Substance-based Medical Devices.
Qualify and classify your devices in compliance with the MDR
The EU Medical Device Regulation (MDR) 2017/745 introduces specific requirements for substance-based medical devices, which are composed of substances or combinations of substances intended for human use via ingestion, inhalation, or other routes.
A key change is the introduction of Rule 21 under Annex VIII, which applies a risk-based classification approach. Many devices that were previously classified as Class I under the former MDD are now being reclassified into higher-risk categories.
Proper qualification and classification are critical first steps towards achieving MDR compliance. Inaccurate classification or insufficient information can lead to costly delays in market entry. Key considerations include:
Mode of Action (MoA)
The qualification of a substance-based device depends on its Mode of Action (MoA). Manufacturers must provide clear evidence that the substance achieves its primary intended medical purpose through physical means rather than pharmacological, metabolic, or immunological action. This distinction is crucial for determining if the product qualifies as a medical device, directly influencing its classification.
Absorption, Distribution, Metabolism, and Excretion (ADME)
Manufacturers must also demonstrate the behavior of the device within the human body, focusing on Absorption, Distribution, Metabolism, and Excretion (ADME). Rule 21 of the MDR applies a risk-based classification approach that considers the device’s function and its interaction with the body, making the ADME data critical for accurate classification.
Toxicological Assessment of Materials and Substances
A comprehensive toxicological assessment of all materials and substances used in the device is required, as outlined in Section 10.4 of the MDR. Manufacturers must evaluate and provide a toxicological profile, ensuring that the materials used are safe and compliant with regulatory requirements.
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Services provided by SenzaGen Group companies VitroScreen and ToxHub. The VitroScreen in-vitro laboratory is ISO 9001 and ISO 13485 certified.
