The NIHR’s Research Delivery Network (RDN) launched on 1 October and marks a new chapter in the optimisation and delivery of health and care research in England. The RDN is a new organisation which has been set up to respond to the changing requirements of the health and care research system. Having taken over from the NIHR Clinical Research Network, the RDN…
Ben KempOctober 16, 2024
Update from MTE Chemicals WG. If any members are impacted they need to let use know. Dear members, I hope this email finds you well. We would like to follow up with you on a few substances on which members were recently consulted on and inform you of the outcomes: Octamethyltrisiloxane (EC 203-497-4, CAS 107-51-7): On…
Ben KempOctober 16, 2024
Packaging waste management is a mounting issue in Asia-Pacific, with governments across the region exploring ways to reduce waste and create a more circular economy. This has led many countries to initiate the development of extended producer responsibility (EPR) frameworks, with a particular focus on packaging and container waste. Our Packaging EPR in Asia Workshop in Bangkok, Thailand (and streaming…
Ben KempOctober 16, 2024
FDA added three standards to the US Consensus Standards list in September for sterility. Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standards Developing Organization Standard Designation Number and Date Standard Title (click for recognition information) 09/09/2024 Sterility 14-460 Complete ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part…
Ben KempOctober 16, 2024
Brings UK legislation into line with EU legislation but then adds the additional new chemicals to the list, ahead of the EU updated legislation. Does not allow Dechlorane Plus or UV328 for IVD or for spare parts. The Persistent Organic Pollutants (Amendment) Regulations 2024 (legislation.gov.uk)
Ben KempOctober 16, 2024
FDA updates QMSR Final Rule to address missing definition of ‘Batch or Lot’ in 820.3 which was missing from the Feb 2024 final QMSR rule. Find out more here.
Ben KempOctober 16, 2024
Update from EU Packaging trade association EUROPEN on the EU Packaging and Packaging Waste Regulation. Note that MedTech Europe advocacy has managed to get IVDs a time limited derogation for contact sensitive packaging regarding minimum recycled content. Find out more here.
Ben KempOctober 16, 2024
Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance. This edition of the document was corrected in February 2024. Read the correction notices by accessing the link above, and learn more about our correction process here. Find out more here.
Ben KempOctober 16, 2024
As the intersection of healthcare and cybersecurity continues to play a vital role in safeguarding patient data and the integrity of medical technologies, it is crucial for professionals in the healthcare sector to stay well-informed about legislative directives such as Section 524B. Are you a professional involved in medical software development and medical technology device manufacturing? Then this on-demand webinar…
Ben KempOctober 16, 2024