The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) have updated their 2013 medical device clinical investigation guidance in line with the European Union’s (EU) medical device regulation (MDR). The guidance has been revised in accordance with specific MDR changes which entered into force in 2017, with the date of application 26th May 2020.
The guidance relates to the legislative provisions relating to biological safety evaluation under Annex XV of the MDR. In accordance with Article 62 of the MDR, revisions to the guidance introduce the requirement to ensure that “anticipated benefits to the patients enrolled in the clinical trial justify the foreseeable risks” and to submit adequate data for review to ensure that all the required toxicological risks have been appropriately considered.
The updated guidance not only reflects the MDR changes, but also the 2018 version of the ISO 10993-1 standard on the biological and clinical evaluation of medical devices, therefore a number of updates to the guidance relate to toxicological risk assessments. The revised section on toxicological risk assessment states that “the extent of physical characterisation required will be dependent on the medical device in question and is particularly important in the assessment of implants and blood contacting devices”.
Additional updates fall under the conformity assessment requirements, and highlight the shift away from the previous essential requirements to the MDR’s general safety and performance requirements. A requirement in MDR is that manufacturers must justify the inclusion of small amounts of substances which are classified as carcinogenic, mutagenic or toxic to reproduction, or substances whose endocrine disrupting properties are a risk to human health.
The UK draft contingency legislation for medicine and device regulation has now been laid in Parliament. Furthermore, in the event of a no-deal Brexit, the MHRA plans to follow the same transitional periods as the EU for the application of MDR and in vitro diagnostic medical devices regulation (IVDR).
To read the updated MHRA guidance on clinical investigations of medical devices – biological safety assessment, please click here.