The European Commission confirms: it is preparing a proposal to postpone the implementation of the Medical Device Regulation (EU) 2017/745 with one year.
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.
Today, the European Union’s advisory organ for medical devices, the
MEDICAL DEVICE MAKERS based in Ireland are ramping up their
The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit. Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week.
Today, the BBC published this article on failing active implantable medical devices:
On October 30, 2018 the European Commission published a new version of the Borderline & Classification Manual. This manual is intended to provide guidance on the status of medical devices and in vitro diagnostics and their risk classifications.
The French Notified Body ANSM (The National Security Agency of Medicines and Health Products) recommended breast implants produced by Cereplas to be recalled from the European market.