European Medical Device Directive 2010

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EUR-Lex - 32010D0227 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32010D0227

The aim of the European databank for medical devices is to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and authorised representatives, devices and certificates and to vigilance …

Medical devices | European Medicines Agency

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

The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. EMA issued a final guideline on quality documentation …

Medical Devices Directive - Wikipedia

https://en.wikipedia.org/wiki/Medical_Devices_Directive

Directives - Public Health

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

New Regulations - Public Health

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

With effect from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EEC …

MEDICAL DEVICES Guidance document …

https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native

The Medical Devices Directive states in Annex X that as a general rule confirmation of conformity with the requirements concerning the characteristics and performances …

EU Medical Device Directives - 6 Key Elements to Ensure …

https://www.complianceonline.com/resources/eu-medical-device-directives-key-elements.html

EU Medical Device Directives - 6 Key Elements to Ensure Compliance Ensure products fulfill the EU's unique regulatory requirements by understanding key elements that can …

Medical devices - Internal Market, Industry, Entrepreneurship and …

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the …

GUIDELINES ON MEDICAL DEVICES - European …

https://ec.europa.eu/docsroom/documents/10336/attachments/1/translations/en/renditions/pdf

medical device. Clinical Investigation Plan: Document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of …

The European Union Medical Device Regulation – …

https://eumdr.com/

The Medical Device Coordination Group (MDCG), which has many responsibilities in the new Regulation, has now been established. It is listed in the register of Commission …

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