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, and close partnerships with analytical and testing laboratories and regulatory experts, we are the ideal partner for assessing the toxicological safety of your 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 expert at conducting biocompatibility assessments, 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 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

ISO 18562 evaluation of a medical device in contact with the breathing gas pathway

Case study

As part of a large programme of work in evaluating the safety of a new endotracheal tube device, bibra was asked to evaluate the health risks posed by exposure to potentially hazardous substances that may be transferred to the patient via the gas stream during device use.

Biocompatibility review under ISO 18562 guidelines

Case study

The client commissioned bibra to review a biocompatibility report following feedback from US FDA.

Toxicological risk assessment of leachables from a combination product

Case study

The client was developing a ready-to-use (RTU) process for the administration of a viral-based product in a clinical setting. Bibra was requested to assist with the assessment of extractables during the development phase and leachables in the final RTU process - viral vector product.

Biocompatibility evaluation of a series of autoinjector medical devices

Case study

The company manufactures a range of parts for use as components in a variety of medical devices.

Toxicological risk assessment of leachables from a syringe medical device

Case study

The company had commissioned leachables studies on a syringe medical device intended for flushing of intravenous catheters/tubing with saline. The leachables profile was examined at two time points (day 0 and about 2 months) and numerous substances were detected at low concentrations.

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