Guidance

Submitting a clinical investigation proposal for MHRA assessment

Published 31 March 2026

This guidance applies to all clinical investigations being conducted in the UK, however, the rules for notifying the MHRA of a clinical investigation in Great Britain (England, Wales and Scotland) differ from those applicable to Northern Ireland.

Clinical investigations being conducted in Great Britain and not Northern Ireland need to meet the requirements of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

The Northern Ireland Protocol required Northern Ireland to continue to align with EU rules for devices after 1 January 2021. Therefore, the Medical Device Regulation (EU) 2017/745 (EU MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) applied in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline.

This means that clinical investigations being conducted in Northern Ireland must meet the requirements of the EU MDR and be submitted to MHRA in accordance with these regulations.

Where a clinical investigation includes sites in both Great Britain and Northern Ireland, submission to MHRA must be made in line with the requirements of the EU MDR. By meeting the EU MDR, requirements of the UK MDR for clinical investigations are deemed to be satisfied. Therefore, a single application made to MHRA under the EU MDR will cover any sites proposed in both Great Britain and Northern Ireland for the same clinical investigation.

You can find out more about the regulation of medical devices in Northern Ireland.

We also have guidance on how to register medical devices.

MHRA fees

For all clinical investigation notifications, a charge will be made by the MHRA to the manufacturer for the assessment of a proposed clinical investigation as detailed in the UK Medical Devices Regulations 2002: regulation 56 (as amended by SI 2017 No. 207).

The relevant fee should be paid upon receipt of an invoice from MHRA.

Devices are categorised according to risk as a group A or B device:

• group A includes Class I, IIa, and IIb devices, other than implantable or long term invasive devices
• group B includes Class IIb implantable or long-term invasive, Class III and active implantable devices

You can find out more about our fees and current charges.

If you withdraw a notification for a clinical investigation within 5 days of the MHRA receiving it, 50% of the relevant fee will be charged. If you withdraw after 5 days, the full fee will be charged.

Prior to notifying the MHRA of a clinical investigation

A very common reason for the MHRA objecting to a clinical investigation is the failure of the manufacturer to supply the necessary data within the statutory assessment time period.

The information described in this guidance should be provided as part of the clinical investigation submission to support claims of compliance with the essential requirements or the General Safety and Performance Requirements. It is therefore necessary that the device under investigation has been manufactured and tested for safety and performance prior to an application being made to the MHRA.

For clinical investigations involving only Great Britain, you must have all the information necessary to demonstrate compliance with all the relevant essential requirements (except for those that are the subject of the investigation) as listed in Part II of the UK MDR, Annex I (as modified by Part II of Schedule 2A to the UK Medical Devices Regulations 2002).

For clinical investigations involving Northern Ireland, you must have all the information necessary to demonstrate compliance with all the relevant General Safety and Performance Requirements (except for those that are the subject of the investigation) as listed in Annex I of EU MDR.

How to apply

Applications must be made on the Integrated Research Application System (IRAS).

You must complete the application form on IRAS and upload the relevant supporting documents. Follow the instructions on IRAS on how to submit the application.

If you have general queries about the submission process on IRAS, you can email the Clinical Investigations Team at info@mhra.gov.uk.

Technical questions on IRAS should be submitted to the IT helpdesk for IRAS by emailing helpdesk@myresearchproject.org.uk.

All information must be in English. If any part of the supporting data consists of material in another language, this must be translated before submission.

You should ensure that complete copies of all documents are provided and all information is provided in a readable format (for example, not too small to see full rows and ensure no text is truncated). All text and any relevant drawings and their captions must be clear and legible.

Documents should ideally be provided in PDF format and, where possible, be searchable. Please do not include compressed PDFs or scanned documents.

For clinical investigations involving only Great Britain only, the 60-day assessment period will commence once a valid notification is received by the MHRA. Day 1 of the 60 days is taken as being the first working day that follows the date of receipt of a valid Notification. Validation will be confirmed within 5 working days and where a notification is found to be invalid the 60 days will not commence.

