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Public Health

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 priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. Two new regulations on medical devices and in vitro diagnostic medical devices entered into force in May 2017. With effect from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.

With effect from 26 May 2022, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices replaces Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices after a transition period. Read the press release from the European Commission.

In order to get ready for the new regulations, the Commission prepared detailed information for all actors involved.

Dedicated factsheets provide a summarised view of the main areas of activities in the medical devices sector.

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
  • Regulation 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions
  • Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

Corrigenda to the regulations

Implementing measures for regulations

  • Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council
  • Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices
  • Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)
  • Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices
  • Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746
  • Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices
  • Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices

Delegated acts adopted under the regulations

  • Report from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, COM(2022)182 final of 26 April 2022

Rolling plan

This rolling plan contains the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play.

Its 2 main sections are implementing acts and other actions/initiatives. The rolling plan will be reviewed quarterly to provide operators with the latest information.

The rolling plan can be used together with the 'MDR/IVDR roadmap', jointly produced by the competent authorities for medical devices project (CAMD) and the European Commission.

The roadmap is more comprehensive. It gives an overview of all the expected initiatives (including guidance) during the transitional period.

For Regulation (EU) 2017/746 on in vitro diagnostic medical devices, a joint implementation plan was endorsed in principle by the Medical Device Coordination Group (MDCG). Input from stakeholders was taken into account. The plan outlines the essential and high-priority actions that are to be completed before the date of application of IVDR, across relevant MDCG sub-groups. The actions include the most crucial of those listed in the rolling plan and in the document on ongoing guidance development, as well as other actions specifically related to contingency planning and monitoring of the transition to Regulation (EU) 2017/746.

In addition to setting priorities, the joint implementation plan serves to monitor progress. The status and timelines of each action are regularly reviewed in MDCG meetings and updated to reflect the progress with each work item.