Medicines, medical devices and blood regulation and safety – guidance

Notify MHRA about a clinical investigation for a medical device

How to notify MHRA of your intention to carry out a clinical investigation for a CE marking.

You may need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device. You must inform MHRA if you are planning to do this at least 60 days before starting your investigation.

How to notify MHRA of your clinical investigation

You need to prepare your documents before you notify MHRA of a proposed clinical investigation.

Christmas period 2016

Manufactures are advised that MHRA will not be accepting notifications for clinical investigation or study amendments during the period 19th December 2016 – 2nd January 2017 (inclusive). Any notifications received during this period will be processed in the new year and the 60 day assessment periods will start from 4th January 2017 for valid clinical investigation notifications.

Any notifications received before 20th December 2016 will be processed as normal and there will be no interruption to the 60 day process over the Christmas period.

Required documents

Print and sign the PCA1 and PCA2 forms on the integrated research application system (IRAS). You’ll need to sign up to IRAS if you haven’t already.

Along with these forms you must include:

  • proof of payment for the notification application (copy of the payment transaction or include a cheque with your submission)
  • a signed statement from the manufacturer declaring the device meets all of the legal requirements except for those they are carrying out the investigation for
  • clinical investigation plan
  • investigator’s brochure
  • patient information
  • patient consent
  • essential requirements checklist
  • summary of pre-clinical data
  • sterilization validation report
  • risk analysis
  • instructions for use etc.
  • detailed information on the device and its accessories (if any) such as intended purpose, drawings etc.
  • research ethics committee opinions

Follow the guidance for manufacturers (PDF, 473KB, 28 pages) when preparing your notification application.

Or see guidance on in vitro diagnostic investigations for medical devices (PDF, 133KB, 15 pages) which are regulated as performance evaluations.

Fees

See fees for clinical investigations and make a payment to MHRA for your notification before submitting it if you haven’t already.

Submit your application

You must submit 8 copies of the full submission (all forms and documents) each on a separate CD. You need to include an index on each CD.

Ensure all documents are:

  • in English (any other language must be translated and included with the original version as a separate document)
  • numbered and in their correct sequence including reprints, diagrams, tables and other data
  • labelled as separate files on the CDs with titles reflecting the content (eg clinical investigation plan, essential requirements checklist, instructions for use, investigator’s brochure, patient Informed consent, risk analysis, sterilization validation report, summary of pre-clinical data)
  • are legible

Submit your CDs at least 60 days before the proposed clinical investigation by recorded delivery to.

Daniella Smolenska
Regulatory Affairs Manager (Medical Device Clinical Trials)
Floor 4 orange zone
151 Buckingham Palace Road
London
SW1W 9SZ

Assessment

When MHRA has received your documents and validated them, we will write to you within 2 working days to confirm that the 60 day assessment has started or we will let you know If there are any issues. If there are any issues raised, the 60-day assessment will start when we receive a valid response.

During the assessment experts will assess the safety and performance of your device as well as the design of the clinical investigation to be carried out. MHRA will write to you if we require further information. We will write to you and offer a teleconference for a better understanding and to find a resolution within the 60 day assessment time, if there are possible grounds for objection.

A letter will be sent to you by the 60th day or before with a decision (‘objection’ or ‘no objection’) as to whether or not you can carry out the proposed clinical investigation.

Special circumstances for healthcare establishments

You don’t need to notify MHRA of a clinical investigation if:

  • you have manufactured the medical device in house for your own patients with no objective to place it on the market

You may need to notify MHRA of a clinical investigation if:

  • you want to provide a medical device to another organisation that up until now has been manufactured in-house for patients for data to support safety and performance of a commercial product

See common scenarios for healthcare establishments (PDF, 71.1KB, 1 page) which may be relevant to you.

Heath Research Authority (HRA) approval

HRA Approval is the new process for applying for approvals for all project-based research in the NHS led from England and replaces previous systems including the NIHR Coordinated System for gaining NHS Permission (CSP).

HRA Approval brings together the assessment of governance and legal compliance, undertaken by HRA, with the independent REC opinion provided through the UK research ethics service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England.

More details about how to apply, how to open new sites for pre-HRA Approval studies, and how to submit amendments for all studies where the lead NHS R&D office is in England can be found here

More information

See information for clinical investigators (PDF, 129KB, 10 pages) for what is required by clinicians involved in the investigation.

Check the information on the biological safety assessment (PDF, 107KB, 7 pages) for the scientific data you must submit.

Check guidance our assessors follow (PDF, 140KB, 10 pages) to see how your notification is assessed.

You can also see statistical considerations (PDF, 147KB, 12 pages) for presenting statistical information for your clinical investigation.

See the guide on CE markings for more details on this and the European Commission’s website for guidance on classifications: Section 2.4 - Classification of MD (June 2010).

If you have any questions before submitting your notification, email Daniella Smolenska daniella.smolenska@mhra.gsi.gov.uk or call 020 3080 7363.