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MedTech Europe Warns on MDR Implementation Issues
MedTech Europe, the association of companies that operate on the medical device market, is deeply concerned with the current situation regarding the implementation of Regulation 2017/745 (MDR). The association warns...
European Commission has Announced New Nomenclature
The European Commission (EC) has released two new guidance related to the nomenclature of medical devices. CND Nomenclature: Key Points   The first document published by the EC describes the “Classificazione Nazionale...
Notified Bodies and Conformity Assessment in the EU
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. Notified Bodies: Legal...
MDCG Issues Guidance On Class I Medical Devices
The Medical Device Coordination Group (MDCG), the advisory body of the European Commission, is composed of the representatives of all EU Member states and is entitled to provide clarification regarding the...
AEMPS Provides Additional Time to Change Labels
The Spanish Agency of Medicines and Medical Devices (AEMPS) announced the extension of the period provided for medical device manufacturers to implement changes to labeling required due to Brexit. A General Overview of...