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Ben Kemp

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

EU – Update – Harmonised Standards list updates

Dear Members, please see below the update that ISO 17665:2024 and ISO 18113:2024 series have been added to the list of EU IVDR harmonised standards. OJ:L_202600197:EN:TXT.pdf Mario Gabrielli Cossellu • 1st 📣 Two new Commission Implementing Decisions on references of #Harmonised #Standards in support of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR) have been adopted on 28 January…
Ben Kemp
February 6, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EUDAMED VGL module implementation timeline

The published EUDAMED implementation timeline indicates Q2 2027 as the start of the mandatory use of the VGL module (no voluntary use foreseen – see copied below). Please refer to this official source of EUDAMED implementation timelines at the European Commission’s EUDAMED website: https://health.ec.europa.eu/medical-devices-eudamed/overview_en  
Ben Kemp
February 6, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

PIC: Annual reporting of exports and imports

Dear members, PIC (Prior Informed Consent) notification and reporting is regarding cross border movements of certain hazardous chemicals, particularly substances of very high concern. PIC requires such shipments to be agreed with both the originating and destination countries. For some substances the PIC notifications are required at time of shipment, but for some substances and countries prior agreements are in…
Ben Kemp
February 6, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

Dear members, TGA has released their enforcement priorities for 2026-2027, with Direct to consumer IVDs being No. 1 on the list and Software as a Medical Device being No. 7 of the twelve key areas that they intend to focus on. The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The TGA Compliance Principles 2026…
Ben Kemp
February 6, 2026
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