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. MHRA Webinar: An Overview of the New Post-Market Surveillance SI
Commission Publishes Updated List of 2025 MDCG Meetings The Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2025. Commission Publishes Updated List of 2025 MDCG Meetings
EU MDR – Notified Bodies Survey on Certifications & Applications The European Commission has published the Notified Bodies Survey on certifications and applications (EU MDR/IVDR) based on data collected from 51 notified bodies until 31 October 2024 EU MDR – Notified Bodies Survey on Certifications & Applications
New MORE Guidance on Implementing the Changing Data Requirements for Medical Device Reporting To support the implementation of the PMS regulations, MHRA has published new guidance on the changes to GB reporting requirements for serious incidents and field safety corrective actions (FSCA) including an implementation guide which clarifies the changing data requirements and the timelines for compliance. New MORE Guidance on Implementing the Changing Data Requirements for Medical Device Reporting
New EPR Guidance for ‘Small Producers’ Organisations classed as 'small producers' must register and report packaging data annually to comply with the EPR scheme as detailed in the new Defra guidance. New EPR Guidance for ‘Small Producers’
MIR Form 7.3.1 Mandatory from November 2025 The European Commission has published a new version of the manufacturer incident report (MIR) form on its website. This form is mandatory from November 2025. MIR Form 7.3.1 Mandatory from November 2025
MHRA NIMAR Guidance Updated MHRA has published an updated version of the the Northern Ireland MHRA Authorised Route (NIMAR) guidance. This update includes revisions related to advertising and promotions, as well as information aligned with the Windsor Framework. NIMAR provides a route for the lawful supply of Prescription-Only Medicines in compliance with UK and EU rules, where there is a risk that clinical need in Northern Ireland for that product cannot be met. MHRA NIMAR Guidance Updated
MHRA RegulatoryConnect Webinar MHRA will be hosting a webinar on RegulatoryConnect on Thursday 22 May between 3.30-5pm. The aim of the webinar is to provide a comprehensive update on the programme, share plans for 25/26 and discuss some of the changes users will see, to help them prepare for the next release. MHRA also plan to share ongoing opportunities for feedback and involvement. MHRA RegulatoryConnect Webinar
Statutory Fee Increase and Action Required in DORS From Q1 financial year 2025/26, the medical devices registration fee will rise from £240 to £261. Ahead of this change, companies must submit any draft (TEMP) applications in DORS, otherwise they will be deleted the day prior. Statutory Fee Increase and Action Required in DORS
17th Notified Body Designated Under EU IVDR Norway based Notified Body ‘DNV Product Assurance AS’ has become the 17th Notified Body under the EU IVDR.. 17th Notified Body Designated Under EU IVDR
AESGP Webinar – Ethanol BPR & CLP Procedures Impact on Self-care Products Greece has submitted a CLH Registry of Intention for Ethanol hazard classification including Repr. 2. To explore the potential impact of a CMR1A or CMR1B classification on self-care products, AESGP is hosting a webinar on Thursday 15 May 12.30–13.30 CEST. AESGP Webinar – Ethanol BPR & CLP Procedures Impact on Self-care Products
New MHRA MedTech Blog Post MHRA has published the April edition of the MedTech blog. New MHRA MedTech Blog Post
