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...
The UK never ending story comes to an end!
We published a Brexit News & Views beginning of October for our clients to react, if needed, should a hard Brexit occur, which was on the horizon...
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...
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 ...
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...
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...