Time Right For MDR/IVDR Completion: Devices Guru Predicts Success – But With Possible Casualties
This article was originally published in Clinica
Executive Summary
Gert Bos, executive director and partner at Qserve Group, says that talks on the European Commission’s original September 2012 proposals for a new EU Medical Device Regulation and IVD Regulation have progressed far enough and it is now time to adopt new rules.
You may also be interested in...
EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas
March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.
EU’s Revised Phthalates Guideline Features New Annexes Focused On Alternatives
The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.
Non-Medical Brain Stimulation Devices: Could They Be Down-Classified Again In the EU?
Six types of products that do not have an intended medical purpose fall under the scope of the Medical Device Regulation. Understanding their risks is complex and subject to regular re-examination by the European Commission.