European Medical Device Regulations

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Medical devices | European Medicines Agency

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

Jan 25, 2023

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 …

New Regulations - Public Health

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

The European Union Medical Device Regulation – …

https://eumdr.com/

The EU Commission published three new Factsheets describing the implications of the new Regulations on various stakeholders: (1) Factsheet for Authorised Representatives, …

Medical Devices - New regulations - Latest updates

https://health.ec.europa.eu/medical-devices-new-regulations/latest-updates_en

Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023. Update - …

Device makers gain more time to adapt to Europe’s MDR after …

https://www.medtechdive.com/news/EU-European-Parliament-MDR-extension/643064/

1 day ago · The European Parliament on Thursday voted overwhelmingly to delay implementation of the new Medical Device Regulation, or MDR. The 537-3 vote gives …

A Comprehensive Guide to EU MDR (EU Medical Device …

https://content.intland.com/blog/a-comprehensive-guide-to-eu-mdr-eu-medical-device-regulation

Medical device regulation in Europe Until 2021, medical devices in the European market were regulated by the Medical Devices Directive (MDD). First …

New European MDCG Guidance on Medical Device Vigilance …

https://www.emergobyul.com/news/new-european-mdcg-guidance-medical-device-vigilance-requirements

The long-awaited Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website. MDCG 2023-3, …

European Medical Device Regulation | Deloitte Netherlands

https://www2.deloitte.com/nl/nl/pages/risk/articles/european-medical-device-regulation.html

The European Medical Device Regulation 2017/745 (EU-MDR) provides a regulatory framework with the purpose of ensuring safe and effective performance of medical …

Guidance – The European Union Medical Device …

https://eumdr.com/guidance/

Guidance – The European Union Medical Device Regulation Guidance The Medical Device Coordination Group (MDCG) of experts have published guidance on a range of …

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