UK – MHRA and international partners publish five guiding principles for machine learning-enabled medical...
The MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support...
UK – MHRA guidance on new Medical Devices Post-Market Surveillance requirements
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance is designed to help medical device manufacturers...
UK – MHRA warns of unsafe counterfeit anti-choking devices
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not...
Switzerland – New organisational structure with separate Medical Devices Surveillance Sector
For the strategy period 2023-2026, Swissmedic’s objectives include making legal responsibilities for medical devices more visible and stepping up international collaboration in this area....
Europe – Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices...
Europe – MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of...
The Medical Device Coordination Group (MDCG) has introduced new guidance under MDCG 2024-16, streamlining how manufacturers report interruptions or discontinuations in the supply of...
Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
Clinical outcome assessments (COAs), used in clinical studies (whether they are interventional (also called experimental), or observational), are a key component of health technology...
Europe – EU device expert warns manufacturers not to wait until the last minute...
AN EU medical device expert advised manufacturers to avoid submitting applications at the last minute for approval under the Medical Devices Regulation (MDR) and the In Vitro...
Europe – Annual report 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully...
Europe – Pilot on the Advice from the Expert Panels to Manufacturers of HighRisk...
Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation, MDR) Article 106 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (In Vitro...
