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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

EU Proposed Common Specifications update

Please see the proposed update and introduction of new Common Specifications for Class D devices under the EU IVD Regulation. Please let us know if you have any feedback on the proposals. Note that the consultation close 16th September, so BIVDA will require feedback by Close of Business 13th September. Remember that these will apply in Northern Ireland, and MHRA…
Ben Kemp
August 27, 2024
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Common specifications for IVDs for parasites, viruses proposed by European Commission

The European Commission has suggested revising the common specifications for certain class D in vitro diagnostic devices to address tests for specific parasites and viruses of public health importance. Stakeholders have a four-week period to provide feedback on these proposed changes. On 19 August, the Commission released the proposed amendments, which, if approved, would update the In Vitro Diagnostic Medical…
Ben Kemp
August 27, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU standard – Radio Equipment – Internet

EN 18031-1:2024 - Common security requirements for radio equipment - Part 1: Internet connected radio equipment (publication date=2024-08-14) View article... EN 18031-2:2024 - Common security requirements for radio equipment - Part 2: radio equipment processing data, namely Internet connected radio equipment, childcare radio equipment, toys radio equipment and wearable radio equipment (publication date=2024-08-14) View article... These have been adopted as…
Ben Kemp
August 21, 2024
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Cyber security in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings

This study reveals cyber vulnerabilities in the EU healthcare sector and further highlights the challenge of characterising cyber incidents in regard to their health consequences. Hurdles are a lack of consistent evaluation and reporting criteria and a lack of frameworks for assessing causality. We alert that such tools need to be developed in order to prepare for the rising risk…
Ben Kemp
August 21, 2024
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EU: Council decision on AI, Human Rights, Democracy and the Rule of Law

Please see the EU Proposal for a COUNCIL DECISION on the signing, on behalf of the European Union, of the Council of Europe Framework Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law. Note that that the UK is a Council of Europe member state.
Ben Kemp
August 20, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

(EU) 2024/2120 published

"(EU) 2024/2120 - renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices" published. This reestablishes the following four entities as UDI issuing entities. GSI HIBCC ICCBBA IFA
Ben Kemp
August 14, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

17 Oct deadline for member states to implement EU Directive 2022/2555

17th October 2024 is the deadline for EU member states to implement the EU Directive 2022/2555 EUR-Lex - 02022L2555-20221227 - EN - EUR-Lex (europa.eu) on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) 910/214 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive). NIS 2 widens the scope of services covered…
Ben Kemp
August 14, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Corrigendum to Regulation (EU) 2024/1781

You can read the Corrigendum to Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024) here.
Ben Kemp
August 14, 2024
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