For clinical investigations involving Northern Ireland, when MHRA has received your documents and validated them, we will write to you within 10 calendar days to confirm that the application is valid and the assessment has started or we will let you know if there are any issues. If there are any issues we will confirm these in writing and provide a 10-day deadline for a response. The assessment will not start until we have received a valid response. If, after receipt of the response or the 10-day deadline has expired, the application is still considered to be invalid we will write to confirm this within 5 days.

Day 1 of the MHRA assessment is taken as being the date that we confirm that we have received a valid application.

IRAS Form and supporting documentation required

The checklist tab on IRAS contains a list of all documents that should be included in the submission to MHRA. They are:

• covering letter on headed paper

•  clinical investigation plan

•  investigator’s brochure

• participant information sheet

• participant consent form

• CVs for UK clinical investigators

• device details

• essential requirements checklist or General Safety and Performance Requirements checklist

• risk analysis

• instructions for use of a medical device

• 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 (where relevant)

• biological safety assessments of patient contacting materials (where relevant)

• information on animal tissues (where relevant)

• information on any medicine or human blood derivative, or non-viable human tissues and cells incorporated into the device

• research ethics committee opinion (if available)

This information should be provided as part of the clinical investigation submission to support claims of compliance with the essential requirements or general safety and performance requirements.

Documentation required for all applications

Covering letter on headed paper

As a minimum, your cover letter should include:

• an explanation of the purpose of the clinical investigation

• confirmation of whether the study is First In Human, Pilot or Feasibility, Pivotal or Confirmatory, or Post Market and provide the rationale and justification for this

• confirmation of whether the study has commenced in other countries. Where this is the case provide details of the status, duration and known outcomes of the study to date

• confirmation of whether the same device has been the subject of previous notifications to the MHRA

• the 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

• information addressing any previous application where the MHRA gave grounds for objection, including detailed information on how you addressed the grounds for objection, clearly showing which documentation is the same as the previous submission and a tracked-changes version and a clean version of new documentation

• details of any objections received to a study involving the investigational device in any other country, including the grounds for this objection

• for Post Market Studies with a clinical site planned in Northern Ireland, a list of all the procedures considered to be additional to the normal conditions of use of the device, that are also invasive or burdensome

• confirmation of whether the manufacturer, sponsor and any individuals involved in running of the study have any connections with MHRA personnel, if this is the case, you should provide further details.

We will use MHRA expert assessors to review the application. We may also use assessors from outside the MHRA who will have signed a statement of confidentiality incorporating a declaration of any conflicts of interest. You may name the institutions and individuals whom you do not wish to act as assessors for the investigation in question and provide a rationale for this. The MHRA will, so far as possible, bear such views in mind when appointing assessors.

Clinical investigation plan

A copy of the clinical investigation plan must be provided, which should be in line with ISO14155:2020.

The following information should either be included in the clinical investigation plan or within other documents submitted to the MHRA:

• names and addresses of the institutions in which the clinical investigation will be conducted

• a signed copy of the signature page for the clinical investigation plan signed by all UK investigators

• a description of intended purpose and mode of action of device

Investigation parameters and design

• aims and objectives of clinical investigation (bearing in mind which essential requirements or general safety and performance requirements are being addressed by the clinical investigation in question)

• a clear description of the type of study design (for example, single-arm or controlled, parallel group or crossover) and purpose of the study (feasibility or confirmatory)

• details of the type of randomisation to be used (for example, simple, block, stratified, minimisation) - if stratified randomisation or minimisation is used, the stratification or minimisation variables should be listed, if applicable

•  the study classification (for example, a superiority trial to show that the test device is superior to the comparator, an equivalence trial aiming to show that two treatment arms only differ by an amount which is clinically unimportant, or a non-inferiority trial to demonstrate that the test device is not clinically inferior to the comparator), if applicable

• details of the approach to blinding (for example, double-blind, single-blind or open label) with justification, if applicable

• sample size with justification - see section 1.2 of our guidance on statistical considerations - even in a first-in-human, pilot or feasibility study which does not propose to test a formal hypothesis it should be justified that the proposed sample size is suitable for the purpose of the study

• number of centres participating in the study, with justification

• duration of study with start and finish dates and proposed follow-up period, with justification.

