Medical Device Classification.
Need to classify or re-classify your substance-based devices?
The EU Medical Device Regulation (MDR) imposes stricter classification requirements for substance-based medical devices, particularly those absorbed by the body. While demonstrating Absorption, Distribution, Metabolism, and Excretion (ADME) profiles is not entirely new, the MDR places greater emphasis on ADME data for classification (MDR Annex I and II).
Rule 21 (MDR Annex VIII) introduces a more detailed, risk-based classification approach for substance-based Medical Devices. This rule requires manufacturers to demonstrate how the substances behave within the body and evaluate the risk to users, based on the ADME profile. Devices that were previously classified as Class I (low-risk) under the Medical Device Directive (MDD) are now being reclassified into higher-risk categories (Class IIa, IIb, or III).
Accurate classification based on the ADME profile is critical for MDR compliance.
Establishing ADME profile for MDR compliance
We follow a systematic, stepwise approach to help you establish the ADME profile and meet MDR classification requirements:
1. Collection and analysis of all relevant information
The first step involves gathering and evaluating all available data on the substances and the device. This includes any existing ADME data to ensure a complete understanding of how the device interacts with the human body.
2. Determining the need for additional testing
If existing data is sufficient, a toxicological risk assessment report is prepared. If further data is required, we propose a tailored testing approach to meet MDR compliance for your device classification.
3. In vitro testing to demonstrate ADME profile
We conduct in vitro penetration and absorption studies using validated protocols, designed to meet the specific needs of each medical device. Testing is performed on a variety of tissue models, including:
- Human skin explants
- 3D reconstructed human epidermis
- Full-thickness skin
- 3D human epithelial models (oral, gingival, vaginal, ocular, bladder, nasal, bronchial, colon-rectal, and oesophageal mucosa)
- Intestinal models
These studies follow the principles of OECD TG 428, the internationally recognized standard method for in vitro absorption studies, using fully validated analytical methods.
4. Expert report
Our toxicological experts provide a detailed report based on the in vitro penetration and absorption study, including a toxicological risk assessment for specific ingredients. Safety margins are calculated based on the experimental ADME data, helping to ensure accurate classification in line with MDR requirements.
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
- OECD TG 428 Skin absorption: in vitro method
- SCCS/1358/10 Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients
Get expert support for your testing and regulatory needs
We help you navigate the regulatory landscape with comprehensive testing services and expert guidance.
From planning and documentation to interpreting test results, reporting, and communicating with Notified Bodies, we’ve got you covered.
- Support the classification or reclassification of both new and existing devices under the MDR.
- Expert advisory services to help interpret study results, ensuring informed decisions regarding regulatory compliance and product development.
Services provided by SenzaGen Group companies VitroScreen and ToxHub. The VitroScreen in-vitro laboratory is ISO 9001 and ISO 13485 certified.
