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Medicines, medical devices and bloodregulation and safety guidanceNotify MHRA about a clinicalinvestigation for a medicaldeviceFrom:

Medicines and Healthcare Products Regulatory AgencyFirst published:

18 December 2014Part of:

Regulatory guidance for medical devices, Clinical trials and investigations, Medicines,medical devices and blood regulation and safety, + others

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

1. How to notify MHRA of your clinical investigation2. Special circumstances for healthcare establishments3. More information4. See more like this

You may need to carry out a clinical investigation as part of theprocess to obtain a CE marking for your medical device. You

must inform MHRA if you are planning to do this at least 60 daysbefore starting your investigation.

How to notify MHRA of your clinicalinvestigationYou need to prepare your documents before you notify MHRA ofa proposed clinical investigation.

Required documentsPrint and sign the PCA1 and PCA2 forms on the integratedresearch application system (IRAS). Youll need to sign up toIRAS if you havent already.

Along with these forms you must include:

proof of payment for the notification application (copy of thepayment transaction or include a cheque with your submission)

a signed statement from the manufacturer declaring the devicemeets all of the legal requirements except for those they arecarrying out the investigation for

clinical investigation plan investigators 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, 453KB, 28pages) when preparing your notification application.Or see guidance on in vitro diagnostic investigations for medicaldevices (PDF, 133KB,15 pages) which are regulated asperformance evaluations.

FeesSee fees for clinical investigations and make a payment toMHRA for your notification before submitting it if you haventalready.

Submit your applicationYou must submit 8 copies of the full submission (all forms anddocuments) each on a separate CD. You need to include an indexon each CD.

Ensure all documents are:

in English (any other language must be translated and includedwith 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 named correctly and are legible

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

Dr Crina CacouRegulatory Affairs Manager (Medical Device Clinical Trials)Floor 4 Orange zone151 Buckingham Palace RoadLondonSW1W 9SZ

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

During the assessment experts will assess the safety andperformance of your device as well as the design of the clinicalinvestigation to be carried out. MHRA will write to you if werequire further information. We will write to you and offer ateleconference for a better understanding and to find a resolutionwithin the 60 day assessment time, if there are possible groundsfor objection.

A letter will be sent to you by the 60th day or before with adecision (objection or no objection) as to whether or not you cancarry out the proposed clinical investigation.

Special circumstances for healthcareestablishmentsYou dont need to notify MHRA of a clinical investigation if:

you have manufactured the medical device in house for yourown 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 organisationthat up until now has been manufactured in-house for patientsfor data to support safety and performance of a commercialproduct

See common scenarios for healthcareestablishments (PDF, 71.1KB, 1 page) which may be relevant toyou.

More informationSee information for clinical investigators (PDF, 129KB, 10pages) for what is required by clinicians involved in theinvestigation.Check the information on the biological safetyassessment (PDF, 107KB, 7 pages) for the scientific data youmust submit.Check guidance our assessors follow (PDF, 140KB, 10 pages) tosee how your notification is assessed.You can also see statistical considerations (PDF, 147KB, 12pages) for presenting statistical information for your clinicalinvestigation.See the guide on CE markings for more details on this and theEuropean Commissions website for guidance on classifications.If you have any questions before submitting your notification,email Dr Crina Cacoucrina.cacou@mhra.gsi.gov.uk or call 0203080 7338.Back to contentsPublished:

18 December 2014From:

Medicines and Healthcare ProductsRegulatory Agency

Part of:Regulatory guidance for medical devicesProtecting patients from avoidable harm

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This is part of a collection Regulatory guidance for medical devices

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