The New Medical Device Regulation - an improved system

The New Regulations on Medical Devices as published May 5th, 2017 - The New Regulations in a Nutshell.

[Find the document referred to here, under the MCC page on the SACRA website under Resources]

On 5 April, 2 new Regulations on medical devices were adopted by the EU namely EU2017/745 and 2017/746. These replace the existing Directives for medical devices and in vitro medical devices respectively i.e. 90/385/EEC and 93/42/EEC, 98/79/EC 2010/227/EU .

These regulations were published May 5, 2017 in the Official Journal of the European Union (OJEU) and entered into force occurred on May 26, 2017.

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 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 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.

Find the highlighted MDR document on the SACRA website.

Clinical investigations is specifically mentioned in Article 62 starting on page 59 to page 73.

Please feel free to circulate this document to interested parties.