2023 Medical Devices Directive

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provisions for certain medical devices and in vitro diagnostic …

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

90/385/EEC on active implantable medical devices (AIMDD)8 and Council Directive 93/42/EEC on medical devices (MDD)9 that will expire between January 2023 and 26 May 2024. Of those 21,376 certificates, 4,311 certificates will expire in 2023 and 17,095 …

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 …

January 2023 Medical Device and IVD News Update | NSF

https://www.nsf.org/news/jan-2023-medical-device-ivd-update

These challenges are hurting the most important stakeholders; the patients and users of these medical devices. The European Commission published its proposal …

Devices Approved in 2023 | FDA

https://www.fda.gov/medical-devices/pma-approvals/devices-approved-2023

This page lists all medical devices approved through the CDRH Premarket Approval process (PMA) in 2023. For access to the approval packages for PMA originals …

Medical Device Regulation Transition Extension Proposal

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

01/17/2023. The European Union, excluding the United Kingdom, regulates medical devices under the Medical Device Regulation (MDR) (Regulation EU …

Harmonised standards - Public Health

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

Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the …

Medical Devices Directive - Hazardous Substances

https://echa.europa.eu/eu-medical_devices-anx_i_7_8

Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007 This list contains …

UKCA Compliance for Medical Devices: What You Need …

https://www.mddionline.com/regulations/ukca-compliance-what-you-need-know-and-implement-june-2023

In addition, given the fact that the UK MDR is based on previous European Medical Device Directives, manufacturers may find they have already or nearly met all …

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 Entities …

Sustainability Drives the Medical Device Packaging …

https://www.mddionline.com/packaging/sustainability-drives-medical-device-packaging-industry-2023

1 day ago · The medical device packaging industry is coming out of the pandemic’s supply and demand rollercoaster and entering 2023 forecasted for strong, stable growth. The …

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