Overview

Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…

Directives

The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...

New Regulations

The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The…

Latest updates

News announcement
13 July 2022

MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)

News announcement
5 July 2022

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746

News announcement
13 June 2022

MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements

News announcement
25 May 2022

MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

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Highlights

Benchmarks for high-risk diagnostics

News announcement
21 June 2022

Setting the scene for EU reference labs for high-risk diagnostics

26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU

News announcement
24 May 2022

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

News announcement
26 May 2021

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices

The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities

Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices

Events

07May2021

Partner meetings

Webinar for Patients – Safe and performant Medical Devices for all

Medical Devices - Sector

Overview

Directives

New Regulations

Latest updates

MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746

MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements

MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

Highlights

Benchmarks for high-risk diagnostics

Setting the scene for EU reference labs for high-risk diagnostics

26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices

The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities

Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices

Events

Documents

Events

Publications