To: Class D WG and Regulatory Affairs IVD Committee Dear members, Regarding Class D devices under EURLs, please note to the recent press release from the TEAM-NB (Notified Bodies’ association) accessible via the following link. The press release confirms Notified Bodies’ positive reception of the newly revised MDCG 2021-4 guidance and provides reassurance that the batch testing process will continue…
Ben KempOctober 9, 2024
The EPO has modernised access to eOLF. You will need to make changes to continue signing and sending your UK patents using eOLF. As of the 1 October 2024 you are no longer able to renew eOLF Smart Cards that have expired. To continue filing with the IPO via eOLF, you will need to replace your smart card with a…
Ben KempOctober 8, 2024
This week, the MHRA have launched their business plan for the next year, with a focus on enabling access to groundbreaking new technology. The plan has identified four strategic priorities which will dictate the plan's successful delivery: Maintain public trust through transparency and proactive communication, including working to address health inequalities Enable healthcare access to safe and effective medical products…
Ben KempOctober 8, 2024