Accessories

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

Happy New Year – with all those developments

, Erik Vollebregt The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year…
Read more

Article

E-labelling regulation published, no changes / big disappointment

, Erik Vollebregt Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did)…
Read more

Article

The new EU MEDDEV on stand-alone software as medical device

, Erik Vollebregt Some time ago I already gave you a look under the hood of it and now it is here, the new MEDDEV on stand alone software: an interesting document that provides a…
Read more

Article

Regulating Medical Software and nothing new on the Recast

, Erik Vollebregt Today I attended the COCIR workshop Regulating Medical Software in Brussels, a very interesting event that brought a lot of new information to my attention and I had the opportunity to speak…
Read more

Article

EU Court judgment may add 6.5% customs tariff burden for parts/accessories of medical devices

, Erik Vollebregt And now for something completely different: customs tariffs. Dry stuff, but it makes all the difference for the price of the device. Indeed, ‘parts’ and/or ‘accessories’ under heading 9018 of the Combined…
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