Medical Devices Archives | Page 9 of 52 | PAGB

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New MHRA MedTech Blog Post

MHRA has published the June edition of the MedTech blog.

European Commission Implementing Regulation on Electronic Instructions for Use for Medical Devices Published in Official Journal

The Commission Implementing Regulation (EU) 2025/1234 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form has been published in the Official journal.

MHRA AI Airlock Pilot (Medical Devices) – Phase 2 testing

MHRA has announced that their Phase 2 AI Airlock testing is open for applications. Applications are open from 23 June to 12 July 2025.

MDCG – Guidance on Medical Device Software (MDSW) Apps on Online Platforms

The Medical Device Coordination Group (MDCG) 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms has been published on the European Commission website.

EUDAMED – Stuttgart Event Recordings Available

On 21 May a hybrid event on EUDAMED was held in Stuttgart. The purpose of this session was to support the EUDAMED onboarding, to prepare for compliance with the Regulations in view of its mandatory use. The recordings of the event have now been published.

MHRA Safety Roundup May 2025

MHRA's safety bulletin, the MHRA Safety Roundup, for May 2025 has been published. This includes a summary of all safety alerts (including Drug Safety Updates) published during the month for medicines and medical devices.

EU – COMBINE Program for Clinical Trials and Medical Devices – Pilot Launch

As part of the COMBINE programme, Member State authorities have launched a pilot to test a new, more efficient way of approving combined studies.

New Post-Market Surveillance Regulation In Force

As of 16 June, the new Post-Market Surveillance regulation for medical devices takes effect. The new regulation applies to all UKCA- and CE-marked devices placed on the GB market from 16 June 2025.

MHRA Guidance Update: Medical Devices Post-market Surveillance and Vigilance

The new Post-market Surveillance and Vigilance regulations for medical devices will come into force on 16 June 2025. MHRA has published the final data standards and guidance for Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs) in Great Britain (GB), for the upcoming GB reporting requirements. In addition, a short presentation on the changing regulations providing further clarifications following stakeholder feedback has been shared.

MHRA RegulatoryConnect Webinar Recording

MHRA has published the recording of the RegulatoryConnect webinar which took place on 22 May 2025.

One Week To Go: MHRA Webinar – An Overview of the New Post-Market Surveillance SI

PAGB is hosting a session with MHRA to support members in understanding the new Post-Market Surveillance Statutory Instrument (PMS SI) and guidance. The webinar will take place on Monday 9 June 10.00 to 11.00.

JRC Consultation on EU Harmonised Label for Packaging Waste

The Joint Research Centre (JRC) of the European Commission has launched a targeted stakeholder consultation as part of their technical work on the harmonised label. The survey aims to gather more detailed feedback on the design aspects of material-based waste sorting labels to be applied to product packaging and waste receptacles across the EU. The deadline to respond is 16 June.