• criteria for patient selection, including the inclusion and exclusion criteria (with justification and any age limits specified), and the criteria for withdrawal.

• description of the generally recognised methods of diagnosis or treatment of the medical condition for which the investigational testing is being proposed

• where applicable, details of any proposed post-market clinical follow-up plan and provision of long-term safety and performance data of the device under investigation

• consideration should be given to adding a section on how the study will be conducted during a global pandemic, regional epidemic or natural disaster

Data collection, analysis and statistics

• description of end points (primary and secondary) and the data recorded to achieve the end points, method of patient follow-up, assessment and monitoring during investigation

• the analysis populations to be used

• the hypotheses which are to be tested and/or the device performance characteristics which are to be estimated in order to satisfy the objectives of the clinical investigation, including details of the statistical methods to be used to accomplish these tasks should be described for the primary (and preferably the secondary) variables

• the significance level to be used for any statistical tests, and whether this is 2-sided or 1-sided.

• methods for handling missing data should be stated, with sensitivity analyses to assess the impact of missing data, if appropriate

• description of procedure and details of data to record and repost serious adverse events and adverse device related incidents (in line with the requirements of MEDDEV 2.7/3 or MDCG 2020-10/1)

You should also include a description of all interim analyses planned and their timing and purpose (for example, stopping for futility or efficacy). Details of the statistical analysis of the interim data, along with precise rules for which actions will be taken and the results that would lead to those actions (for example, the trial will be stopped for efficacy if 2-sided) p<0.001 at the interim analysis). Details of how the type I error of the final analysis will be adjusted to account for the interim analysis. In the case of unblinded interim analysis, details of how dissemination of the results will be restricted to preserve the integrity of the trial.

You can find out more about statistical considerations in clinical investigations

Clinical investigator’s brochure

A copy of the investigator’s brochure must be provided, which should be in line with ISO14155:2020.

The following information should either be included in the investigator’s brochure or within other documents submitted to the MHRA:

• reference to important relevant scientific literature (if any) with an analysis and bibliography

• classification of device with rationale

• brief description of device and its intended use together with other devices designed to be used in combination with it

• design drawings, diagrams of operation and diagrams of components, sub-assemblies, circuits and other elements, including descriptions and explanations necessary to understand any drawings and diagrams

• photographs (preferably in colour)

• details of any comparable device on the market

• identification of any features of design that are different from a previously similar marketed product (if relevant)

• details of any new or previously untested features of the device including where applicable, function and principles of operation

• summary of experience with any similar devices manufactured by the company including length of time on the market and a review of performance related complaints

• summary of the risk benefit analysis to include identification of hazards and estimated risks associated with the manufacture (including factors relating to device design, choice of materials, software) and the use of the device (ISO 14971:2019), together with a description of what actions have been taken to minimise or eliminate the identified risk

• description of materials coming into contact with the body, why such materials have been chosen, and which standards apply (if relevant)

• identification of any special manufacturing conditions required and if so how such requirements have been met

• description of the methods of manufacturer, in particular the sterilisation and identification of packaging used for sterilisation of device

• summary of the relevant standards applied in full or in part, and where standards have not been applied, descriptions of the solutions adopted to satisfy the essential requirements or general safety and performance requirements

• the results of the design calculations and of the inspections and technical tests carried out

• any provisions been made by the manufacturer for the recovery of the device and subsequent prevention of unauthorised use, including procedures for analysis of implantable devices following explant

• identification of any tissues of animal origin

• identification of a substance (medicinal product), human blood derivative or non-viable human tissues and cells incorporated with the device as an integral part

• details of training for users (both healthcare professionals and patients)

Participant information sheet

Participant information should identify and explain all risks to participants in plain English.

Participant consent form

You should include a copy of the participant consent form.

