The EU Medical Devices Regulation (MDR 2017/745)

On April 5, 2017 the EU adopted the new Medical Devices Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation will enter into force after a three-year transition period ending in spring 2020. This means that the market access framework for all member countries of the European single market (28 EU member states including the UK, the members of the EEA – Iceland, Lichtenstein and Norway, and through bilateral treaties Switzerland) will change significantly.


Key changes

The aim of the new regulation is to address some inherent weaknesses in the old directives as well as the swift evolution of science and technology in the field of medical devices. To do so, it introduces a number of key improvements, among them:

  • 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.
  • 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.                                                 

Source: ec.europa.eu


Time line

  • April 5, 2017: The EU Medical Device Regulation was adopted.
  • May 5, 2017: The Regulation was published in the Official Journal of the European Union.
  • May 26, 2017: The Regulation entered into force and will apply in parallel with the current medical devices directive MDD 93/42/EEC for a transition period of three years.
  • December, 2017: The process of re-designating Europe’s Notified Bodies under the new regulation begins. The first designations are expected to be finalized some 12 to 18 months from the date of publication of the legislation.
  • May 25, 2020: The transition period ends and the Medical Devices Regulation becomes mandatory.

 

How can manufacturers prepare for the transition?

Considering the amount of work that needs to be done, the three-year transition period is short. Manufacturers need to start preparing now to make sure their products are compliant by May 25, 2020. Here’s how to get started:

  1. Make sure your company has a thorough understanding of the new legislation and the changes from the current Medical Devices Directive.
  2. Conduct thorough gap assessments to review your current products against the new legislation. The gap assessments should also take into account the reclassification of certain product groups as well as MDR’s wider definition of a medical device.
  3. Bear in mind that the management system standard for medical device manufacturers – ISO 13485 – has also been updated. The final date for transitioning to the new edition (ISO 13485:2016) is February 28, 2019.
  4. Keep in touch with us to discuss the time line for your transition. Intertek intends to be designated under the new regulation.


Resources:

More information on the Medical Devices Regulation can be found on the European Union’s website: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision

 
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