Medical Devices Regulations Europe

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Medical devices | European Medicines Agency

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

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 …

New Regulations - Public Health

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

Medical Devices - New regulations - Public Health

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

An official website of the European Union Public Health Home Medical Devices - New regulations Medical Devices - New regulations Overview The EU has …

The European Union Medical Device Regulation – …

https://eumdr.com/

The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices …

Medical Devices - New regulations - Latest updates

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

European Medical Device Nomenclature (EMDN) - Questions and Answers News announcement 26 May 2021 Stronger rules on medical devices News …

Guidance - MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) Search for available translations of the …

Medical Devices - Sector - Public Health

https://health.ec.europa.eu/medical-devices-sector_en

The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New …

EU Medical Device Regulations | CMS MedTech

https://cmsmedtech.com/eu-medical-device-regulations/

The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that …

Manufacturers – The European Union Medical Device …

https://eumdr.com/manufacturers/

There is no single formula however, and the described approach will likely require adjusting to the specifics of the manufacturer and device concerned. Step 1: Decide the intended …

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