Skip to main content
search
Category

Regulatory Affairs Newsletter Archive

MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Class D – press release Notified Bodies

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 Kemp
October 9, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Action needed now if you use EPO online filing!

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 Kemp
October 8, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 30 Sept)

Clinical investigations guidance Page summary: Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Updated section on ‘Amendments’ to reflect changes to the process. Time updated: 9:34am, 26 September 2024 Access Consortium: joint pipeline meetings Page summary: The Access Consortium is offering joint pipeline meetings to pharmaceutical and…
Ben Kemp
October 2, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Update (WC 30 Sept)

Persistent organic pollutants (POPs) Page summary: Information relating to persistent organic pollutants (POPs). Change made: Added link to a guide on ‘When electrical and electronic equipment (EEE) becomes waste (WEEE)’. Time updated: 10:55am, 25 September 2024 Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved…
Ben Kemp
October 2, 2024
Close Menu