MHRA Offers Draft Guidance on Health Institution Exemptions Under MDR/IVDR
Posted 23 January 2018 | By
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday sought comments on draft guidance on health institutions wishing to apply for an exemption to the new European in vitro diagnostic and medical device regulations (IVDR/MDR) and in particular, the provisions of Article 5, paragraph 5 in both regulations.
MHRA stresses in its introduction that the draft guidance "is not complete" as there are elements yet to be established, including harmonized standards, implementing acts and delegated acts, as well as elements where more information will be needed to establish the UK’s position.
"The use of exempted devices must be justified, the manufacture and use of the devices must be covered by a quality management system and some information about the device must be publicly available," the draft says.
Interspersed throughout the draft are questions for industry and other stakeholders, including some on whether the regulator is taking the right approach to the regulation of devices in clinical investigations and performance studies, and whether MHRA should reserve the right to impose review and reporting requirements for all serious incidents plus trend reporting of other incidents in the future.
Other questions even extend outside the scope of MDR/IVDR requirements, including: “Should MHRA require health institutions to employ/subcontract/have access to competent regulatory advisers in lieu of a Person Responsible for Regulatory Compliance?”
The draft also features sections on the transfer of devices, quality management systems, manufacturing, surveillance, governance, distance sales and control of subcontractors.
Open consultation: Health institution exemption for IVDR/MDR