2022 Medical Devices 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 …

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 on medical …

New Regulations - Public Health

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

EUR-Lex - 32022R0112 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/eli/reg/2022/112/oj/eng

Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was …

2022 Device Approvals | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/recently-approved-devices/2022-device-approvals

2022 Device Approvals. The products listed in this section include some of the newest medical ...

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

The MDR replaces the existing Directives for medical devices ( 93/42/EEC and 90/385/EEC ). The Regulation on in vitro diagnostic medical devices, which also …

The Blue Guide on the implementation of the product rules 2022 …

https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en

The Blue Guide on the implementation of the product rules 2022 is published Today, the Commission published the ‘Blue Guide on the implementation of the product …

Medical Device Directive vs Medical Device Regulation

https://studycorgi.com/medical-device-directive-vs-medical-device-regulation/

The European Commission (EU) has decided that the current European Device Directive, or MDD, on medical devices is not strict enough. It has been …

The Impact of the NIS2 Directive and the CER Directive for …

https://www.twobirds.com/en/insights/2023/ireland/the-impact-of-the-nis2-directive-and-the-cer-directive

In this article we will consider the Network and Information Systems Directive (EU) 2022/0383 (“ NIS2 ”) and the Directive on the Resilience of Critical …

Factsheet: medical devices overview

https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview

The bill will allow the government to ensure that medical devices, such as pacemakers, breast implants and ultrasound imagers, continue to be subject to the highest …

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