Medical Devices - Sector

New Regulations

  1. Italiano
  2. English

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.

On 23 April 2020 the Council and the Parliament adopted Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of its provisions. This Regulation postpones the date of application for most Medical Devices Regulation provisions by one year – until 26 May 2021 and enters into force on the day of its publication in the Official Journal of the European Union.

  • 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

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) 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.