submitt your application to your Notified Body and keep your foot on the gas. Keep all your MDD legacy pr...
Exciting developments regarding Harmonized Standards!
M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the Eu...
For risk class I manufacturer!
Warning: No additional transition for risk class I products. Products who are risk class I and stay of risk class I must fully comply to t...
Use of Symbols to Indicate Compliance with the MDR!
MedTech Europe issued in December an update on the List of Symbols.pdf, which may be useful to consider in particular for the transition to the MDR. ...
IMPORTANT, Important … Guidance for class I manufacturer!
MDCG 2019-15 – Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December. And other guidance...
New Vigilance documents published on the European Commission website!
The following important vigilance documents have been published on the European website: Additional guidance on the MEDDEV 2.12/1 rev.8 Device speci...
European Commission offers Guidance on UDIs!
Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device i...
New information on expert panels published
The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies...
