Clinical evaluation

Latest Articles

ARTICLE

Happy 2025 – more churn for MDR and IVDR!

Erik Vollebregt

Happy new year everyone! I hope you had a good rest over the holidays because 2025 will be interesting. I am planning to revive this blog this year and hope to put new energy in it by making it more periodical with smaller bits of information and shorter analysis. You will still get my unique […]
Filter articles on Medical Devices Legal
Filter articles on Axon
ARTICLE

Impossible and Incredible And Yet Really Happened

Karin Verzijden What can we learn from the Impossible vs. Incredible case in the Netherlands? At the end May this year, the Court of The Hague rendered a remarkable judgment: at the request of Impossible Foods, Nestlé was banned from launching its INCREDIBLE BURGER in the EU. How is this possible? Impossible Foods is not even on […]
Filter articles on Food Health Legal

More Articles

Article

Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

, Erik Vollebregt Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to…
Read more

Article

New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

, Erik Vollebregt The EU just released its first MEDDEV of a number that were agreed upon in the recent MDEG meeting. More are expected to trickle onto the Commission’s devices web pages in the coming…
Read more

Article

Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 2

, Erik Vollebregt In a previous post I gave a number of practical tips for drafting ISO 14155 clinical trial agreements. In this post I will give another few. Additional points will surely come to…
Read more

Article

Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 1

, Erik Vollebregt In my day-to-day legal practice I see a number of points related to clinical investigation that seem to return and repeat all the time and thought it a good idea to share…
Read more

Article

Outlines of the medical devices Recast become more fixed with Council conclusions

, Erik Vollebregt Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the…
Read more

Navigate through our knowledgebase

advertisingappsauthorised representativeBorderlinebusiness complianceCE MarkCE markingClinical evaluationClinical investigationClinical TrialsCybersecurityData ProtectioneHealthenforcementENVIEucomedEudamedfoodhealthhealth claimsIn vitro diagnosticsinformationIVDIVDRivdslabellingLiesemarket surveillanceMDRMEDDEVMedical devicesmhealthNotified Bodiesnotified bodyNovel Foodnutrition claimspersonal dataPMAPMSprivacyQuality systemRecastreprocessingrevisionRoth-BehrendtSoftwarestandardstechnologyUDIUnannounced audits