The latest guidance document from the Medical Device Coordination Group, – Guidance on content of the Clinical Investigation Plan for clinic...
WARNING – for all Manufacturers of MDD CE legacy products!
DEADLINE – May 26, 2024! ACT NOW! Submitt your application to your Notified Body and keep your foot on the gas. Keep all your MDD legacy pr...
Flowchart for determining eligibility under the extended MDR transitional period for Devices
The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional per...
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...
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) ...
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...