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Regulatory Affairs Newsletter Archive

Public consultation: Conformity Assessment Procedures for medical devices – Proposed amendments Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Public consultation: Conformity Assessment Procedures for medical devices – Proposed amendments

Dear Members, please be advised that TGA Australia are running a consultation on the Conformity Assessment Procedures for medical devices – proposed amendments. The consultation closes 27th Feb 2026. Please provide any feedback to regulatory@bivda.org.uk This is particularly relevant as TGA Australia is a proposed jurisdiction that will be recognised by the MHRA for international reliance, under the proposed changes…
Ben Kemp
January 12, 2026
IMDRF issued their 2026-2030 strategic plan Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

IMDRF issued their 2026-2030 strategic plan

Dear Members, IMDRF issued its 2026-2030 strategic plan. The strategic plan outlines the mission, objectives, and priorities of the International Medical Device Regulators Forum (IMDRF). This directly and indirectly impacts BIVDA members, one by setting the guidance that a number of key regulators base their legislative principles on, and also increasingly by setting the minimum requirements that allow international reliance…
Ben Kemp
January 12, 2026
EU IVDR/MDR revision proposal Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

EU IVDR/MDR revision proposal

Dear members, please see the link below to the European Commission's initial proposal to revise the EU MDR and IVDR. Please note that this is just an initial proposal and is subject to the usual EU trilogue process between the EC, the European Parliament, and the European Council. This process could take 18 months to 3 years, typically before a…
Ben Kemp
January 12, 2026
FDA Guidance updates FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance updates

Dear Members, please note the following FDA Guidance Document updates issued since 15/12/2025: Final Guidance: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices | FDA Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FDA Processes and Practices Applicable to Bioresearch Monitoring Inspections | FDA Clinical Decision Support Software | FDA General Wellness: Policy for…
Ben Kemp
January 12, 2026
CELEX:32025L2647: Directive (EU) 2025/2647 of the European Parliament and of the Council of 16 December 2025 amending Directive 2013/11/EU on alternative dispute resolution for consumer disputes and amending Directives (EU) 2015/2302, (EU) 2019/2161 a European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025L2647: Directive (EU) 2025/2647 of the European Parliament and of the Council of 16 December 2025 amending Directive 2013/11/EU on alternative dispute resolution for consumer disputes and amending Directives (EU) 2015/2302, (EU) 2019/2161 a

Dear Members, please see below updated EU legislation regarding Consumer Protection and dispute resolution. This impacts Business to Consumer transactions e.g for self-test devices, and includes digital products and services. Directive (EU) 2025/2647 of the European Parliament and of the Council of 16 December 2025 amending Directive 2013/11/EU on alternative dispute resolution for consumer disputes and amending Directives (EU) 2015/2302,…
Ben Kemp
January 12, 2026
CELEX:32025R2605: Council Regulation (EU) 2025/2605 of 12 December 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation (EU) No 952/2013 of the European Parliament European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025R2605: Council Regulation (EU) 2025/2605 of 12 December 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation (EU) No 952/2013 of the European Parliament

Dear members, please note that the EU has updated it’s list of common customs tariffs which have been suspended for imports into the EU. This includes chemicals and components used in electronics etc. Council Regulation (EU) 2025/2605 of 12 December 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation…
Ben Kemp
January 12, 2026
CELEX:32025R2645: Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance) European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025R2645: Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance)

Dear members, for your information. New EU legislation that allows the ability for compulsory licensing of Intellectual property during a crisis. Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance) View article...
Ben Kemp
January 12, 2026
EU IVDR MDCG 2025-10 – Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU IVDR MDCG 2025-10 – Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices

Dear members, please see new Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices MDCG 2025-10. The guidance was developed in co-operation with the MedTech Europe PMS and Vigilance Working group. The European Commission has recently published a new Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices (MDCG 2025–10).…
Ben Kemp
January 12, 2026
UK Health Security Agency Update (WC 5th January) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK Health Security Agency Update (WC 5th January)

GP out-of-hours syndromic surveillance: weekly bulletins for 2025 Page summary: The number of people contacting their GPs outside of surgery hours under the syndromic surveillance system. Change made: Added week 52 bulletin. Time updated: 9:00am, 2 January 2026 National ambulance syndromic surveillance: weekly bulletins 2025 Page summary: The number of people calling ambulances each day, with results published every week…
Ben Kemp
January 12, 2026