Medical Devices
Our work
There are over half a million medical devices available on the UK and European markets, covering everything from in vitro diagnostic devices, surgical instruments and implants to contact lenses and wheelchairs. With recent regulatory changes – the introduction of the UKCA mark in Great Britain and the Medical Devices Regulation coming into force in Europe – companies are faced with a daunting task to ensure continuing compliance. Thanks to our extensive expertise in medical device toxicology, and close partnerships with analytical and testing laboratories and regulatory experts, we are the ideal partner for assessing the safety of your medical devices.
Biocompatibility of medical devices
The basis for the biological evaluation of medical devices is the ISO 10993 family of international standards. This provides a framework for the chemical characterisation, biological testing and toxicological risk assessment (TRA) of medical devices. We are experts at conducting biocompatibility assessments concerning medical devices, reviewing new or existing test data and conducting TRAs (in line with ISO 10993-17) based on analytical studies. Using the ISO standards and other guidance published by regulators including the US FDA and European Commission, we can provide an evaluation of the full range of endpoints required.
Extractables and Leachables
The health risk assessment of extractable or leachable chemicals that can migrate from medical devices (and subsequently reach the patient) is critical part of establishing biological safety. Within the ISO 10993 framework, extractables and leachables (chemical characterisation) studies play a critical role in understanding the composition of a medical device.
Change Control
When a single component of a medical device undergoes a change – for example, a different source of a raw materials – it is necessary to evaluate the impact this will have on patient safety. We are very experienced in carrying out the sort of comparative assessments and concluding on their bioequivalence.
Our Expertise
Our team has been at the forefront of the medical device E&L sector for many years. Pete Watts, one of our Toxicology Directors, and Senior Toxicologist, Chris Waine, are regular presenters at E&L conferences. Chris is also an expert member of the BSI and ISO committees developing the 10993 series of standards for the biological evaluation of medical devices, including E&Ls testing and toxicological risk assessment - read more about the newly released International Standard ISO 10993-17 in our blog post.
Our expertise in this area
Hazard Characterisation
Our hazard assessments, generally based on in-depth searches of the scientific literature, aim to define the dose-response for all routes of each of a chemical’s toxicological propensities.
Risk Assessment
Our health risk assessments convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure.
Testing Strategies
We can offer advice on the practicalities of designing a testing programme and will support you from approving the protocols to reviewing the final reports.
Some of our case studies in this area
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
