Europe – Data generated from ‘Off-Label’ Use of a device under the EU Medical...
‘Off label use’ is mentioned within the Medical Device Regulation (MDR) in Annex XIV Part B, in the context that manufacturers should proactively identify...
Europe – Santé publique: plus de temps pour certifier les dispositifs médicaux afin de...
La Commission a adopté aujourd'hui une proposition visant à accorder plus de temps certifier les dispositifs médicaux afin de limiter le risque de pénuries. La...
Europe – GUIDANCE on the content and structure of the summary of the...
This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of...
Europe – Compliance for medical device makers in the EU and Turkey just got...
Good news for medical device and in vitro diagnostic (IVD) device makers doing business in the European Union (EU) and Turkey: compliance just got simpler....
Europe – Commission publishes implementing regulation on specifications for class D diagnostics
For certain class D in vitro diagnostic medical devices falling within the scope of Regulation (EU) 2017/746, harmonised standards do not exist as regards certain...
Europe – Notified bodies survey on certifications and applications
Notified Bodies Survey on certifications and applications (MDR/IVDR) - MDCG & Stakeholders...
Europe – MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as...
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on...
Europe – The clock is ticking – MedTech Europe’s recommendations ahead of May 2025...
Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening,...
Europe – Uniformiser le processus d’enregistrement des DM à l’échelle de la planète
Le paysage réglementaire mondial continue d'évoluer rapidement en matière de medtech ; de nouvelles exigences sont mises en place et le nombre de marchés...
UK – Medical devices: UK approved bodies
UK approved bodies for medical devices...
