European Commission Medical Devices Proposal

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Press corner | European Commission

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

The Medical Devices Regulation has been applicable since 26 May 2021. It provides for a transition period until 26 May 2024. At the EPSCO Council on 9 December 2022, EU …

provisions for certain medical devices and in vitro diagnostic …

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

European Parliament and of the Council establish a reinforced regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high …

Medical Devices - Sector - Public Health

https://health.ec.europa.eu/medical-devices-sector_en

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices The UDI Helpdesk helps economic operators in …

European Commission Proposes Amending Transitional …

https://www.cooley.com/news/insight/2023/2023-01-10-european-commission-proposes-amending-transitional-provisions

On 6 January 2023, the European Commission adopted a proposal to amend the transitional provisions of Regulation (EU) 2017/745 on medical devices …

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 …

European Commission Proposes Extending Transition …

https://www.cooley.com/news/insight/2022/2022-12-14-european-commission-proposes-extending-transition-period-in-medical-devices-regulation

The European Commission proposes to extend the transition period currently foreseen in the MDR for devices certified in accordance with the Medical …

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 proposal obviously gives the medical device industry more time to transfer their devices from MDD (and AIMDD) to the MDR. This also reduces the …

European Commission proposes extension of Medical Devices …

https://boydconsultants.com/european-commission-proposes-extension-of-mdr-transition-periods-in-a-bid-to-prevent-medical-device-shortages/

The proposal will be formally tabled before the European Parliament and the Council of Europe in January 2023 and, if approved, will help alleviate the challenges …

EU commission moves forward with proposal to delay MDR …

https://biotech-today.com/eu-commission-moves-forward-with-proposal-to-delay-mdr-implementation/

The European Commission adopted a proposal Friday to delay the full implementation of the new Medical Device Regulation, or MDR. According to the …

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