The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (or the MDR) replaces the Medical Device Directive 93/42/EEC.

In general, new regulations set forth additional requirements applicable to medical devices. Since the Regulation aims to increase safety and protect public health, it introduces several important changes including the following:

  • Increasing role of Notified Bodies – special entities designated by national regulating authorities to review market applications, conformity assessments, and examine medical products. Notified Bodies are also responsible for post-market surveillance.
  • Additional rules of risk-based classification for several types of medical devices.
  • Additional requirements on pre-market trials and examination to ensure the safety of the products.

The Medical Device Regulation also implemented two entirely new elements:

  • Unique Device Identification (UDI). Each medical device distributed within the EU market would have a special number allowing for individuals to find more details about the device such as its purpose, associated risk, the device manufacturer and its authorized representative. All information would be stored in a special database which would simplify access.
  • Person responsible for compliance. Medical device manufacturers shall designate one particular specialist as the person responsible for regulatory compliance. This person would maintain communications with regulating authorities. To be able to carry on such functions, designated person should have proper qualifications and professional experience.

These new regulations expanded the scope of applications substantially – now it include devices that are not intended for medical purposes, along with different prognosis devices.

The MDR became effective on May 25, 2017. There is a special transitional period that will last for three years until May 26, 2020, that provides medical device manufacturers with enough time to comply with new regulations.

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