Eu Proposals On Medical Devices

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EU proposes delaying medical devices law by four years to …

https://www.reuters.com/world/europe/eu-proposes-delaying-medical-devices-law-by-four-years-prevent-shortages-2022-12-09/

LONDON, Dec 9 (Reuters) - The EU Health Commissioner on Friday proposed delaying the deadline for companies to comply with a new law regulating …

Exclusive: EU to propose delay to medical device law amid supply ...

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-propose-delay-medical-device-law-amid-supply-worries-2022-12-08/

LONDON, Dec 8 (Reuters) - The EU Health Commissioner will on Friday propose extending the deadline for companies to comply with a new law regulating …

provisions for certain medical devices and in vitro diagnostic …

https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf

The proposed EU action is necessary to avert the risk of shortages of medical devices across the EU. The proposed amendments aim to ensure that the intended purpose of …

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 …

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 · Vollebregt added that the European Parliament may also want to call on the EU Commission to adopt additional legislation to fix problems that persist in the device …

European Commission proposes significant …

https://www.insideeulifesciences.com/2023/01/09/european-commission-proposes-significant-changes-to-transition-timelines-of-the-medical-device-regulation-and-ivd-regulation/

The main elements addressed in the proposal are: For medical devices approved under the Medical Devices Directive 93/42/EEC (MDD) or the Active …

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 ...

Medical devices transitional period - mdlaw.eu

https://mdlaw.eu/mdr/european-parliament-accepts-extension-of-legacy-period-medical-devices/

This Proposal, adopted in January 2023, foresees more time to certify medical devicesunder the Regulations on Medical Devices (MDR) and In Vitro …

EU Proposal to Extend Legacy Medical Device Transition

https://www.reedtech.com/knowledge-center/eu-proposal-to-extend-legacy-medical-device-transition/

In response, on December 9, 2022, the European Commission (EC) proposed and the European Council expressed agreement to a PROPOSAL to extend the …

EU To Extend the Transitional Period of the Proposal Put Forth …

https://www.medicaltechoutlook.com/news/eu-to-extend-the-transitional-period-of-the-proposal-put-forth-into-mdr--nwid-2619.html

The European Commission has petitioned a new proposal and an extension in its transitional period concerning the Medical Devices Regulation. …

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