MHRA Revises Clinical Investigation Guidance in Line With EU MDR
Posted 30 July 2019 | By
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) revised 2013 medical device clinical investigation guidance to reflect the EU’s medical device regulation (MDR).
Revisions to MHRA’s guidance consider specific MDR changes, which were entered into force in 2017 and have a 26 May 2020 date of application. MDR is set to repeal the EU’s medical device directive (MDD), followed by the in vitro
diagnostic regulation’s (IVDR) 26 May 2022 repeal of the IVD directive.
The guidance points to the legislative provisions relating to biological safety evaluation under Annex XV of MDR, rather than Annex VII of MDD. The first set of revisions introduces the need for ensuring that the “anticipated benefits to the patients enrolled in the clinical trial justify the foreseeable risks,” in accordance with Article 62 of MDR, and submitting sufficient data for review to “provide assurance that all necessary toxicological risks have been appropriately considered.”
Several updates fall under toxicological risk assessments as the guidance not only reflects MDR changes, but also the 2018 version of the ISO 10993-1 standard on the biological and clinical evaluation of medical devices. “The extent of physical characterization required will be dependent on the medical device in question and is particularly important in the assessment of implants and blood contacting devices,” the revised toxicological risk assessment section says.
Other updates fall under conformity assessment requirements, underscoring the shift away from the previous essential requirements to MDR’s general safety and performance requirements. One update specifies a requirement in MDR that manufacturers must justify the inclusion of small amounts of substances classified as carcinogenic, mutagenic or toxic to reproduction, or substances whose endocrine disrupting properties provides risk to human health. Another applies to minimizing the risks posed by nanomaterials.
Revisions come as the UK nears the new 31 October Brexit deadline.
UK draft contingency legislation
for drug and device regulation was laid in Parliament last week. MHRA intends
to follow the same transitional periods as the EU for the application of MDR and IVDR in the event of a no-deal scenario.
Industry has cited Brexit as one of the many challenges to the MDR transition. BSI UK became the first notified body (NB) to be designated against MDR in January. But London-based Lloyd's Register Quality Assurance said
last month it will not apply to be designated against MDR nor IVDR “following recent market developments.” UL UK told Focus
earlier this month it “has not applied for designation under MDR/IVDR” and intends to support a EU27 NB, citing no-deal Brexit implications for NBs. SGS said in February it is undergoing the process to become MDR-designated. With less than nine months left, only two NBs have been designated so far.
Clinical investigations of medical devices – biological safety assessment