Update Medical Device Directive

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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 repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

CDRH News and Events Medical Device Safety Device Advice Public Health Emergency Updates Stay up to date as we continue to keep up our ongoing mission of protecting …

Medical Devices - Sector - Latest updates - Public Health

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

MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the …

MDR vs. MDD: 13 Key Changes - The FDA Group

https://www.thefdagroup.com/blog/mdr-vs-mdd-13-key-changes

Updated EU-MDR Timeline. Schedule an EU-MDR Gap Assessment and Remediation Consultation. Europe's new Medical Devices Regulation (MDR) will bring …

Harmonised standards - Public Health

https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en

The publications in the OJEU of references of harmonised standards under the medical devices regulations are available: For Regulation (EU) 2017/745 Search for …

The Latest on Medical Device Regulatory …

https://content.intland.com/blog/the-latest-on-medical-device-regulatory-changes-in-2021

Every device used in the UK must register with the MHRA, and every EU company must regularly report to a UK Responsible Person with the performance data for their device. …

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 May 2021. The …

The European Union Medical Device Regulation – …

https://eumdr.com/

The Medical Device Coordination Group (MDCG) approved two further documents clarifying the timelines and requirements for using the EUDAMED database: Document 2019-4 …

Medical Devices Directive 93/42/EEC is …

https://www.cti-cem.com/blog/medical-devices-directive-93-42-eec/

This directive includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or …

New UK MHRA Medical Devices Regulations Published - NAMSA

https://namsa.com/uk-mhra-medical-device-regulations-published/

Transitional arrangements devices that are CE marked under the EU Medical Devices Regulation (MDR 2017/745): This transitional arrangement for medical devices …

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