Products

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

French government meets with healthcare industry at eighth meeting of the Strategic Council for the Healthcare Industries

Eveline Van Keymeulen

The eighth meeting of the Strategic Council for the Healthcare Industries (CSIS), between the French government and representatives of the healthcare industry, took place on 10 July 2018. The CSIS agreed on certain measures as part of a long-term roadmap to help France regain its attractiveness as an international centre of health innovation and excellence. Read More

Dutch government survey: “Are the supplementary protection mechanisms for pharmaceutical products fit for their purpose?”

Anna-Maria Withagen

Supplementary protection mechanisms have succeeded in achieving most of their aimed objectives, according to a study by the Technopolis Group that was commissioned by the Dutch government. However, another conclusion of the study is that the mechanisms seem to have various unintended effects as well. These effects still have to be further investigated. Below is Read More