According to the MHRA, a biological risk assessment is required for medical devices to conform to the EU Regulation for Medical Devices 2017/745 (MDR). The Agency has therefore released a guidance document on how to conduct and document such an assessment. With reference to ISO 10993-1:2018, the MHRA noted that recommended endpoints for consideration in the assessment should not be interpreted as a list of required biological tests to be carried out, rather, these endpoints should be addressed in a written evaluation. Moreover, the MHRA encourages device manufacturers to establish a “complete chemical fingerprint” of the final device and to conduct a toxicological risk assessment of the constituent chemicals, where possible. If a detailed chemical characterisation is not possible, extraction testing could be considered, and the resulting extractables profile can then undergo toxicological risk assessment.

Medicines and Healthcare products Regulatory Agency (2019). Guidance on legislation. Clinical investigations of medical devices – biological safety assessment. July 2019.


The above items were taken from the December 2019 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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