Skip to main content
search
All Posts By

Ben Kemp

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Stay Compliant with New IVD Regulations

Wednesday, Oct,16th , 2024 | 9:00 AM – 9:45 AM (Austin Texas, U.S.) Join Heather Crawford from the Emergo by UL’s team, live on Oct. 16, 2024 from 9-9:45 a.m. CST as she discusses Regulation (EU) 2024/1860. What has changed with the adoption of Regulation (EU) 2024/1860, and how can you determine whether you are eligible for the extension under…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Radio Equipment (Amendment) (Northern Ireland) Regulations 2024

The Radio Equipment (Amendment) (Northern Ireland) Regulations 2024 (legislation.gov.uk) The Windsor Framework requires that the European Union (“EU”) legislation listed in its Annex 2 is implemented in Northern Ireland. One of the Directives listed in Annex 2 is Directive 2014/53/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to…
Ben Kemp
October 15, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Brazil IVD News: Regulation updates

To help you navigate the Brazilian Health Regulatory Agency's (ANVISA) latest updates for in vitro diagnostics (IVDs) and the implications for your healthcare products, we highly recommend you review this detailed report by Patricia Urakawa, Senior Consultant of Regulatory Affairs at Emergo by UL. This invaluable resource explains several critical updates to RDC 830/2023 that you should be aware of,…
Ben Kemp
October 15, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32024D2657: Council Decision (EU) 2024/2657

Two new harmonised standards have been added for IVD under the EU IVD regulation. In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added: No ‘14. Reference of the standard EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) No ‘15. EN ISO 20916:2024 In vitro diagnostic medical devices –…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

EPO free online event

Patents and innovation in European universities The IPO UK has contributed to a European Patent Office (EPO) “Patents and innovation in European universities” study. On the 22 October the EPO’s Observatory on Patents and Technology will be hosting an online event on technology transfer and academic innovation in Europe, to mark its first anniversary. This event brings together key stakeholders…
Ben Kemp
October 15, 2024
Close Menu