EU Medical Devices Regulation (MDR 2017/745)

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 will change significantly.

Key changes

The aim of the new regulation is to ensure catching up fast evolving of science and technology in the field of medical devices. To do so, it introduces a number of key improvements, among them:

  • stricter 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.
  • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on UDI
  • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorization of multi-center 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.

MakroCare supports manufacturers in:

  • Gap analysis, advisory and planning Clinical Evaluation programs to meet MDR guidelines
  • Setting up Registries and PMCF programs
  • Advice and setup UDI program along with technology
  • Support PMS with formalizing plan for aggregate reports process creation to standardization of templates and required technology

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