Medical Devices Archives

MHRA & Department for Education Embed Medicine Safety Into School Curriculum

The importance of medicine safety and how to report side effects of medicines via the Yellow Card scheme is now part of the statutory guidance for schools in England.

MHRA Blog – Looking to Our Future: Reflections on the Strategic Choices Ahead for the MHRA

MHRA is publishing a series of blogs on the challenges and opportunities ahead. In the first instalment, Chief Executive Lawrence Tallon reflects on the changing healthcare landscape, the regulator’s role, and the priorities shaping the agency’s future direction.

MHRA MedTech Blog Post – September

MHRA has published the September edition of the MedTech blog. In this post MHRA Head of Diagnostics and General Medical Devices, Joseph Burt, shares updates on key initiatives advancing medical device and IVD regulation in the UK.

European Commission Launches Call for Evidence to Streamline Device Regulations

The European Commission has opened a call for evidence (until 6 October 2025) on its initiative to simplify EU rules for medical devices and IVDs, aiming to streamline the framework, cut costs, and remain proportionate while safeguarding health and safety.

DHSC Public Appointments

The Department of Health and Social Care (DHSC) has published information about non-executive appointments to DHSC's public bodies and committees in September 2025.

EU Medical Devices – Borderline Manual Under EU MDR and IVDR – Updated Version

The European Commission has published an updated version of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

EU Medical Devices – Updated Schedule for 2025 MDCG and Subgroup Meetings

The European Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2025.

MHRA Medical Devices: Standardised Format for PMSR

MHRA has published guidance on 'medical devices: standardised format for the post market surveillance report' with the intention to provide information and recommendations for manufacturers on the preparation and presentation of a post market surveillance report (PMSR).

MHRA Publishes Updated Government Response to the Consultation on Statutory Fees for Medical Devices

MHRA has now published an update to the Government Response to the MHRA Consultation on Statutory Fees setting out the final proposals for introducing a new annual fee to fund post-market surveillance of medical devices.

MHRA Survey: Designated Standards Prioritisation

MHRA has launched a survey to seek input on the prioritisation for designation of important device standards that support compliance with MDR 2002 to help inform the ongoing prioritisation process for device standards designated.

EMA ICH Consultation – Q3E Draft Guideline for Extractables and Leachables & Supporting Documentation

The European Medicines Agency (EMA) has published for public consultation the draft International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Q3E Guideline for extractables and leachables and ICH Q3E Guideline for extractables and leachables - supporting documentation: class 3 leachable monographs.

EUDAMED Workshops

The European Commission is organising two more free hybrid workshops on the European database on medical devices (EUDAMED). The primary goal of the workshops is to help stakeholders understand what the mandatory use of EUDAMED will mean and raise awareness on the timelines for its use.