CVs for the UK clinical investigators

The CVs should include the names, qualifications, addresses of clinical investigators and of principal clinical investigator for a multi-centre clinical investigation, together with summary of experience in clinical studies and in the specialist area concerned and the necessary training and experience for use of the device in question.

You should also provide evidence of GCP certification.

Device details

The depth of detailed information supplied with the notification should be appropriate to the classification of the device, novelty of design, materials used and risks associated with the device.

You should provide:

• a detailed description of device, how the device is assembled and how the constituent parts are joined together

• a list of accessories, principles of operation and block or flow diagram of major components

• principal design drawings and circuit diagrams, together with a description and explanations necessary for the understanding of the said drawings and diagrams

• a picture or schematic illustration of the device operation and photos of the device

• a video demonstrating the operation of the device if available

• for device systems you should provide a summary of how compatibility of all device components (whether UKCA or CE marked or not) has been determined, including an updated risk analysis covering this

• for UKCA or CE marked devices being used for a new intended purpose that is not covered by the existing UKCA or CE marking you should provide full details of the new intended use and how this compares to the original intended use

For UKCA or CE marked devices being used as ‘ancillary’ devices within the study:

• ensure the devices are being used in accordance with the UKCA or CE marked instructions for use

• provide evidence that the safety profile of such devices has been assessed to ensure there are no current safety concerns - this assessment should, as a basic step, involve a search of any safety notices published by the manufacturer or MHRA

Essential requirements and general safety and performance requirements checklist

The checklist should detail how these requirements have been addressed, including references to designated or harmonised standards as appropriate.

You should include:

• evidence of how applicable standards have been met

•  copies of all test reports and other documents referenced in the checklist within the submission to MHRA

Risk Analysis

You should provide a risk analysis, preferably to EN ISO 14971:2019.

For device systems the risk analysis should cover compatibility of all device components (whether UKCA or CE marked or not).

Devices incorporating an ancillary medicinal substance the risk analysis should cover compatibility between the medicine and the device materials.

Instructions for use of medical device

These are required for all investigational device components. You should include, where relevant, information on setup of the equipment for use with a patient and any pre-use checks that may be required.

Device Labels

You should provide copies of the labels for the investigational device. The wording on the labels should state that the device is ‘Exclusively for clinical investigations’.

Summary of all bench testing and pre-clinical testing conducted

You should include:

• a summary of all bench testing conducted, the results obtained and the manufacturer’s conclusions with details of which device model and version was involved

• a justification for choice of each bench test performed, reference to the specific standard where the test is stipulated (where relevant) and whether the test has been adapted in any way

• where equivalence is claimed, provision of supporting data should cover the clinical, technical and biological aspects of the device in line with MEDDEV 2.7.1

• results of design calculations

• acceptance criteria for testing (for example, tensile strength and stiffness)

• confirmation of whether each device will be individually tested for conformance to the design criteria after manufacture

• a summary of all testing conducted in animals or ex vivo, the results obtained and the manufacturer’s conclusions. Include a justification for the number and species of animals used and any non-animal models tested. For implantable devices include detail on the condition and integrity of the device at explant and histopathological results. Studies conducted should be in accordance with ISO 10993.

• a summary of any testing conducted to address human factors and usability engineering.

Summary of clinical experience with the device to date

This should include adverse events seen and performance related complaints, including number of complaints of each type and the root cause in each case.

Confirmation of whether the device involved was identical to the investigational device intended to be used in the proposed clinical investigation. If not, provide full details of how the new device differs. Detail changes to the design, materials, intended use and the rationale for these changes. Provide information on all First in Human and Pivotal Trials, irrespective of the place and time of the study and the results.

List of standards met

You should:

• list all designated or harmonised standards that the device complies with including year of issue

• if the standards are only met in part, provide a description of solutions adopted to meet the essential requirements of the UK MDR or general safety and performance requirements listed in Annex I of the EU MDR

• provide a full justification for where the standards met have been superseded

The application of designated or harmonised standards is voluntary and applicants may choose alternative methods of demonstrating compliance with the essential requirements. For example, compliance with international, national or in-house standards. You should provide a full justification where such alternative methods have been chosen.

