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European Commission Updates Regulatory Affairs Newsletter

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Text with EEA relevance)

Dear members, please see here the recast of the EU Liability for defective products directive – 2024/2853. Please note that IVDs are in scope as is software (except software which is provided free or open source, or provided outside of commercial activity). The directive applies from 9th Dec 2026. (Directive (EU) 2024/2853 of the European Parliament and of the Council…
Ben Kemp
November 26, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Video recording – Webinar “Health at a Glance: Europe 2024” (18 November 2024)

This #EUHPP Live webinar on “Health at a Glance: Europe 2024 Promoting healthy ageing and longevity whilst tackling health workforce shortages ! took place online on Monday 18 November , from 14.00 - 15.30 CET, Brussels time. The presentations are available: on the EU Health Policy Platform – Agora network. To access, please register first (use/create your EU login) Once your request of access has been…
Ben Kemp
November 25, 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
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

SKUL Slovakia – Update on IVDR transition

Due to the enormous increase in the number of submitted applications and the extension of processing times, the ZP Section recommends: Not to submit a notice of ZP, which is not subject to the notification obligation pursuant to Act 362/2011, §110 b, par. 2, i.e. not to submit a notification on the availability of Class I medical devices and Class…
Ben Kemp
October 1, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

European Artificial Intelligence Act

Medical device timelines and penalties The EU Artificial Intelligence Act (AIA) was approved on May 21, 2024. The AIA establishes requirements for compliance with AI systems and general-purpose AI (GPAI) models made available or used on the EU market. Stay ahead in the ever-evolving landscape of medical device regulations with our latest updates: AIA regulatory update 1 Scope, classification, conformity…
Ben Kemp
September 25, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Technology Assessment: Commission publishes new guidance on validity of clinical studies

The Commission has published a guidance document on the validity of clinical studies for joint clinical assessments under the EU Health Technology Assessment Regulation, adopted by the Member State Coordination Group. This guidance helps to define, classify, and assess the certainty of clinical study results in an objective, reproducible and transparent way. It covers the analysis of data from different types…
Ben Kemp
September 25, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New Schengen entry requirements (planned for November 2024 onwards)

From November 2024, the new EU Entry/Exit System (EES) will start for all non-EU nationals, including British nationals, travelling in or out of the Schengen area. The Schengen area is made up of 29 European countries, 25 of which are EU Member States. The EES is a digital border system which registers non-EU visitors travelling into the Schengen area instead…
Ben Kemp
September 11, 2024
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