New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU
Newly published: MDCG guidelines for MDR compliance of older medical devices and requirements for parallel imports into the EU.
Medical Devices
MHRA launches public consultation on future of medical device regulation
People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK. Read about it here.
MDR Current Registration Requirements
MDR current Registration Requirements (EUDAMED) for the EU and additional registration requirements for the Republic of Ireland. What is the status?
‘UK Medical Devices Regulation Needs Reform’
The UK Medical Devices Regulation urgently needs reform. This is the conclusion of the UK’s Regulatory Horizons Council in their report on Medical Devices published on the 19th of August 2021. Read their recommendations here.
European Union Harmonized Standards For Medical Devices
The Medical Device Coordination Group of the European Commission has issued new recommendations on the role of standards in the medical device industry.
Digital Therapeutics’ Responsible Integration
Telehealth and digital treatments show promise for improving mental health care, but quality control of the algoritms is still a challenge.
European Commission Publishes Updated Borderline & Classification Manual
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 …