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Regulatory Affairs Newsletter Archive

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Technology Assessment: New Opportunity to Apply for Joint Scientific Consultations

Please see the below information regarding EU joint Health Technology Assessment, with particular focus on joint Pharma, MD/IVD scientific advice meetings, for joint clinical assessments. Health Technology Assessment: New Opportunity to Apply for Joint Scientific Consultations Today, the Commission has opened the first submission period for joint scientific consultations (JSCs) for 2026. This is the third submission period under the EU Health…
Ben Kemp
January 12, 2026
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Townhall meeting 14/01/2026

FDA Town Hall event 14th Jan for members exporting to or using FDA Conformity. The webinar will cover design and risk and some of the FAQ aspects raised by the change from the previous QSR requirements to the new QMSR ISO 13485 based requirements. Town Hall – Quality Management System Regulation: Risk and Design and Development - 01/14/2026 | FDA
Ben Kemp
January 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Medical Devices (Fees Amendment) Regulations 2026

Dear members, The Medical Devices (Fees Amendment) Regulations 2026 was laid before parliament on the 16th December, and is now  subject to parliamentary process. The draft legislation confirms the move to the annual fee, which is initially set to be £300.00, and it confirms the adoption of GMDN level 2 or level 1 (where there is no relevant level 2…
Ben Kemp
January 12, 2026
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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
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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
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 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
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
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
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