The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 16 November These include updates on news, including regulatory updates, transitional guidance and events.
adminNovember 17, 2023
The TGA is in the process of establishing the Australian Unique Device Identification Database (AusUDID). The TGA is hosting a webinar to provide an update on the Australian UDI implementation and a presentation on learnings and the real-world benefits of the UDI adoption in the US healthcare system. The webinar is held on 21 November from 11:30am to 12:30pm (AEDT).…
adminNovember 17, 2023
ECHA has published their latest weekly update (15 November). Due to changes in the structure of ECHA's updates, we can no longer link to updates themselves. To ensure BIVDA members continue to receive this information, we have opted to provide the full ECHA notification. ECHA identifies research needs for regulating hazardous chemicals We have published a new report on…
adminNovember 17, 2023
Please note this is an extract of the original bulletin. Energy Savings Opportunity Scheme (ESOS) Page summary: Find out if you qualify for ESOS and how to comply. Change made: Guidance updated to reflect the changes for Phase 3.
adminNovember 17, 2023
DEFRA have provided the following information on closed loop recycling, further to the consultation on draft producer responsibility obligations: Following our consultation on the draft producer responsibility obligations (packaging and packaging waste) regulations, we have received feedback from several stakeholders that we consider a provision to allow producers operating ‘closed loop’ recycling systems to offset against their household disposal fees…
adminNovember 17, 2023
Developments in the use of new technologies, e.g., induction hobs and wireless charging, require updates to the assessment of how exposure to electromagnetic fields might impact our health, as well as the scientific guidelines that underpin restrictions and reference levels. In October 2023, following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER)…
adminNovember 17, 2023
Please note this is an extract of the original bulletin. Mandatory digital customs requirements: parcels to Ireland Page summary: This guidance is for businesses looking to send parcels to Ireland from the UK using Royal Mail, Parcel Force and the UK’s nationwide network of Post Offices. Change made: First published. Government slashes up to £1bn a year of business burdens…
adminNovember 17, 2023
In follow up to the plenary discussions in December 2022, ISO/TC 210 (AAMI QM, Quality management and corresponding general aspects for products with a health purpose including medical devices) Working Group has begun preparatory work on items for future revision of ISO 13485:2016. The technical committee have launched a survey seeking feedback on the use of the standard for regulatory…
adminNovember 17, 2023
MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…
adminNovember 17, 2023
Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) is the meeting of the EU Ministers of Health. The upcoming EPSCO meeting agenda includes the implementation of IVDR and MDR with information from the French delegation, supported by the Belgian, German, Irish and Italian delegations. EPSCO is the meeting of the EU Ministers of Health. A public debate is proposed.…
adminNovember 17, 2023