Medical Devices
The Commission and the EU Member States have created MDR and IVDR tables with an overview of language requirements for manufacturers of medical devices.
New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU Introduction There is a need for improved MDR compliance of older devices in the EU. There is also a need to review the requirements related to parallel imports. Therefore, the Medical Device Coordination ... Read more
'Philips is liable for health problems' say users of apnea devices. Four users of a Philips device used to treat sleep apnea, the Dreamstation 1, are holding the manufacturer liable for health problems. Their lawyer Mr. Mark de Hek has announced this in a letter to the company. The users ... Read more
MHRA seeks consultation MDR, press release on https://www.gov.uk People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK. From:Medicines and Healthcare products Regulatory Agency and The Rt Hon Sajid Javid MPPublished16 September 2021 MHRA seeks consultation MDR – MHRA launches public consultation ... Read more
UKCA mark for medical devices: The practicalities Itoro Udofia, director, Medical Health Service at TÜV SÜD, a global product testing and certification organisation, explains what you need to know about the UKCA mark. UKCA marking (UK Conformity Assessed marking) is the UK product marking requirement that is now required for any product ... Read more
MDR current Registration Requirements (EUDAMED) for the EU and additional registration requirements for the Republic of Ireland. On May 26, 2021, the Medical Devices Regulation (MDR) became completely applicable throughout the EU. It is a much-anticipated strengthening of Europe's existing medical device regulatory framework, and it imposes important new requirements ... Read more
Sir Bruce Keogh has a clear message: the UK Medical Devices Regulation needs urgent reform. On the 19th of August 2021, the former Medical Director of the UK’s National Health Service presented the conclusions of a report of the Regulatory Horizons Council (RHC). The RHC describes the report as a ... Read more
ICMRA: permanent AI-working group is needed Artificial intelligence is evolving at a rapid pace. Therefore, it is challenging current regulations on medicines and medical devices. This is evident from a global inventory by the ICMRA (International Coalition of Medicines Regulatory Authorities. This international consortium of regulators wrote a report on ... Read more
New Recommendations European Union Harmonized Standards For Medical Devices: the Medical Device Coordination Group (MDCG) of the European Commission has issued new recommendations on the role of standards in the medical device industry (the Guidance). The Guidance explains how harmonised European standards (hENs) are governed. It also explaines the advantages ... Read more
Digital therapeutics' responsible integration into mental health care becomes an increasingly important topic. As digital tools grow more popular, it's critical to think about how to conform them into mental health care responsibly. The way forward demands continuous focus on proper oversight and care models Also data protection and justice ... Read more