Europe – MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
Software has become an increasingly important part of the medical device landscape. It is
estimated that one in four medical devices either incorporate medical device...
Europe – Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device...
Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002...
Europe – The European Medical Technology in Figures 2023
Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business leaders and policymakers.
Updated regularly, this platform draws on data from...
Europe – Convergence: MDR timeline extension is smoothing transition, but concerns persist
The European Union’s Medical Device Regulation (MDR) timeline extension has addressed some of the issues manufacturers raised with the transition period but the process...
Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs a year,...
The European Commission’s plan to reform pharmaceutical legislation could cause three fewer rare disease drugs to come to market each year, according to a...
UK – Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
From 1 January 2021 the Medicines and Healthcare...
Europe – Ongoing consultations under the PECP
This page lists the views provided by the in vitro diagnostics expert panel under the Performance Evaluation Consultation Procedure (PECP) according to Article 48(6)...
Europe – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro...
In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices...
Europe – Evaluation clinique : retours d’expérience d’un organisme notifié
Avec le Règlement (UE) 2017/745 sur les dispositifs médicaux (RDM), l’évaluation clinique est devenue une étape centrale dans l’évaluation de la conformité des produits,...
UK – Three new UK Approved Bodies to certify medical devices announced by the...
TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices...
