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Public Health

New Regulations

About the revision

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

Extension of the transition periods provided for in the regulations

  • Regulation (EU) 2022/112 of the European Parliament and the Council of 25 January 2022 introduced a staggered extension of the transition periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and deferred the application of conditions for in-house devices. While the IVDR has been applicable since 26 May 2022, the amendment allows for its progressive rollout regarding in vitro diagnostics covered by a certificate or a declaration of conformity issued in accordance with the previous IVD Directive 98/79/EC.

  • New Commission proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The proposed Regulation, that needs to be adopted by the European Parliament and the Council, aims at introducing a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions. It also aims at deleting in both MDR and IVDR the 'sell-off' deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have to be withdrawn.

Corrigenda to the regulations

Implementing measures for regulations

  • Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose
  • Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
  • 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.

Guidance

Guidance documents aiming at an effective and harmonised implementation of the legislation are available. They present a common understanding of how the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices should be applied in practice.

The majority of these documents are drafted in collaboration with interested parties represented in the various concerned working groups and are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR.