European Medical Directive 2023

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New Regulations - Public Health

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. Two new regulations … See more

Clinical Trials Regulation | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation

European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU …

Medical Devices - New regulations - Public Health

https://health.ec.europa.eu/medical-devices-new-regulations_en

The EU has revised the legal framework of 3 directives to reflect progress over the last 20 years. Getting ready Manufacturer IVD Manufacturers MD Manufacturers …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

Public health support – EU action

https://european-union.europa.eu/priorities-and-actions/actions-topic/health_en

Health Supporting public health in Europe The EU complements national health policies by supporting local EU governments to achieve common objectives, pool …

Scientific guidelines | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines

The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European …

Directives - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives_en

Harmonised European standards under the medical devices Directives are developed by CEN and Cenelec as European standardisation organisations, on the basis of specific …

The Impact of the NIS2 Directive and the CER Directive for …

https://www.twobirds.com/en/insights/2023/ireland/the-impact-of-the-nis2-directive-and-the-cer-directive

Feb 17 2023 Written By Deirdre Kilroy Georgina Parkinson The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased …

EUR-Lex - 32006R2023 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. It shall apply from 1 August 2008. This …

New Product Liability Directive [EU Legislation in Progress]

https://epthinktank.eu/2023/02/13/new-product-liability-directive-eu-legislation-in-progress/

Versions. February 2023: New Product Liability Directive (1st edition) Proposal for a directive of the European parliament and of the Council on liability for …

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