Mechanism of action on 3D reconstructed human tissues.

Demonstrate the mechanism of action of medical devices

To comply with MDR

According to the EU Medical Device Regulation 2017/745 (MDR), the manufacturers of medical devices should demonstrate with scientific evidence, when necessary, that the principal mechanism of action of the medical devices is not pharmacological, immunological, or metabolic (Ph.I.M).

Standard and customized protocols on 3D reconstructed human tissue models allow us to provide experimental evidence that a medical device acts at the superficial level and that its principal mechanism of action is physical, mechanical, or chemical and not Ph.I.M.

Experimental evidence addresses specific therapeutic areas, including dermatology, gastroenterology, gynaecology, ophthalmology, oral care, urology and respiratory tract and pharmacological expert reports contribute to solving issues related to Ph.I.M effects.

The customized protocols are ranked in 4 levels according to the complexity of the mechanisms to be demonstrated and/or excluded.

  • Level 1

    Physical, mechanical, chemical means

  • Level 2

    Superficial action not interfering with homeostasis

  • Level 3

    To exclude pharmacological, metabolic, immunological mechanisms

  • Level 4

    Customized projects for invasive devices acting at the target organ level

Relevant standards:

  • Regulation (EU) 2017/745 of the European Parliament and the Council of 05 April 2017 on medical devices (MDR)
  • MDCG 2021-24 Guidance on classification of medical devices

Get expert advice

In vitro testing protocols on 3D reconstructed human tissues and pharmacological expert reports are provided to confirm that the medical device acts at the superficial level and the principal mechanism of action is physical, mechanical, or chemical and not linked to pharmacological, immunological or metabolic effects.