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Clinical investigations — access pathways

Clinical investigations as a special access pathway​

Medical devices that have not completed conformity assessment — and therefore do not bear the UKCA or CE mark — may be used in clinical investigations in the UK for the purpose of collecting the clinical data needed for conformity assessment.

This is not the same as commercial market access — the investigational device may only be used within the approved clinical investigation, on enrolled subjects who have provided informed consent.

Key requirements for investigational device access​

  1. MHRA notification — submit a notification to MHRA before the investigation begins (for most pre-market investigations of unmarked devices)
  2. Ethics committee approval — NHS REC (Research Ethics Committee) approval is required for all clinical investigations involving human subjects
  3. Investigational marking — the device bears an investigational marking (not UKCA) confirming it is for investigational use only
  4. Protocol compliance — the device may only be used according to the approved protocol
  5. Adverse event reporting — any serious adverse device effects must be reported to MHRA promptly

Compassionate use (named patient use)​

In individual cases where a patient with a life-threatening or serious condition has no other treatment options, MHRA may facilitate access to an investigational device on a named-patient basis outside of a formal clinical investigation. This is handled case-by-case and requires clinical justification.

Official references​

ReferenceDescription
UK MDR 2002Clinical investigation provisions
ISO 14155:2020GCP for clinical investigations
MHRA: Clinical investigations guidanceMHRA clinical investigation guidance

Expand the 'MHRA notification' bullet point to clarify:

MHRA notification — submit a notification to MHRA before the investigation begins (for most pre-market investigations of unmarked devices). The notification should include: • Protocol summary (objectives, design, patient population) • Investigator qualifications and ethics committee approval reference • Preliminary safety and performance data • Device description and labelling (investigational marking) • Risk assessment relevant to the investigational use MHRA typically issues confirmation within 10 working days (or may request additional information). Investigations must not commence until MHRA confirmation is received.