TGA Guidance - Understanding your post-market responsibilities for medical devices - Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices. View article...
adminMarch 19, 2026
Updated electrical safety standard EN IEC 60445:2021/A1:2026 - Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors (publication date=2026-03-13) View article...
adminMarch 19, 2026
Brazil’s Medical Device Regulatory Landscape in 2026 Thursday, April 2, 2026 | 11:00 AM – 12:00 PM (Austin Texas, U.S.) This webinar will provide an essential update on Brazil’s evolving regulatory landscape, covering key changes taking effect in 2025 and what manufacturers should expect moving into 2026. Attendees will gain practical insights informed by Emergo by UL’s market entry and…
adminMarch 19, 2026
As part of BIVDA member the National Measurement Laboratory's (NML) commitment to delivering world-leading measurement science for an evolving future, they are excited to share their new website! Designed to showcase NML's scientific expertise and make it easier for partners and stakeholder to engage, the new website offers: Insights into NML's research and impact Opportunities to explore programmes, networks, partnerships and training courses Access to their…
adminMarch 19, 2026
Now is your opportunity to vote for BIVDA's new board members for 2026, who will be announced at our AGM on Wednesday 25th March 2026. We ask members to email ben.kemp@bivda.org.uk with their vote marking their first, second and third preference. Only one vote is allowed per company so please consult with your colleagues before submitting your vote. The closing date is 17:30 on…
adminMarch 18, 2026
Please note this is an extract of the original bulletin. Medical devices: UK approved bodies* Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: Updated ‘DEKRA Certification UK Ltd medical devices scope’. *Note: IVD devices are not in scope Medical devices given exceptional use authorisations during the COVID-19 pandemic…
adminJuly 10, 2024
Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to export to the EU.…
adminJuly 10, 2024
Please note this is an extract of the original bulletin. UK Trade Tariff: duty suspensions and autonomous tariff quotas Page summary: Temporary duty suspensions and autonomous tariff quotas for importing goods into the UK. Change made: Guidance updated to reflect closing of new suspensions window that ran from 8 May 2024 to 3 July 2024. UK-Australia FTA Joint Committee Statement…
adminJuly 10, 2024
On 08 July, the Medical Device Coordination Group (MDCG) published MDCG 2020-16 Rev. 3 guidance on "the classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746". This document provides updates from the previous revision released in February 2023. These include: Addition of ‘kit’ definition Revision of examples for Rule 3(a) and Rule 6 Revision of Rule…
adminJuly 10, 2024