2023 Medical Device Directive

provisions for certain medical devices and in vitro diagnostic …

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

Directive’s certificate or declaration of conformity, or in respect of a device intended to substitute that device under the MDR, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Annex …

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 …

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 Search for …

Medical Device Regulation Transition Extension Proposal

https://www.clinicalpathwaysresearch.com/blog/2023/1/17/medical-device-regulation-transition-extension-proposal

On January 6, 2023, the European Commission proposed an extension of the MDR transition period for ‘legacy devices’, medical devices that were already covered in …

Regulating medical devices in the UK - GOV.UK

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

The NIS 2 Directive establishes new cybersecurity requirements …

https://products.cooley.com/2023/01/03/the-nis-2-directive-establishes-new-cybersecurity-requirements-for-medical-device-manufacturers/

A recent legislative development concerning cybersecurity is relevant for the medical technology industry. This is the update to Directive (EU) 2022/2555 on the …

Department of Veterans Affairs VA Directive 6008 …

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1416&FType=2

January 06, 2023. 4 ACQUISITION AND MANAGEMENT OF VA INFORMATION TECHNOLOGY ASSETS 1. PURPOSE AND SCOPE: This directive establishes policy for …

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 …

New UK MHRA Medical Devices Regulations Published - NAMSA

https://namsa.com/uk-mhra-medical-device-regulations-published/

Transitional arrangements for UKCA marked devices before July 2023: This transitional arrangement for medical devices will allow, at a minimum, products to be …

2023 Medical Device Directive | Day of Difference

https://dayofdifference.org.au/0-9-medical/2023-medical-device-directive.html

An Introduction to the Medical Devices Directive provides a detailed introduction to the European medical device legislation. An Introduction to the Medical Devices Directive …