Medical devices have a vital role to play in healthcare. The term covers a broad spectrum of products that are crucial in diagnosis and treatment, disease prevention and monitoring and improving the quality of life of people suffering from disabilities. Many medical devices are relatively simple and familiar to all – for example, bandages and disposable gloves. Others are more complex – such as pacemakers, bone prostheses, dental fillings and cosmetic implants.
The medical device sector is growing rapidly. New medical devices are continually being designed and introduced to the marketplace. Many are designed to make some contact with the patient, be it directly or indirectly, and assuring compatibility between the materials used and biological tissues is a central tenet of the medical devices regulations. A thorough safety evaluation of any new device is, therefore, a vital step for successful product commercialisation.
Our application of good safety science can help manufacturers bring devices to market.
Currently, the key basis of the biological evaluation of medical devices is the set of standards developed by the International Organization for Standardization (ISO), known as ISO Standard 10993. This Standard provides a structured framework within a risk management process, that experts and other professionals can follow to effectively evaluate potential biological hazards. In Europe, Directives 93/42/EEC and 2007/47/EC, and the MEDDEV guidance are critical. In June 2016, US Food and Drug Administration experts published updated and highly-useful guidance for industry and internal regulatory staff, incorporating and elaborating ISO guidance (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf).
At bibra, we can carry out biocompatibility assessments in compliance with ISO 10993/FDA guidelines. Where there are data gaps for biocompatibility endpoints, we can help to determine whether waivers are appropriate, and review existing literature data relevant to such endpoints. We can also conduct comparative assessments of two ‘similar’ materials and prepare an opinion on their bioequivalence. Our toxicologists offer a vast amount of expertise and experience, from working closely with a diverse range of companies operating within this dynamic and active industry.
Clinical Expert Reports (CERs) – Medical Device Safety Assessment
With increasing focus on the CER in the safety assessment of medical devices, it is key to carry out
- Initial conformity assessments
- Post-marketing monitoring/assessments
The above (for which MEDDEV 2.7/1 rev 4 guidance is critical) could include such elements as:
- Critical interpretation of existing biocompatibility and clinical data on the specific device and on equivalent and similar devices
- Identification and critical evaluation of existing toxicology and human exposure data on individual device components, breakdown products and metabolites/degradants
- Provide rationales for waiving of tests on the basis of existing data
- Health risk assessments for components, additives, processing aids and potential leachables
In addition, bibra can:
- Provide advice on the selection of appropriate biocompatibility tests for a device
- Generate bridging reports from similar products or components
- Peer-review a company’s own Clinical Expert Reports for support, gap analysis and gap filling
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