• Medical device testing is one of the more complex services offered in the life sciences sector, both for the diversity of the products tested and for the different levels of safety or biocompatibility required prior to approval for use in patients.
• There is a high demand for reliable testing services for medical devices as it is one of the fastest growing industries in healthcare. The European medical device industry, constituting 1/3rd of the global market, is thought to be worth approximately 100 billion euros.
• Within the U.S., the Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of medical devices. The U.S. FDA were given authority to begin regulating all medical devices in 1976, when the president signed the Medical Devices Amendments Act.
• The European Union’s (EU) rules relating to performance and safety of medical devices were harmonised during the 1990s and recently updated in 2017 with two applicable regulations: the medical device regulations (MDR) and the in vitro diagnostic regulations (IVDR).
Medical Device Testing Overview:
• The classification of a medical device covers a wide range of device types, each requiring various levels of safety or biocompatibility testing before market release.
• All biocompatibility testing carried out should adopt a tiered approach to minimize the amount of in vivo testing required. This means that before any testing takes place, it is essential to have both the device and the materials used for manufacturing assessed to ensure the correct route of testing or evaluation is taken.
• ISO 14971: Application of risk management to medical devices is a standard that specifies a process for the manufacturer to identify any hazards associated with the device. These specifications should always be adhered to and the standard is applicable to all stages of the medical device life-cycle.
• In addition, pharmaceutical and medical device manufacturers should always consider environmental monitoring before manufacturing as this can lower the risk of contamination and help them to understand the levels of microorganisms within their environments.
In the Lab / at Wickham Micro Ltd
• Before considering testing, we work with our clients to determine the appropriate regulatory pathway for their situation, keeping our ethical obligations at the forefront. We may recommend a Biological Evaluation Report instead of a full suite of testing, which could save the client money and reduce unnecessary testing.
– 10993-3: Genotoxicity
– 10993-4: Haemocompatibility
– 10993-5/USP 87: Cytotoxicity
– 10993-6/USP 88: Implantation
-10993-10/USP 88: Sensitisation, Skin
– 10993-11/USP 88: Acute, Sub-acute, Chronic Systemic Toxicity and Pyrogenicity
– 10993-13: Identification and Quantification of Degradation Products from Polymers
– 10993-14: Identification and Quantification of Degradation Products from Ceramics
– 10993-15: Identification and Quantification of Degradation Products from Coated and
Uncoated Metals and Alloys
– 10993-18: Chemical Characterisation of Materials
• There are a variety of other tests which may be required including:
– 11135-1 and 11737-2: Sterility Testing
– 11737-1: Bioburden Determination