We will comment based on the feedback and questions MDSS may receive. State of play of joint assessments of Notified Bodies in the medical device sect...
Warning – For risk class I devices!
Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that...
Standards free of charge!
CEN and CENELEC make European standards freely available relevant for the crisis. Standards are created by standard organizations who carefully draf...
Agenda of the MDCG and the MDCG subgroups has been released!
The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below). Most...
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. ...
New documents published by the Commission!
– The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED! The European Medical Device Nomenclature (EMDN) ...
New Guidance published by the Commission!
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR)(hereafter called the Medical DevicesRegulations) have ...
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...