Please see an update which supports the provision of electronic user manuals for electronic products here.
Ben KempSeptember 4, 2024
BIVDA and MedTech Europe are gathering information on the EU RoHS (including Northern Ireland), exemption pack renewal for Lead and Mercury in product type 8 – medical devices include those specifically for IVDs. If you rely on the exemption packs for RoHS compliance to place products on the EU and/or Northern Ireland markets, then please let BIVDA know. MedTech Europe…
Ben KempSeptember 3, 2024
The MHRA last week launched a consultation on statutory fees proposals for April 2025 until March 2027. Unsurprisingly, the trajectory is upwards - in some cases (such as clinical trials) significantly. BIVDA’s Head of Policy and Programmes, Paul Fisher noted, "These proposed increases will disproportionately impact SMEs - the sector that the government and NHS recognise as a key part…
Ben KempSeptember 3, 2024
This webinar comprises of three following presentations of 20 min each followed by 20 min of panel discussion at the end. Chair: Dr. Raul Girardi Talk 1- "State of the art" - Dr. Jorge Morancho Zaragoza Talk 2- "Algorithm for obtaining consensual minimum quality specifications" - Dr. Angel Manuel Salas García Talk 3- "State of the Art Charts" - Dr. Enrique Prada de Medio…
Ben KempAugust 28, 2024
What will participants gain? A better understanding of the regulatory systems in both the EU and UK The role BSI as a Notified/Approved Body plays in ensuring patient safety How patients and medical professionals can play their part in supporting safe and effective devices on the market Who should attend? Anyone who wishes to learn more about BSI and its role…
Ben KempAugust 28, 2024
DCMS Sectors Economic Estimates Page summary: This series brings together all documents relating to DCMS Sectors Economic Estimates. Change made: Added latest monthly GVA publication. Time updated: 9:30am, 20 August 2024 UK innovation diffusion and adoption survey Page summary: The Department of Science Innovation and Technology (DSIT) is conducting a survey of UK businesses. Help us understand how we can…
Ben KempAugust 28, 2024
Get someone to deal with customs for you Page summary: Find out how you can hire a person or business to deal with customs for you. Change made: Guidance updated to make it clear you will still be responsible for due diligence for your customs declarations if you appoint someone to deal with customs for you. Time updated: 2:01pm, 21…
Ben KempAugust 28, 2024
General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Updated 2 licences:- General licence to import certain products for in vitro use with 10% or less animal by-product carrier or stabilizer…
Ben KempAugust 28, 2024
Shingles vaccination: guidance for healthcare practitioners Page summary: Information about the shingles vaccination programme aimed at healthcare practitioners. Change made: Clarifications made in the 2 sections about severely immunosuppressed individuals who received Zostavax prior to becoming immunosuppressed. Time updated: 9:30am, 23 August 2024 Smallpox vaccine PGD template Page summary: PGD template for administering smallpox vaccine in response to mpox (monkeypox).…
Ben KempAugust 28, 2024
Our governance Page summary: The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA). Change made: Added registration information for next meeting to be held on Tuesday 17 September 2024 Time updated: 10:17am, 23 August 2024 AI Airlock: the regulatory sandbox for AIaMD Page summary: A proactive, collaborative, agile and the first of its…
Ben KempAugust 28, 2024