Substance-based Medical Devices.

Compliance with MDR

The new EU Medical Device Regulation 2017/745 (MDR) has defined more strict criteria for the quality and safety requirements of Medical Devices.

The following areas have been recognized and are specifically addressed as the key fundamentals within the pre-clinical evaluation of medical devices:

  • Material and substances

    The choice of materials and substances used, particularly their toxicological profile.

  • Biocompatibility

    The biocompatibility between the materials/substances used in the medical device and human tissues, cells, and body fluids taking into account the intended purpose of the device.

  • Product identification as medical device

    The need to demonstrate with sound experimental data the principal mechanism of action of the device which cannot be pharmacological, immunological, or metabolic.

  • Medical device classification

    The need to assess absorption, distribution, metabolism and excretion (ADME) in order to address safety concerns (MDR, Annex I and II) and classification issues for substance-based medical devices (MDR, Rule 21).

Get expert advice from our Group company VitroScreen

Standard and customized in vitro experimental protocols for: