Medical Devices, according to the WHO, are defined as instruments, apparatus, implements, machines, appliance, implants, reagents for in vitro use, materials or other similar or related articles intended by the manufacturer to be used, alone or in combination, for human beings, for specific medical purposes. They are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. They do not exert a direct pharmacological, immunological, or metabolic effect but primarily act by physical means. They must be safe and reliable not only according to their defined usage but also with regard to potential adverse effects upon getting in contact with the patient. In this context toxic effects in general, irritating properties to the skin and the eye, allergenic potential as well as genotoxic effects and the influence on the germ line have to be strictly excluded.
The extensive demands on risk assessment incorporated in the new Medical Device Regulation (EU) 2017/745 require a tremendously high analytical investment. Being aware that the demands of the MDR amendments might overtax the testing slots of routine laboratories, MicroMol has extended its Biocompatibility & Safety Testing Services.
„According to the MDR amendment a single test strategy within the medical devices’ development phase is no longer sufficient!“, explains Wolfgang Rudy, Chief Scientific Officer of the MicroMol Laboratories. „The producer and the processor must proof that neither toxic, nor irritating and sensitizing effects will be induced during or because of repeated cleaning and / or sterilization cycles of a reusable device. As a result of the fact that the MDR demands a risk assessment of each device in order to meet the regulatory requirements the analytical effort for producers will increase in the same way as the product safety for the consumer does!“
MicroMol offers a wide range of safety tests and biocompatibility services for medical devices in accordance with the ISO 10993, the OECD guidelines and the demands of the European Pharmacopeia.
With capabilities to test many different types of medical devices for various therapeutic areas in parallel, MicroMol acts in close contact with the customers to design the most appropriate program for a special product. „Because of the fact that our Biocompatibility Unit is integrated in a sophisticated section for Cell- and Immune Analytics we offer a high level of quality and flexibility with rapid turnaround times. This is what our customers can expect!“, says Rudy.
MicroMol had focussed its activities in the field of biocompatibility / safety services to the following areas:
- Implementation of bridging studies aiming on the biological and scientific evaluation of a medical device (ISO 10993-2)
- Implementation of item specific test strategies
- Determination / exclusion of potential cytotoxix effects (ISO 10993-5)
- Determination / exclusion of potential irritative effects to the skin (ISO 10993-10)
- Determination / exclusion of potential irritative effects to the eye (OECD TG 460)
- Determination / exclusion of allergenic effects to the skin (ISO 10993-10)
- Determination / exclusion of pyrogenic effects (EP chapter 2.6.30)
- Determination / exclusion of genotoxic effects (ISO 10993-3)
- Cleaning validation of medical devices
- Sterility validation of medical devices
- Desinfection validation of medical devices
- Result based expert statement and certificate filing
The concept is rounded up by specialized microbiological testing strategies for the exclusion / determination of viable contaminating microorganisms and the identification of the contaminating microorganism (including bacteriophages) as well as their impact on other living organisms.
For more information visit: www.micromol.com