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...
Total excitement on social media because of MDR Corrigendum!
In Europe the regulatory community follows closely the latest MDR developments. The rumors, that certain class I products may receive a significant ex...
NO INDEPENDENT UK RESPONSIBLE PERSON (RP) POSSIBLE!!!
Brexit and Medical Devices UK RESPONSIBLE PERSON = IMPORTER What we already evaluated was strongly confirmed by a representative of the UK MHRA. And ...