Team-NB Views on Implementation of EU MDR/IVDR Regulations Team-NB has published a press release sharing its views on the implementation of the EU MDR/IVDR regulations. Team-NB Views on Implementation of EU MDR/IVDR Regulations
SI Laid in Parliament Sets Out First Steps in Delivering Medical Device Regulatory Reform The Post-market Surveillance Statutory Instrument (SI) was published in Parliament on 21 October, this is the first major update to the framework of medical device regulations in GB. SI Laid in Parliament Sets Out First Steps in Delivering Medical Device Regulatory Reform
Invest 2035: The UK’s Modern Industrial Strategy The Department for Business and Trade has launched a green paper consultation on its proposals for a national long-term industrial strategy. Invest 2035: The UK’s Modern Industrial Strategy
MDCG 2021-25 Rev 1 on Legacy Devices Published The MDCG 2021-25 Rev. 1 on the application of EU MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC has been published on the Commission website. MDCG 2021-25 Rev 1 on Legacy Devices Published
AESGP Webinar – The Impact of the Revised CLP Regulation on the Self-care Sector AESGP is hosting a webinar on the impact of the revised classification, labelling and packaging (CLP) regulation on the self-care sector, in collaboration with Fieldfisher, on Tuesday 12 November. AESGP Webinar – The Impact of the Revised CLP Regulation on the Self-care Sector
EU Overview of Applications for Designation as NB Updated The Commission has updated the overview of the applications for designation as a Notified Body (NB) under the EU MDR and IVDR. EU Overview of Applications for Designation as NB Updated
Commission Publishes Updated List of 2024 MDCG Meetings The Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2024. Commission Publishes Updated List of 2024 MDCG Meetings
Webinar – The Opportunities for Quantum Sensing in Healthcare ABHI, UKQuantum and the Department for Science, Innovation and Technology’s Office for Quantum are running a webinar on the transformative potential of quantum sensors in medical sensing and diagnostics on Monday 25 November between 2 - 3:15pm. Webinar – The Opportunities for Quantum Sensing in Healthcare
50th Notified Body Designated Under the EU MDR Hungary-based Notified Body ‘NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)’ has been notified as the 49th Notified Body under the EU MDR. 50th Notified Body Designated Under the EU MDR
DSIT Announce New Regulatory Innovation Office The Department of Science, Innovation, and Technology (DSIT) has announced the launch of the new Regulatory Innovation Office (RIO). The RIO’s primary goal is to reduce red tape and accelerate public access to emerging technologies, supporting economic growth in the process. DSIT Announce New Regulatory Innovation Office
MHRA AI Airlock Pilot MHRA has announced their AI Airlock pilot is open for applications. The application is open for 2 weeks, until 7 October 2024, and MHRA is encouraging applications from innovators and developers of AI medical device products and prototypes to come forward. MHRA AI Airlock Pilot
MHRA Control Testing Guidance Updates Published MHRA has published updates to the following control testing guidance to reflect the requirements of the Windsor Framework. MHRA Control Testing Guidance Updates Published
