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Regulatory framework

Regulatory framework

The new Regulations on medical devices

On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives.

  • 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

The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.

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
  • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies
  • the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
  • the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance
  • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
  • the introduction of an “implant card” containing information about implanted medical devices for a patient
  • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
  • the 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.

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

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. This explanatory note provides answers to the most frequent questions asked about the designation process, and in particular the scheduling of joint assessments.


Current medical devices Directives

Ranging from simple sticking plasters and contact lenses to sophisticated pacemakers and hip replacements, medical devices and in vitro diagnostic medical devices are important to our health and quality of life. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation.

Medical devices within the EU are currently regulated by the following 3 directives:

Implementing measures for Directives

The Commission has adopted several implementing measures based on the Medical Devices Directives. These measures concern, among others, medical devices manufactured using tissues of animal origin, the classification of certain medical devices and Common Technical Specifications for In vitro diagnostics (IVDs)s, listed in Annex Ⅱof the IVD Directive.

See key documents on recommendations, classification and other amending and implementing legislation below:

Recommendations

Classification

Other amending and implementing legislation

Guidance

In addition, legally non-binding guidance documents, MEDDEVs, consensus statements and informative documents pursue the objective of ensuring uniform application of the relevant provisions of the directives within the EU.

Please note that all guidance and implementing measures under the current Directives will be reviewed over the next few years in the light of the texts of the 2 new Regulations. See 'new Regulations' above for more information.

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