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
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