Emerging Roadmap and Transition Provisions – MHRA Blog Post MHRA has published the latest Med Tech Regs update blog, written by Laura Squire, the Chief Healthcare Quality and Access Officer. The blog post is on the Emerging Roadmap and transition provision. Emerging Roadmap and Transition Provisions – MHRA Blog Post
Life Sciences Innovative Manufacturing Fund (LSIMF): Expression of Interest The Life Sciences Innovative Manufacturing Fund (LSIMF) is open and will accept Expression of Interests (EOI) on a rolling basis. The government has committed up to £520 million for life sciences manufacturing, to help deliver on the government’s missions to kickstart economic growth and build an NHS fit for the future. Life Sciences Innovative Manufacturing Fund (LSIMF): Expression of Interest
MDCG Guidance – Regulatory Status of Ethylene Oxide (EtO) Intended for Sterilisation of Medical Devices The Medical Device Coordination Group (MDCG) has endorsed the guidance document 'Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices (MDCG 2024-13)'. MDCG Guidance – Regulatory Status of Ethylene Oxide (EtO) Intended for Sterilisation of Medical Devices
Post-Market Surveillance SI Update – MHRA Blog Post 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. MHRA's Laura Squire, the Chief Healthcare Quality and Access Officer, has written a blog post to update on MHRA's plans for Med Tech regulatory change. Post-Market Surveillance SI Update – MHRA Blog Post
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
