The International Medical Device Regulatory Forum (IMDRF) published the last piece of a code system which may be used worldwide for various applicatio...
New MDCG guidance documents!
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-bin...
New and current standards have been harmonized with the current directives!
On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on the market de...
New documents published by the European Commission!
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) ...
