(EU)2021/2226 explained: Electronic Manuals for Medical Devices
(EU)2021/2226 explained: Electronic Manuals for Medical Devices – published on cemarking.net –
Medical Devices Directive
Irish NSAI Expects Approval to get EU MedTech Certification
The Irish NSAI expects approval to get the EU MedTech
EU-MDR Lurches Towards US-FDA Approach
The EU MDR (Medical Device Regulation) tends to follow the approach of the US FDA (Food and Drug Administration). In the current situation, it tightens the existing regulatory framework for medical devices in Europe in a way that is unacceptable to many market participants.
Compliance And The Growth Of The Medical Industry
Compliance and the growth of the medical industry, does it work together? This question is highly relevant because the growth in the medical device industry is significant. And also, this will continue to be the case for the foreseeable future.
The European Commission confirms proposal to postpone the MDR
The European Commission confirms: it is preparing a proposal to postpone the implementation of the Medical Device Regulation (EU) 2017/745 with one year.
Medical devices and IVDs: List European harmonised standards updated
The European Commission has published an update of the list of European harmonised standards under the Medical Devices Directive (93/42/EC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostics Directive 98/79/EC.
Medical Device Regulation (MDR): new guidance documents published
Today, the European Union’s advisory organ for medical devices, the