Why is one application not enough?

Hybrid studies, such as the evaluation of a drug-eluting stent or a cell-therapy delivery system, have long posed a regulatory challenge, since they fall under two distinct legal regimes at once: the rules governing clinical trials of medicinal products and the MDR provisions on clinical investigations of devices. MHRA reminds applicants that such situations require submission through the Parallel Review route – a name that has replaced the earlier term “combined trial of an investigational medicinal product and an investigational medical device.” The Agency openly acknowledges that the process has historically been perceived by applicants as complex, and states that it is gathering ongoing feedback with the aim of simplifying it further – ultimately in coordination with the Health Research Authority (HRA) and the developing Plan and Manage Health and Care Research service.

Before you open the forms

The starting point is confirming that the study genuinely meets both definitions at once. MHRA points applicants to two separate verification routes: the guidance on clinical investigations of medical devices (together with accompanying flow charts) and the guidance on when a Clinical Trial Authorisation (CTA) is required for a medicinal product. Only once both conditions are confirmed does launching a Parallel Review make sense; where doubt remains, MHRA recommends contacting CI-applications@mhra.gov.uk before a sponsor invests time in preparing the full documentation package.

Five steps, and the order matters

  1. Completing the MHRA Devices form in standard IRAS. The sponsor creates a new project in the “old” IRAS system solely to generate this document – selecting the “Ionising Radiation and Devices” form (even where the project does not involve ionising radiation) and the MHRA Devices Division form. The IRAS ID generated this way serves a purely technical purpose – the correct study identifier remains the seven-digit reference number issued in the new part of IRAS.
  2. Pre-application Devices Validation. The sponsor contacts the MHRA Devices team requesting a ShareFile link to submit documentation, with “Devices Pre-Validation, ShareFile request” in the email subject line. This is not yet a substantive review, merely a check of the completeness of the document package.
  3. Uploading the MHRA Devices form together with the CTIMP documentation in the new part of IRAS. This is where a common pitfall arises, one MHRA specifically flags: documents required by both the Research Ethics Committee (REC) and MHRA Devices, such as the participant information sheet (PIS), must be uploaded twice, once as “Miscellaneous: MHRA only,” and both copies must be identical.
  4. Responding to Requests for Further Information (RFIs). RFIs from MHRA Medicines and the REC arrive through IRAS in the usual way; RFIs from MHRA Devices are handled exclusively by email, outside the system. The sponsor should not respond to the MHRA Medicines RFI until all RFIs from MHRA Devices have been closed and explicit instruction has been given that a response can now be submitted.
  5. Receiving an outcome. Because of the differing statutory timeframes of the two legal regimes, the sponsor will receive two separate decisions, not one.

A short glossary

  • MHRA Devices – formerly the Clinical Investigations team, assessing only the medical device component of the application;
  • MHRA Medicines – the Clinical Trials team, assessing the CTIMP component together with the REC;
  • Pre-validation – an informal check of the completeness of device documentation before formal submission, not to be confused with a substantive review;
  • RFI (Request for Further Information) – a formal request for additional information or clarification, issued separately by each team.

Timeline

This is the most practically important part of the guidance, and worth unpacking step by step, since a mistaken assumption of a shared deadline is the most common source of misunderstanding between sponsors and MHRA. CTIMP application validation occurs within 7 calendar days of submission. From that point, MHRA Medicines has 30 days to assess the CTIMP documentation, while MHRA Devices has 60 calendar days from receipt of a valid application to issue a decision or an RFI on the device component. Under the Parallel Review process, an RFI from MHRA Medicines is always issued, even where it would not formally be necessary, precisely to align the timelines of the two review tracks. If the sponsor receives a clinical-trial RFI, they typically have 60 days to respond, and MHRA Medicines then assesses that response within a further 10 days. In a typical scenario involving an RFI, this means a full, joint decision may land around day 100 from CTIMP submission, though MHRA is explicit that any extension to an RFI response deadline shifts this timeline accordingly.

Changes during the study also require dual handling

Modifications affecting only the device component are called “amendments” and are submitted exclusively to MHRA Devices; changes affecting the CTIMP or ethics component — “modifications” — go to MHRA Medicines and the REC through their own separate channels. Where a change affects both components at once, the sponsor must submit parallel notifications through both routes, ensuring duplicated documents remain fully consistent with one another, exactly as with the original application.

Beyond the study itself, it’s worth remembering that a successful Parallel Review outcome authorises the clinical investigation — it is not the same as placing the device on the UK market. Once the device has completed its investigational stage, manufacturers still need to complete separate medical device and IVD registration in the UK, including UKCA marking and, for manufacturers based outside the UK, appointing a UK Responsible Person (UKRP).

Link to the document: Parallel Review applications for an investigational medicinal product study and an investigational medical device study – MHRA, July 2026