As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations

Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility. Cracks in the current...
Could AI Become the New Quality Control Manager in Medical Device Manufacturing?

Europe – Experts outline current knowledge on AI and medical devices

With European legislation on how to regulate the integration of artificial intelligence (AI) into daily life on the horizon, it’s time to consider how...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA and international partners publish five guiding principles for machine learning-enabled medical...

The MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – In vitro diagnostic device regulation in Europe: Update on revisions

The transition from complying with the EU IVDD 98/79/EC to meeting the requirements of the new EU IVDR 2017/746 involves a substantial regulatory framework...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

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...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

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...

NOS PROCHAINES FORMATIONS