The Office for Life Sciences have published their latest updates. OLS Stakeholder Bulletin - 12 April These include updates on news, including regulatory updates, transitional guidance and events.
adminApril 17, 2024
HSE have published their latest bulletins: Biocides 12 April: Upcoming EU active substance expiry dates Biocidal products must be phased off the NI market The active substance/product type combinations listed below are due to expire under the EU BPR on the following dates. This affects NI: (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin (Warfarin) (CAS 81-81-2 EC 201-377-6) in product type 14 (deadline: 30 June 2024)…
adminApril 17, 2024
ECHA has published their latest weekly update (17 April). Due to changes in the structure of ECHA's updates, we can no longer provide a link to the updates themselves. To ensure BIVDA members continue to receive this information, we have opted to provide the full ECHA notification. Enforcement authorities will check poison centre notifications The transition towards safer and…
adminApril 17, 2024
Directorate-General for Health and Food Safety has published the first revision of MDCG 2022 – 9: “MDCG 2022-9 rev.1 – Summary of safety and performance template”. Members are requested to provide any comments to Regulatory@bivda.org.uk by 30 April.
adminApril 17, 2024
Multiple EU and UK legislative changes have taken place recently. Notably, these include changes to: EU legislations: Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of…
adminApril 17, 2024
Multiple standards have been updated recently. Notably, these include: ISO 9001:2015/Amd 1:2024 Quality management systems — Requirements — Amendment 1: Climate action changes ISO 20658:2023 Requirements for the collection and transport of samples for medical laboratory examinations ISO 35001:2019/Amd 1:2024 Biorisk management for laboratories and other related organizations — Amendment 1: Climate action changes ISO 20688-2:2024 Biotechnology — Nucleic acid…
adminApril 17, 2024
Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added Combined review of a CTIMP and Medical Device section and accompanying guidance Combined IMP Device guidance Borderlines…
adminApril 17, 2024
BSI are looking for experts in the field of electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017), to join their committee EPL/66 in developing the above standard which is undergoing a revision. BIVDA members who may be interested in joining this committee are requested to contact Regulatory@bivda.org.uk.
adminApril 17, 2024
Please note this is an extract of the original bulletin. Taking part in the UK Emissions Trading Scheme markets Page summary: This guidance explains the operation of the UK ETS markets and how to take part in auctions and in trading on the secondary market. Change made: Cost Containment Mechanism figures updated for latest month.
adminApril 10, 2024
Please note this is an extract of the original bulletin. 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: Added Medway Park Veterinary Centre to the list of professionals who can…
adminApril 10, 2024