In vitro penetration, distribution and absorption.

Classifications of substance-based medical devices

To comply with MDR and Rule 21

For devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, the EU Medical Device Regulation 2017/745 (MDR) specifies when absorption, distribution, metabolism and excretion (ADME) have to be demonstrated (MDR Annex I and II) and introduces how these devices should be classified (MDR Rule 21).

Specific expertise on medical device testing to assure the full management of each project

  • Collection and analysis of all relevant information

    As a first step, all the relevant information on the substances and devices will be gathered and evaluated.

  • Is additional testing necessary?

    If the existing data is sufficient, a toxicological risk assessment report will be delivered. Otherwise, a customized testing approach will be proposed to the client.

  • Robust and relevant testing approach

    In vitro penetration, distribution and absorption studies can be performed in compliance with GLP on human skin explants, 3D reconstructed human epidermis, full-thickness skin, 3D human epithelia (oral, gingival, vaginal, ocular, bladder, nasal, bronchial, colon-rectal and oesophageal mucosa) and intestinal models.

    The principles and quality requirements of OECD TG 428, the harmonized and scientifically valid standard method for in vitro absorption studies, are applied. The analytical method validation is performed.

  • Expert report

    Toxicological expertise associated with the in vitro penetration and absorption study will be provided. For the specific ingredient, toxicological risk assessment and safety margins calculation will be provided based on absorption and distribution experimental data.

Relevant standards:

  • 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
  • SCCS/1358/10 Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients

Robust and relevant testing approach

Protocols for penetration and absorption studies are established according to medical device type, formulation and intended use and performed:

  • To quantify selected ingredient’s penetration, absorption and local distribution
  • To support classification/re-classification of existing devices according to the MDR
  • To support the classification of new products that are applied to the skin, introduced via nasal, oral cavity or other body orifices, or with intended purpose in the stomach or lower gastrointestinal tract