Medical Devices - Sector

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 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. They will progressively replace the existing directives after a transition period.

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

Read the press release from the European Commission

On 14 October 2021, the Commission made a proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices (COM(2021)627 final). The aim of the proposed Regulation, which needs to be adopted by the European Parliament and the Council, is to smooth the transition from the current Directive 98/79/EC to the new Regulation (EU) 2017/746 in order to prevent disruption in the supply of essential in vitro diagnostic medical devices. See also press release, Q&A and informative slides on the proposal.

The main reasons behind this change

Problems with divergent interpretations of the current Directives, as well as incidents concerning product performance, highlighted certain weaknesses in the legal system. Revision of the legislation was necessary to reinforce high standards of product quality and safety and consolidate the role of the EU as a global leader in the medical devices sector.

The new regulations will ensure

  • a consistently high level of health and safety protection for EU citizens using these products
  • the free and fair trade of the products throughout the EU
  • that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years

Corrigenda to the regulations

Implementing measures for regulations

  • 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

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.