Regulatory Newsletter

Welcome to BIVDA’s weekly summary of regulation and environmental topics.
Click on each topic below to get more information or read through our summary as a quick snapshot.
For any queries or additional advice on regulatory or environmental, you can contact Ashleigh.


November 18, 2022 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Latest UKCA extensions do not apply to medical devices

This includes: The General Product Safety Regulations 2005 Supply of Machinery (Safety) Regulations 2008 Electromagnetic Compatibility Regulations 2016 Pressure Equipment Safety Regulations 2016 Electrical Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Radio Equipment Regulations 2017 These timelines have been extended for 12 months to allow extra time for compliance. Importantly, these timeline changes do not impact medical…
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Regulations: ecodesign of energy-consuming products – Regulatory Affairs Newsletter #1

Guidance for manufacturers, their authorised representatives and importers. Change made: Declaration of Conformity template added. Other pages commonly used European Commission updates MedTech Europe updates HSE eBulletins UKRI updates Home Office updates Office for Life Sciences bulletin Cabinet Office weekly update (extract of original bulletin) Environmental Agency weekly update (extract of original bulletin) MDCG updates Could consider Upcoming regulatory or…
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