A copy of the ethics committee opinion

You should provide a copy of the committee’s opinion, whether fully or partially approved, or approved with conditions to the MHRA at the time of submission if it is available.

If it is not yet available, a copy should be sent as soon as the committee’s report has been received.

Documentation required in specific circumstances

Sterilisation validation report

The MHRA requires manufacturers of sterile devices, which are either provided sterile or sterilised at the point of use, to submit suitable documentation to demonstrate that the method of sterilisation renders the device sterile.

The Clinical Investigation Application form on IRAS has been designed to assist manufacturers in setting out the information required by the MHRA as a basis of assessment of sterilisation of the investigational devices.

If the investigational devices are sterilised, you should include:

• the method of sterilisation

• details of the sterilisation facility, name, location, process

• details of the records for product release (for example, indicator testing, dosimetric release, parametric release) and this should include the results and outcomes

• details of any standards applied to the any of the sterilisation processes

You should also provide a sterilisation validation report for each component including:

• proof of sterilisation validation protocols and processes to demonstrate that the sterilisation process can be delivered effectively and reproducibly to the specified devices in the sterilisation load (for example, validated results, certificates, standards, risk assessments) and justification for the choice of sterilisation process

• details of appropriate methods for bioburden determinations (for example, type, frequency, results and outcome)

• details of microbiological environmental precautions undertaken on the devices during manufacture or sterilisation (for example, type of controls, frequency of monitoring, results and outcome)

If devices are to be sterilised at the point of use, where appropriate, you should include

• a copy of the instructions for decontamination (for example, cleaning, disinfection and or sterilisation) including details of any special precautions for handling

• appropriate validation data to demonstrate that the processes can be delivered effectively and reproducibly to the specified devices must be provided

Where devices are sterilised at the point of use, and moist heat (steam) is chosen as the method of sterilisation, particular attention should be taken with regards to the ‘standard sterilisation parameters’ applicable within the country where the devices are to be processed and sterilised.

The appropriate sterilisation qualification and validation reports should take account of the standard requirements. This includes:

• specification of manufacturing environment used

• details of any cleaning process prior to sterilisation

• method of sterilisation

• parameters of the sterilisation process

• sites of sterilisation (if different from manufacturing sites)

• packaging materials used

• summary of sterilisation validation data

• details of routine monitoring of the sterilisation process

Software information

The clinical investigation application form on IRAS has been designed to help manufacturers set out the information required by the MHRA for the basis of assessment of software. This is relevant for all medical devices that include a software component, either stand-alone software, or software incorporated into a medical device. You should ensure all documents referenced in the answers given to the software questions in the Clinical Investigations Application form are provided within your submission.

You should demonstrate that the software has been developed in accordance with its safety classification. As a minimum, you should include:

• software development plan

• risk management plan and report – specifically including the software hazard analysis

• software configuration management plan

• software system requirements specifications

• software system verification plan and report

• documented software problem resolution process

• evidence of review of completeness for software release

For stand-alone software, you should ensure the whole system is considered and hazards caused by the platform or hardware the software is run on are addressed.

Biological safety assessment of patient contacting materials

A biological safety assessment is required for all investigational devices that are patient contacting. You should include:

• a detailed description of how biocompatibility and biological safety have been addressed

• a risk assessment covering the rationale for the decisions adopted explaining how hazards were identified and characterised and how the risks arising from the identified hazards were estimated and justified in relation to anticipated benefits

• a description of how the biological safety of the device has been evaluated, including the identity of the people responsible for the risk assessment, a summary of the data examined and the basis for the judgement that the materials are suitable for the proposed use

• information sufficient to characterise fully the identity and chemical composition of all materials coming into patient contact, including name and address of manufacturer, trade name and code, quantitative formulations, results of chemical analyses, assessments of the effects of sterilisation or other processes, or other data as appropriate

• haemocompatibility risk assessment (all endpoints should be considered including haemolysis, thrombosis, coagulation, platelet activation and the working of the complement system)

Particular attention should be paid throughout to biological safety issues, especially for devices containing new materials that will come into contact with patients or where established materials are used in a situation involving a greater degree of patient contact. For example, where particularly hazardous materials may be present in the final device, the risk assessment should indicate why solutions avoiding the hazard have not been adopted.

