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Ben Kemp

MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For review by 21 January: Weekly ECHA Substance Evaluations

Dear members, please see below list of chemicals flagged as under review for EU CLP by ECHA. MedTech Europe have highlighted the chemicals in yellow as potentially being found in MD/IVDs. Please let me know at regulatory@bivda.org.uk if any of these impact your products. CLP Intention to harmonise classification and labelling – link here:   Pyroxsulam (EC -, CAS 422556-08-9) Proposal…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: GB active substance renewal submission deadlines

Upcoming GB active substance renewal submission deadlines Apply for active substance renewal by the relevant deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming up for the following active…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Registration is now open for the Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices webinar

Dear Colleagues, We are delighted to invite you to the Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices webinar on Tuesday, 3 February 2026 from 14:00-15:00 (GMT). During this webinar the MHRA will present guidance and advice to sponsors who are submitting clinical trials with in vitro Diagnostic (IVD) devices. The webinar will be presented in sections including: Clinical Trials with IVDs The…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Upcoming EU active substance expiry dates postponed, approval dates and dossier submission deadline

Upcoming EU active substance approval dates Apply for product authorisation by the deadlines to keep your products on the NI market. The following EU BPR active substance approval dates are coming up: 1 March 2026 silver zinc zeolite (CAS 130328-20-0 EC 603-404-0) in product types 2, 7 and 9 If you supply biocidal products containing these active substances in the…
Ben Kemp
January 15, 2026
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TGA Australia – Proposed amendments relating to transparency of disruptions to supply of medical devices

Dear members, please let me know via regulatory@bivda.org.uk any feedback to the TGA Australia - Proposed amendments relating to transparency of disruptions to supply of medical devices. Consultation closes 20th Feb 2026.   TGA want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices.   Consultation: Improved sharing of information about medical…
Ben Kemp
January 15, 2026
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