Planned Meetings of MDCG and Subgroups in 2025 Published The EC has released the 2025 meeting schedule for MDCG and its subgroups. Planned Meetings of MDCG and Subgroups in 2025 Published
New MHRA Chair: Anthony Harnden Appointed MHRA has elected a new chair. New MHRA Chair: Anthony Harnden Appointed
MHRA Future Medical Device Regulations Consultation MHRA has launched a public consultation to seek views on proposals to update four areas of the future regulatory framework for medical devices and in vitro diagnostic (IVD) devices. MHRA Future Medical Device Regulations Consultation
MHRA Publishes Statement of Policy Intent: Relaunch of ILAP The new ILAP will open to applications in March 2025, with full details of the pathway to be published in January 2025. MHRA Publishes Statement of Policy Intent: Relaunch of ILAP
Q&A on Practical Guidance for Implementing Notification Obligations for Supply Interruptions or Discontinuations of Certain Devices Published The European Commission has released a Q&A document detailing guidance on fulfilling notification obligations for supply interruptions or discontinuations of certain devices, as required under the MDR and IVDR. Q&A on Practical Guidance for Implementing Notification Obligations for Supply Interruptions or Discontinuations of Certain Devices Published
AESGP Webinar – Online Trade of Consumer Healthcare Products AESGP is hosting a webinar, 'Online Trade of Consumer Healthcare Products under the EU’s Digital Markets Act and Digital Services Act', on Tuesday 3 December, from 11.30 to 13.00 (GMT). AESGP Webinar – Online Trade of Consumer Healthcare Products
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
