Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

• Devices that are made or modified and used within a health institution do not need to meet all the requirements of the IVDR • HIE can only be used within the same legal entity (see MHRA guidance on final slide) • Exempt devices must: • Meet the relevant requirements for safety and performance (performance studies?) • Have a justification for the exemption based on target patient group’s specific need • Have formal technical documentation in place • Be made and used within an appropriate quality system • Have some information made publicly available Health institution exemption (HIE) is applicable to CDx

The Organisation for Professionals in Regulatory Affairs

15

Co-development

Marketing Authorisation

Medicines legislation

Phase I trial

Phase II/III trial

Medicines Authority review

Medicines Authority opinion Medicines Authority review

Devices Authority review/ notification

Notified Body review

Planned Devices Regulation

Clinical performance study

CE mark (Companion Diagnostic)

Analytical study

The Organisation for Professionals in Regulatory Affairs

16

8