European Commission Counterfeit Medical Devices

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Overview - Public Health

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

Documents. Health and safety: Counterfeit medical devices can have adverse effects, including potentially lethal consequences, as they are often non-sterile, of poor quality, contain inappropriate materials and be of questionable effectiveness. Economic: Counterfeit medical devices distort competition, … See more

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

Council of Europe Convention on the counterfeiting of …

https://www.coe.int/en/web/impact-convention-human-rights/council-of-europe-convention-on-the-counterfeiting-of-medical-products-and-similar-crimes-involving-threats-to-public-health

the manufacturing of counterfeit medical products; supplying, offering to supply and trafficking in counterfeit medical products; the falsification of documents; the …

Council of Europe Convention on the Counterfeiting of …

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

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 …

Falsified medicines: overview | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/falsified-medicines-overview

The European Union (EU) has a strong legal framework for the licensing, manufacturing and distribution of medicines, centred around the Directive on falsified medicines for human use, so that only licensed pharmacies …

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 …

Global operation sees a rise in fake medical products

https://www.interpol.int/en/News-and-Events/News/2020/Global-operation-sees-a-rise-in-fake-medical-products-related-to-COVID-19

LYON, France – Counterfeit facemasks, substandard hand sanitizers and unauthorized antiviral medication were all seized under Operation Pangea XIII, which saw police, customs and health regulatory …

Public Health: medical devices - ec.europa.eu

https://ec.europa.eu/commission/presscorner/detail/en/ip_23_23/smo

Public health: more time to certify medical devices to mitigate risks of shortages. Highlights, press releases and speeches ...

European Parliament votes to extend MDR transition period

https://www.raps.org/news-and-articles/news-articles/2023/2/european-parliament-votes-to-extend-mdr-transition

2 days ago · The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving …

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