Overview.

Joint expertise on medical devices

SenzaGen and VitroScreen guide you through the comprehensive process of biological evaluation of medical devices:

  • Product identification

    In vitro approaches to demonstrate the mechanism of action by using 3D reconstructed human tissues.

  • Substance-based medical devices classification

    In vitro penetration, distribution and absorption studies to comply with MDR and Rule 21.

  • Risk identification

    GAP analysis and Biological Evaluation Plan (BEP).

  • Risk mitigation

    In vitro biocompatibility testing according to ISO 10993-1 and permeation, distribution and absorption studies according to OECD TG 428.

  • Evaluation of results

    Biological Evaluation Report (BER), including toxicological risk assessment, safety margins calculation and biological testing interpretation.

Relevant standards:

ISO 10993 standard series; Biological evaluation of medical devices

US FDA guidance document on ISO 10993-1 (2020)

ISO 14971:2019 Medical devices – Application of risk management to medical devices

Regulation (EU) 2017/745 of the European Parliament and the Council of 05 April 2017 on medical devices (MDR)

OECD TG 428 skin absorption: in vitro method

Services summary
 

In vitro biocompatibility testing

Our GLP-certified laboratories provide in vitro biocompatibility testing addressing the three endpoints that all medical devices are subjected to assess: cytotoxicity ISO 10993-5, irritation on skin and other epithelia according to ISO 10993-23, and skin sensitization according to ISO 10993-10 with GARD®.

Mechanism of action on 3D reconstructed human tissues

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.

In vitro penetration, distribution and absorption

Protocols for penetration and absorption studies are established according to medical device class and type, formulation and intended use, and performed to quantify selected ingredients’ penetration, absorption and local distribution. This data is used to support the classification/re-classification of existing devices according to the MDR and the classification of new products that are applied to the skin, introduced into the body via body orifices, or with intended purpose in the stomach or lower gastrointestinal tract.

Tailored consultancy services

The in vitro testing and pharmaco-toxicological consultancy services provide expert advice during product development and/or to respond to regulatory requirements: for product identification as medical devices and medical device classification, risk identification, risk mitigation by in vitro testing and evaluation of results in the Biological Evaluation Report (BER).