Medical device testing is a key part of the process of ensuring the safety, efficacy and compliance of products with European Union requirements. The MDR 2017/745 and IVDR 2017/746 regulations require manufacturers and other players in the medical device market to conduct a wide range of tests and evaluations to ensure that products meet the highest quality standards.
Pre-clinical studies of medical devices
What are pre-clinical studies?
Preclinical studies are laboratory tests that are carried out before the start of clinical trials. They include biocompatibility tests, mechanical strength tests, microbiological tests, physical tests, chemical tests, among others.
Examples of pre-clinical studies
- Cytotoxicity tests of new materials in orthopaedic implants: Assessment of whether materials used in implants cause toxic cellular reactions.
- Mechanical strength tests of joint prostheses: Verifying that knee and hip prostheses can withstand the stresses of daily use.
- Toxicity testing of catheter materials: Analysis of whether catheter materials are safe and do not cause allergic reactions in patients.
Clinical studies of medical devices
What are clinical trials of medical devices?
Clinical trials of medical devices are studies conducted with human subjects to assess the safety and efficacy of a medical device. MDR 2017/745 requires every device to undergo appropriate clinical trials before being placed on the EU market.
MDR requirements for clinical trials
According to the MDR, clinical trials must be conducted in accordance with international standards, such as ISO 14155, and must include, among others:
- A clinical trial plan,
- Consent of the bioethics committee,
- Patient recruitment,
- Data monitoring and analysis,
- Final report of the clinical trial.
Examples of clinical trials
- Trial of anew type of vascular stent: Study to evaluate the effectiveness of a stent in preventing restenosis in patients with coronary artery disease.
- Test of anew glucose monitoring device: Evaluation of the accuracy of blood glucose measurements in patients with type 1 and type 2 diabetes.
- Evaluation of a new knee endoprosthesis: A study comparing the functional outcomes and comfort of patients using the new endoprosthesis compared to traditional models.
Electromagnetic compatibility (EMC) studies
What are EMC tests?
Electromagnetic compatibility (EMC) testing assesses whether a medical device functions correctly in an environment with various sources of electromagnetic interference. This is particularly important for electronic devices such as patient monitors or defibrillators.
Examples of EMC testing
- Testing a defibrillator in a hospital setting: Checking that the device works properly in the presence of other devices emitting electromagnetic signals.
- EMCassessment of a heart monitor: Testing whether the monitor works correctly in an environment with strong electromagnetic fields, such as near an MRI.
- EMC tests for mobile X-ray machines: Checking that mobile X-ray machines do not interfere with other medical devices.
Electrical safety testing of medical devices in accordance with IEC 60601
What are electrical safety tests?
Electrical safety testing of medical devices aims to ensure that electrical equipment used in healthcare is safe for patients and medical staff. IEC 60601 specifies the safety and performance requirements for electrical medical devices.
Importance of IEC 60601
IEC 60601 is an international standard that regulates the electrical safety and basic performance of electrical medical devices. Adherence to this standard is necessary for medical devices to be placed on the EU market and obtain certification in accordance with MDR 2017/745.
Key requirements of IEC 60601
IEC 60601 covers a wide range of electrical safety requirements, including:
- Protection against electric shock: Equipment must be designed to minimise the risk of electrical shock to patients and operators.
- Resistance to surges and interference: Equipment must be able to withstand surges and electromagnetic interference that may occur in the hospital environment.
- Mechanical safety: This includes design aspects such as the strength of the housing and mechanical protection to prevent access to live parts.
- Environmental testing: Devices must function properly under a variety of environmental conditions, such as humidity, temperature and pressure.
Usability tests for medical devices
What are usability tests for medical devices?
Medical device usability studies are studies to assess how end-users (e.g. doctors, nurses) use a device in real working conditions. These studies help to identify potential problems related to the use of the device.
Importance of usability studies
Usability studies are important because they allow early detection and resolution of problems that may affect patient safety or treatment effectiveness.
Examples of usability studies
- Evaluation of a self-filling syringe: Usability testing under field conditions to see if the syringe is easy for medical staff to use in emergency situations.
- Infusion pump user interface testing: Testing to assess whether the interface is intuitive and whether medical staff can easily programme drug doses.
- Usability analysis of a new type of non-contact thermometer: Testing whether medical staff and patients can use the thermometer correctly under different lighting and ambient conditions.
Post-market Clinical Follow-up (PMCF) studies
What are PMCF studies?
Post-market Clinical Follow-up (PMCF) is the continued monitoring of a medical device after its launch. The purpose of PMCF is to collect data on the long-term safety and efficacy of the device.
Importance of PMCF studies
PMCF testing is a key element of a risk management strategy and helps manufacturers detect potential problems that may arise after a device has entered daily use.
Examples of PMCF studies
- Monitoring patients with implanted vascular stents: Long-term study to detect potential stent durability problems.
- Tracking the use of a new pacemaker model: Collecting data on the efficacy and safety of the pacemaker in different patient populations.
- Assessing the long-term effectiveness of hearing prostheses: Investigating how new hearing prostheses affect patients’ quality of life over several years of use.
IVD device analytical studies
What is analytical testing of IVD devices?
Analytical testing of in vitro diagnostic (IVD) devices is research to assess the performance, precision, specificity and sensitivity of diagnostic devices used to test biological samples. They are key to ensuring that diagnostic results are reliable and accurate.
IVDR requirements for analytical testing
IVDR 2017/746 requires analytical testing to include:
- Assessment of analytical accuracy.
- Evaluation of repeatability and reproducibility.
- Stability tests.
- Interference and specificity analysis.
Examples of analytical tests
- Assessingthe accuracy of an HPV test: Testing whether the test can detect all known HPV types with high precision.
- Performance testing of a new glucose test:Testing whether the test gives accurate results at different blood glucose concentrations and under different environmental conditions.
- Assessing the specificity of the SARS-CoV-2 antibody test: Testing that the test does not show false positives in the presence of other coronaviruses.
Testing of medical devices in accordance with the requirements of MDR 2017/745 and IVDR 2017/746 is a key element in ensuring the safety and efficacy of these products. They range from clinical, usability and preclinical testing to post-market monitoring. Meeting these requirements is not only necessary to achieve certification, but also to ensure that medical devices are safe for patients and effective in clinical practice. Conducting comprehensive studies and meticulously documenting the results are the cornerstones of success in the medical device industry.
We work with partners and centres that conduct pre-clinical and clinical studies.