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Under the EU Medical Device Regulation (MDR), chemical characterisation helps manufacturers assess a device’s biological safety by identifying and evaluating chemicals that may be present or released. It is part of a risk-based evaluation—not a universal test recipe—and should reflect the final device, its manufacturing and sterilisation, and its intended exposure in clinical use.
Which regulations and guidance apply?
Regulation (EU) 2017/745 is the EU legal framework addressed here. European Commission Medical Device Coordination Group (MDCG) documents help explain how to apply the MDR, but they are not themselves legally binding. The Commission says this guidance represents a common understanding of applying the MDR and IVDR and is reviewed periodically. For legal obligations, consult the applicable MDR provisions; use guidance as an aid to interpretation. Commission guidance index
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Standards references also need edition and status checks. A Commission consolidated listing names EN ISO 10993-17 and EN ISO 10993-18, but the listing returned here does not establish the latest editions or their current harmonised status. Before relying on a conformity presumption or making an edition-specific claim, check the current EU harmonised standards publication and the applicable EN or national adoption. Commission consolidated standards listing
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What does chemical characterisation establish?
Chemical characterisation uses qualitative and quantitative methods to inform an understanding of a device’s material composition, purity, impurities and degradation products. Its results feed into biological evaluation and toxicological risk assessment; they do not, by themselves, establish that a device is biologically safe. The Commission’s MDCG 2020-5 guidance describes ISO 10993-1 as providing a risk-based approach to biological evaluation, and identifies these relevant standards:
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| Standard | Role described in Commission guidance |
|---|---|
| ISO 10993-18 | Chemical characterisation, including estimating the type and quantity of leachables from the final device and requirements for analytical-method quality. |
| ISO 10993-17 | Toxicological risk assessment of relevant constituents or leachables. |
| ISO 10993-13, 10993-14 and 10993-15 | Address degradation products from polymers, ceramics, and metals or alloys, respectively. |
These references identify parts of an evaluation, not a complete assessment for every device. Which materials, substances, methods and additional tests are relevant depends on the device and its use. MDCG 2020-5 guidance
What is the difference between extractables and leachables?
The terms describe chemicals obtained under different conditions. The distinction matters because a laboratory extraction result is not automatically a measure of what a patient will encounter during ordinary use.
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| Term | Meaning | How to interpret it |
|---|---|---|
| Extractables | Chemicals that can be extracted from a device under laboratory extraction conditions. | Can help characterise potential chemical constituents; the extraction conditions are not necessarily the same as clinical use. |
| Leachables | Chemicals released from a device under normal clinical-use conditions. | Relevant to evaluating substances that may be released during the device’s intended use. |
SCHEER’s 2024 guidance describes chemical characterisation as a way to inform the assessment of composition, purity, impurities and degradation products, and cites ISO 10993-18 as one method for evaluating chemical composition and leachables. Neither that reference nor the term “extractables” prescribes one extraction condition or analytical technique for every device. SCHEER 2024 guidance
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A defensible evaluation links the material and chemical findings to the device’s contact and exposure, then to a toxicological assessment and a device-specific biological-safety conclusion. In practice, the rationale should address the following sequence:
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- Define the device and its intended exposure. Establish which final-device materials and contact conditions are relevant, including the route, nature, degree, frequency and duration of contact.
- Characterise relevant chemicals. Use an approach justified for the device to identify and quantify relevant constituents, impurities, manufacturing or sterilisation residues, contaminants, leachables and degradation products as appropriate.
- Assess toxicological risk. Evaluate relevant chemical findings, including leachables, under ISO 10993-17 where applicable. The Commission’s biological-safety material describes material characterisation under ISO 10993-18 and toxicological assessment under ISO 10993-17 where relevant. Commission biological-safety document
- Document the biological-safety conclusion. Explain how the chemical evidence and risk assessment support the conclusion for this device and its intended use, and why any additional testing is or is not needed.
The sample selection, extraction conditions, analytical methods, acceptance criteria and need for further testing require a device-specific rationale. The cited sources do not establish a single best analytical technique for all devices.
Why should the evaluation use the final device?
The finished device—not merely its raw material—is the meaningful object of evaluation. Design, processing, manufacturing and sterilisation can change material properties or affect what is released. The use environment can also affect release. Potential leachables may include degradation products, material constituents, manufacturing or sterilisation residues, and contaminants. Similarity between raw materials alone therefore does not establish equivalent release characteristics. MDCG 2020-5 guidance
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What MDR provisions cover certain CMR and endocrine-disrupting substances?
SCHEER’s 2024 guidance summarises MDR Annex I, section 10.4.1: particular provisions apply when CMR category 1A or 1B substances, or specified endocrine-disrupting substances, are present above 0.1% weight by weight. These provisions include justification for the substance’s presence; chemical-characterisation information can contribute to compliance and benefit-risk assessment. This is not a blanket ban. Apply the exact legal text to the substance classification and device context, and check whether an applicable exception affects the case. SCHEER 2024 guidance
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