The consolidated text also includes the MDR delay. From now on we would not expect any major changes anymore. Consolidate text (EN).pdf For other lang...
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...
MDR Delay!
2020.04.24 In writing and set in stone with the publication on the Official Journal of the European Union. Here is the publication. 2020.04.20 On Frid...
Notified body number 11!
The notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as one of the smaller notified bodies...
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...
MDR deadline for risk class I Manufacturers – Ready to appoint MDSS as your MDR EC REP?
The MDR deadline for Manufacturers of risk class I products is approaching. The days until May 26, 2020 are numbered! It is fundamental that class I M...
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) ...
Second Corrigendum to the MDR and IVDR
This update gives certain Class I manufacturer a break. On December 27 the second corrigendum was published in the official Journal of the EU. This up...
MDR Transition!
Plan with your EC REP to get your products ready to market by May 2020. The deadline is approaching quickly and EC REPs resources need to be allocate...