Belső piac, ipar-, vállalkozás- és kkv-politika

New regulations

New regulations

From contact lenses and sticking plasters to pacemakers and X-ray scanners, medical devices and in vitro diagnostic medical devices are essential to our health and quality of life as well as to the European economy.

We all expect medical devices to be safe and to incorporate the latest progress in science and manufacturing technology. Since the EU’s rules on the safety and performance of medical devices were laid down in the late 1990s, however, there have been discrepancies in their interpretation across Europe. Issues have also arisen in some categories of medical devices, for instance breast implants and metal-on-metal hip implants.

To reflect progress over the last 20 years, the EU has therefore revised the legal framework. 2 new regulations – one on medical devices and the other on in vitro diagnostic medical devices – were adopted by the Council and the Parliament, and entered into force in May 2017.

The new rules will only fully apply after a transitional period. That period lasts for 3 years after the entry into force of the regulation on medical devices (i.e. until May 2020), and 5 years after the entry into force of the regulation on in vitro diagnostic medical devices (i.e. until May 2022).

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

Read the press release from the European Commission

The new regulations in a nutshell

The new regulations contain a series of extremely important improvements to modernise the current system. Among them are

  • stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
  • reinforcement of the criteria for designation and processes for oversight of notified bodies
  • inclusion of certain aesthetic devices that present the same characteristics and risk profile as analogous medical devices under the scope of the regulations
  • a new risk classification system for in vitro diagnostic medical devices in line with international guidance
  • improved transparency through a comprehensive EU database on medical devices and a device traceability system based on unique device identification
  • introduction of an ‘implant card’ for patients containing information about implanted medical devices
  • reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorising multi-centre clinical investigations
  • strengthening of post-market surveillance requirements for manufacturers
  • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

More information is available in this presentation that contains general information on key changes contained in the regulations and transitional periods.

See the new rules to ensure safety of medical devices.

All actors involved with medical devices, from their manufacture to their use, will have to comply with the new Regulations by May 2020 (May 2022 for in vitro diagnostic medical devices). It is important that all actors are fully aware of the changes and start preparing for the implementation of the new Regulations as soon as possible.

On these web pages you will find information targeted at the various actors in the section getting ready for the new regulations and on several horizontal topics in the section topics of interest.

Be aware that the European Commission is not responsible for content provided by non-Commission websites.

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The main reasons behind this change

Problems with diverging interpretation of the current Directives as well as the incident concerning fraudulent production of the PIP silicone breast implants highlighted weaknesses in the legal system in place at the time and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the 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 medical devices regulations

Implementing measures for Regulations

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.

As of 26 November 2017, conformity assessment bodies may apply for designation as notified bodies under Regulations (EU) 2017/745 and 2017/746. Guidance documents and forms are available in MDCG documentsThis explanatory note provides answers to the most frequent questions asked about the designation process, and in particular the scheduling of joint assessments.

Information on the applications for designation as a notified body: Short overview of the state-of-play of joint assessments of Notified Bodies in the medical device sector at the date of 9 April 2019.

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. 

Use this document together with the 'MDR/IVDR roadmap', produced by the competent authorities for medical devices project (CAMD) and the Commission. The roadmap is more comprehensive. It gives an overview of all the Commission's and national competent authorities' expected initiatives (including guidance) during the transitional period.