FDA have updated the MUDUFA Small Business request form ( Form FDA 3602N ) used to claim lower or waived user fees.
Ben KempAugust 28, 2025
Critical Communication (EU) 2024/1860 – IVDR 26 September 2025 deadline approaching & impact on legacy devices not transitioning to the IVDR IVDD certified devices and Class D self-declared devices manufacturers to sign the written agreement with a Notified Body On 9 July 2024, the Regulation (EU) 2024/1860 amending the MDR and IVDR was published in the Official Journal of the…
Ben KempAugust 28, 2025
Please see the two updated FDA Guidance documents from June 2025: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA Unique Device Identifier Requirements for Combination Products | FDA
Ben KempAugust 28, 2025
Dear members, please see below update regarding submission for EU RoHS Annex III exemption packs 4(a)-I and 4(f)-IV regarding lamps, specifically mercury containing lamps used because they emit light in the UV wavelengths. The joint submissions have been made under the Umbrella project and via Lighting Europe. These will also apply in Northern Ireland. Please note that members interested in…
Ben KempAugust 28, 2025
Dear members, please be advised that the following standard regarding full material declarations has been published. Derived from the existing IEC standard BS EN IEC 62474:2019+A1:2021 | 31 Jan 2021 | BSI Knowledge for full material declarations for products of and for the electrotechnical industry. BS EN IEC 82474-1:2025 | 31 Jul 2025 | BSI Knowledge The standard provides a…
Ben KempAugust 28, 2025
Qserve perspective on the new Australian TGA UDI requirements. Increasingly relevant as Australia is one of the countries MHRA have identified from international recognition under the proposals for the Pre-Market SI. *Please note, the above post on TGA UDI requirements shows the timelines table for medical devices rather than the IVD table as below. TGA UDI Timelines for IVDs…
Ben KempAugust 28, 2025
AI to cut paperwork to free up doctors’ time for patients Page summary: Patients and frontline staff could see huge benefits from new AI helping people out of hospital quicker and slashing bureaucracy. Change made: First published. Time updated: 10:30pm, 16 August 2025 AI Exemplars programme Page summary: AI Exemplars are transforming public services – improving healthcare, education, planning and…
Ben KempAugust 28, 2025
Extended producer responsibility for packaging: templates for sampling and inspection plans Page summary: If you are required to apply for registration as a reprocessor or exporter of packaging waste under extended producer responsibility (EPR) for packaging, and to apply for optional accreditation, you must submit a sampling and inspection plan using these templates. Change made: This adds the overseas reprocessing…
Ben KempAugust 28, 2025
Ceri Morgan Appointed Trade Commissioner for Europe Page summary: Ceri Morgan Appointed as His Majesty’s Trade Commissioner for Europe Change made: First published. Time updated: 12:01am, 18 August 2025 Northern Ireland science and tech industries boosted by over £30 million from UK Industrial Strategy Page summary: Major win for Northern Ireland’s high-tech sectors from the UK’s modern Industrial Strategy, supporting…
Ben KempAugust 28, 2025
Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated the list of professionals who can certify export health certificates in England and Scotland. Time updated: 12:09pm, 20 August 2025 Animal…
Ben KempAugust 28, 2025