European Union Medical Device Recalls

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Quality defects and recalls | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/quality-defects-recalls

Assessment of reports of product quality defects. Rapid alerts and recalls. This content applies to human and veterinary medicines. The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally …

Best Recall Practices Guidelines — Part 1 — Medical …

https://www.sidley.com/en/insights/publications/2021/02/best-recall-practices-guideline--part-1-medical-devices

As set out in the Regulations, a recall aims to return a device that was already made available to the end user, whereas a withdrawal aims to prevent a device in the supply …

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 …

Market surveillance and vigilance - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en

MDCG 2021- 23 - Public Health

https://health.ec.europa.eu/system/files/2021-08/mdcg_2021-23_en_0.pdf

Medical Devices Medical Device Coordination Group Document MDCG 2021-23 Page 1 of 7 MDCG 2021- 23 Guidance for notified bodies, distributors and importers on certification …

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 …

EUDAMED database - EUDAMED - European Commission

https://ec.europa.eu/tools/eudamed/

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices ( Regulation (EU) 2017/745) and in vitro …

Safety information | International Medical Device …

https://www.imdrf.org/safety-information

Safety information | International Medical Device Regulators Forum Safety information The following table provides links to device safety information as published by IMDRF …

January 2023 Medical Device and IVD News Update | NSF

https://www.nsf.org/news/jan-2023-medical-device-ivd-update

The European Commission published its proposal paper on the transition provisions for medical devices and in vitro diagnostic medical devices on January 6, 2023, it sets out …

European Union: New Transition Timelines In EU And …

https://www.mondaq.com/uk/life-sciences-biotechnology--nanotechnology/1283340/new-transition-timelines-in-eu-and-uk-medical-device-regimes

2 days ago · The European Union Medical Device Regulation (EU MDR) was first enacted in 2017. At the time, the implementation periods looked ambitious but achievable. The …

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