Publication of GB MCL technical reports
An updated copy for BIVDA members can be found here.
Ben KempJuly 10, 2025
Register medical devices to place on the market
Register medical devices to place on the market Page summary: How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland. Change made: Increase to statutory fee effective 16 July 2025. Time updated: 1:59pm, 3 July 2025
Ben KempJuly 10, 2025
APHA – Border Trade Newsletter – getting it right at the border 03 07 25
Getting it right at the border This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: PHES maintenance Lumpy skin disease in Italy and France Authorised Operator Status (AOS) Pilot FMD…
Ben KempJuly 10, 2025
China – standards update for medical devices including IVDs
NMPA China have published a list of updated Medical Device Standards including some for IVDs including: 15 - 17α-Hydroxyprogesterone Assay Kit (Labelled Immunoassay) 17 - Information provided by the manufacturer of the medical device 18 - Motor Neuron Survival Gene (SMN) Assay Kit 19 - Aldosterone Assay Kit (Chemiluminescence Immunoassay) 20 - Colorectal Cancer-relate d Gene Methylation Detection Kit (Fluorescent…
Ben KempJuly 10, 2025
EUDAMED User Guide – UDI Devices Production V2.15 2025
You can find the updated user guide here.
Ben KempJuly 10, 2025
FDA Guidance Q&A – Conducting Remote Regulatory Assessments 202506
You can find the new guidance here.
Ben KempJuly 10, 2025
Borderline products: medical devices and other products
You can find the updated MHRA guidance here.
Ben KempJuly 10, 2025
For information: EP report on the implementation of the EU chemicals strategy for sustainability
MedTech Europe would like to share with you a summary of the European Parliament’s recently published ‘Targeted scrutiny of the EU chemicals strategy for sustainability’. Background The EU chemicals strategy for sustainability (CSS), introduced in 2020 as part of the European Green Deal, sets out 85 actions to curb chemical pollution, safeguard human and environmental health, and boost innovation and competitiveness…
Ben KempJuly 10, 2025
TGA Guidance on Change of Sponsor of a therapeutic good
This guidance has been updated by the Australian Government and can be found here.
Ben KempJuly 10, 2025