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.
A notification to MHRA will not be required for medical devices that are CE marked for the purpose under investigation.
Christmas period 2016
Manufacturers 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.
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.
You must include at least the following documents in your submission:
- cover letter including:
- an explanation of the purpose of the clinical investigation
- confirmation of whether the same device has been the subject of previous notifications to MHRA
- MHRA reference numbers for any previous notifications
- confirmation of whether any subsequent modifications have been made to the device or whether the device remains unchanged from the previous notifications
- signed PCA1 form, PCA2 form and sterilisation annex generated from the integrated research application system (IRAS). Note that you will need to sign up to IRAS if you haven’t already in order to generate these forms. Please print, sign and scan these forms and include them on the CDs. An additional version of the PCA forms with no signature (a pdf version not scanned) is recommended to facilitate the review of your application.
- proof of payment of the MHRA fee (provide a copy of the payment transaction or include a cheque with your submission)
- details of who to invoice (full company name, address and registered tax/VAT number)
- clinical investigation plan
- investigator’s brochure
- patient information
- patient Consent
- CVs for UK clinical investigators
- detailed information on the device and its accessories (if any) such as intended purpose, drawings etc.
- essential requirements checklist
- risk analysis
- instructions for use
- device labels
- summary of all bench testing and pre-clinical testing conducted
- summary of all clinical experience with the device to date
- end of study reports (for any concluded clinical investigations that involved the same medical device under investigation)
- list of standards met
- sterilisation validation report (where relevant)
- software information – to address p26-27 of our guidance for manufacturers (where relevant)
- biological safety assessments of patient contacting materials – see our biological safety assessment guidance (where relevant)
- information on animal tissues - see appendix 2 of our guidance for manufacturers (where relevant)
- research ethics committee opinion (if available)
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.
Submit your application
You must submit 3 copies of the full submission (all forms and documents) each on a separate CD. Please submit 1 extra CD for each of the following (making a total of up to 6 CDs where necessary):
- where animal tissues have been utilised
- where the device is patient contacting
- where non CE marked software is being used (for stand-alone software and all devices that incorporate software)
Notifications will be only be considered valid if:
- they include the required documents listed above
- all documents are labelled as separate attachments on the CDs with titles reflecting the content (i.e. clinical investigation plan, essential requirements checklist, instructions for use, investigator’s brochure, patient informed consent, risk analysis, sterilisation validation report, summary of pre-clinical data).
- all attachments are provided in English (any other language must be translated and included with the original version as a separate document)
- all attachments are searchable (do not include pdfs of scanned documents)
- all information is legible
Please include an index on each CD and avoid using several subfolders in your submission.
Regulatory Affairs Manager (Medical Device Clinical Trials)
Floor 4 orange zone
151 Buckingham Palace Road
When MHRA has received your documents and validated them, we will write to you within 5 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. Day 1 of the 60 days is taken as being the first working day that follows the date of receipt of a valid Notification.
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
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 email@example.com or call 020 3080 7363.
Published: 18 December 2014
Updated: 21 October 2016
- Updated guidance
- Added information about Christmas period 2016
- Added clarification around the start of the 60-day assessment timeframe.
- Information on Health Research Authority Approval
- Updated guidance for manufactures on legislation for clinical investigations of medical devices.
- First published.