The EU Medical Devices Regulation (MDR 2017/745)

On April 5, 2017, the EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive.

The new Medical Device Regulation will enter into force after a three-year transition period ending on May 25, 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 Medical Device 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 several 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

    How can manufacturers prepare for the transition to MDR?

    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. Keep in touch with us to discuss the timeline for your transition. Intertek intends to be designated under the new regulation.

    Intertek Medical Notified Body (IMNB)

    Medical Device certification under the new Medical Device Regulation, MDR (2017/745) will be offered through our new legal entity Intertek Medical Notified Body AB (IMNB AB) following our designation in 2019. The headquarters for this Notified Body will remain in Stockholm, Sweden. We will continue to have our teams based around the globe, including but not limited to North America, China, United Kingdom, Poland, Israel, and Sweden. If you are a client and have a current MDD certificate(s) with us, these will remain under SEMKO AB NB 0413 until that certificate expires, unless you are specifically notified otherwise. Please note that new agreements need to be set up to maintain validity of MDD certificates after 25 of May 2020.

    Basic steps of the new MDR application process

    MDR designation status

    IMNB is in progress to achieve the MDR Designation.

    Contact for IMNBmedtechsweden@intertek.com

    Resources

    More information on the Medical Devices Regulation can be found on the European Union’s website:ec.europa.eu

     
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