What are preclinical studies of medical devices?
Preclinical studies are a set of experimental activities conducted under laboratory conditions to confirm the biological safety, mechanical, chemical, and functional properties of a device before its use in humans. Unlike clinical studies, which involve patients, preclinical studies are conducted in vitro or in vivo (animal models) to generate data required under MDR (2017/745) and IVDR (2017/746).
Preclinical study results are a key element of the technical documentation and form the basis for risk assessment. They also support further clinical or performance evaluation. According to MDR/IVDR, all medical devices and IVDs must undergo preclinical testing, except for certain Class I devices without measuring functions or sterility requirements.
Scope of preclinical testing for medical devices
The scope of preclinical testing should be tailored to the specific characteristics of the device, its intended clinical use, and its risk class. Applicable standards and guidelines indicate the need to evaluate the biological, physical, and chemical aspects of the product.
- Biocompatibility assessment according to ISO 10993 series,
- Mechanical testing – strength, resistance to damage and fatigue,
- Chemical and toxicological testing – chemical composition, substance migration, processing residues,
- Functional testing – simulation of clinical use conditions,
- Sterilization process validation,
- Packaging system integrity assessment, especially for sterile products.
Biocompatibility of medical devices – ISO 10993
Biocompatibility studies form the basis for biological risk assessment. They are conducted in accordance with ISO 10993 standards, depending on the expected contact with the body, anatomical location, exposure time, and materials used.
- ISO 10993-5 – cytotoxicity,
- ISO 10993-10 – irritation and sensitization,
- ISO 10993-11 – local and systemic toxicity,
- ISO 10993-3 – mutagenicity and carcinogenicity.
The scope of testing must be justified based on risk analysis and, where possible, supported by literature data and material compliance information.
Mechanical and functional testing of devices
Mechanical tests verify the device’s resistance to forces that may occur during use. For implants, joint replacements, or surgical tools, testing may include fatigue strength, fracture resistance, stiffness, and deformation under force.
Functional testing involves simulating actual clinical conditions in the lab environment to assess whether the device performs its intended function. These tests may include flow, blockage, leakage, or compatibility with other systems and devices.
Validation of processes affecting device safety
Preclinical testing also includes validation of manufacturing processes that impact device safety, particularly:
- Sterilization validation – in accordance with ISO 11135 (ETO), ISO 17665 (steam), or ISO 11137 (radiation),
- Packaging integrity validation – according to ISO 11607,
- Analysis of chemical residues, endotoxins, and processing agents.
The effectiveness of these processes must be documented in the technical file, and their repeatability confirmed according to quality assurance principles.
MDR and IVDR requirements for preclinical data
The MDR and IVDR regulations clearly require the submission of preclinical data as part of evidence of compliance with essential requirements. These data must be thoroughly documented and linked to the clinical or performance evaluation and risk assessment.
- Description of the testing methodology and results,
- Reference to applicable standards and justification for their use,
- Connection of the results to essential requirements and safety/performance evaluation.
Differences between preclinical and clinical studies
Preclinical studies are conducted before the first human use of the device and aim to ensure safe application based on laboratory data. They include both biological and physico-chemical tests. Clinical studies, on the other hand, are carried out with patient involvement and assess the device’s performance in a real medical setting.
According to the MDR, preclinical study results may justify exemption from clinical investigations if the device is well-characterized, based on known materials, and does not pose new risks.
The role of preclinical studies in technical documentation
Data from preclinical studies are a critical part of the device’s technical documentation and are required under Annex II of MDR/IVDR. They must be clearly linked with other components of the documentation — including risk assessment, clinical evaluation, and application of harmonized standards.
- Description of device design and intended use,
- Assessment of compliance with essential requirements,
- Basis for defining PMS and PMCF/PMPF parameters,
- Supporting evidence for notified body review in the certification process.
Pure Clinical’s role in preclinical studies
Pure Clinical supports medical device and IVD manufacturers in designing, coordinating, and documenting preclinical studies in accordance with MDR and IVDR requirements. Our services include:
- risk analysis and selection of appropriate preclinical studies,
- development of testing plans in line with applicable standards,
- collaboration with accredited laboratories and oversight of study execution,
- preparation of test reports for inclusion in the technical documentation.
We support manufacturers of both Class I and advanced Class III devices, implants, sterile systems, and IVDs. Our goal is to help you navigate the certification process efficiently and avoid errors or delays in regulatory compliance.
FAQ
Are all preclinical tests required to be conducted physically, or can literature data be used?
Does a material change in the device require repeating preclinical studies?
How should the omission of a preclinical test be documented?
Can a manufacturer outsource preclinical testing to a non-EU laboratory?
Yes, but the lab must be accredited (e.g., ISO/IEC 17025) and follow methodologies aligned with EU regulatory requirements. Notified Bodies will expect access to raw data, detailed protocols, and proof of procedural equivalence to EU standards.