Medical devices

Getting ready for the EU MDR: Requirements for identification and traceability of medical devices

Eveline Van Keymeulen

In this post of our “Getting ready for the MDR” series, we analyse the most important requirements for device identification and traceability that will be imposed on manufacturers and other economic operators placing medical devices on the EU market. MedTech Europe, the association representing the European medical technology industry, estimates that approximately 500,000 different medical devices Read More

French data protection authority (CNIL) publishes reference methods for health data processing

Laurie-Anne Ancenys

On 16 July 2018, the French Data Protection Authority (CNIL) published revised and new reference methods (MRs) regarding data processing in health research to adapt the existing framework to the EU General Data Protection Regulation (GDPR) and the national health data system (SNDS). Specifically, the CNIL updated: MR-001 on interventional research. MR-003 on non-interventional research. It also Read More

The Netherlands: New borderline products advisory group established

Iradj Nazaryar

On 9 July 2018, the establishment of the new Advisory Group on the Determination of the Status of Borderline Products was published in the Dutch Government Gazette. The Advisory Group consists of expert representatives from the Healthcare and Youth Inspectorate, the Dutch Food and Consumer Product Safety Authority, the Medicines Evaluation Board and the Central Committee Read More

Medical devices industry calls for more time to implement EU Medical Devices Regulation

Jacqueline Bore

MedTech Europe, the European trade association representing the medical technology industries, has called on the European Commission, European Parliament and EU member states to allow more time for the implementation of the changes to the regulatory scheme for medical devices brought about by the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), Read More

Brexit White Paper: UK’s proposals on future relationship with EU acknowledge the needs of the Life Sciences industries

Jacqueline Bore

The UK government published its long awaited White Paper, “The Future Relationship between the United Kingdom and Europe”, on 12 July 2018.  The White Paper details the UK government’s comprehensive vision for the future relationship between the UK and the EU-27, which it describes as the “Future Framework”. The proposals that affect the Life Sciences Read More