You can find out more in our guidance on biological safety assessments

Information on animal tissues

For medical devices incorporating tissues of animal origin, you should include a clear, justified statement on:

• the decision to use animal tissues or derivatives

• the expected clinical benefit

• the evaluation of similar materials of animal origin and other synthetic alternatives that achieve the desired product characteristics and intended purpose

You should also include an overview and assessment of the key elements adopted in the risk management to minimise the risk of infection including the:

• availability of suitable alternatives

• selection procedures and systems for sourcing the tissue or derivative

• details of the production processes and animals used

• source country including the assessment of geographical risk

• nature of the starting materials

• systems for inactivation or removal of transmissible agents and validation of these

• any other risk management measures that have been applied to reduce the risk of infection

• quantity of animal starting tissues or derivatives required to produce one unit of medical device

• tissues or derivatives of animal origin coming into contact with the patients and users, and the route of application

• practices of post-market surveillance system including gathering and assessment of new information of the potential risks arising from the use of the end product

Information on any medicine or human blood derivative incorporated into the device

The MHRA require additional information about medicinal substance or human blood derivatives. This includes:

• the intended purpose of the inclusion of the medicinal substance in the context of the device and the risk analysis

• the source, marketing authorisation (where applicable) and the quantity/ dosage of the medicinal substance, incorporated into the device

• the method of manufacture (for example, solvents or reagents used in processing, residuals)

• the qualitative and quantitative tests carried out on the medicinal substance in the device

• stability data in relation to the expected shelf-life/ lifetime of the device. Patient information regarding storage of the device should be included

• clinical documentation (clinical data demonstrating the usefulness of the medicinal substance)

We require additional information about the medicinal substance only. Control of the medicinal substance information should include the medicinal substance specifications, such as a summary of the European Drug Master File, EDQM Certificate of Suitability, reference to European Pharmacopoeia or national monograph of a European Member State.

Manufacturers may wish to cross-reference a granted Clinical Trial Authorisation (CTA).

You can find out more in the rules governing Medical Products in the European Community’ volume III, Addendum II.

You should also include:

• a toxicological profile (summary of results of toxicity testing and biological compatibility), including the effect on reproductivity, embryo, foetal and perinatal toxicity, and the mutagenic and carcinogenic potential of the medicinal substance

• pharmacodynamics of the medicinal substance in relation to the device

• pharmacokinetic characteristics (local and systemic exposure patterns, duration and maximum exposure and the maximum plasma concentration peak taking into account individual variability) - active substances should address the release of the substance from the device, its subsequent distribution and elimination

• local tolerance, particularly where the route of exposure is different to the conventional application (for example, results of EN/ISO 10993 testing, or a review of scientific literature)

We require additional information about the human blood derivative only. Control of the human blood derivative information should include:

• control of plasma source (for example, a summary of the European Plasma Master File)

• pharmacodynamics of the human blood derivative in relation to the device

• production of the blood derivative

Manufacturers may wish to cross-reference a granted CTA or marketing authorisation for a medicinal product.

Active devices

For active medical devices information should be provided in the device details or the summary of all bench testing and pre-clinical testing conducted.

You should provide documentary evidence supporting compliance with any of the standards referenced, which may include certification by an independent body, or test house. Alternatively, self-certification is acceptable, providing this is supported with evidence of design input and subsequent in-house verification

For applicants choosing self-certification against EN 60601-1 (which includes protection against electric shock hazards, mechanical hazards, fault conditions, constructional requirements and so on) a checklist for that standard, or equivalent, should be provided. This should be completed and signed by a competent engineer. Where clauses are considered not applicable, a justification should be given. Where measurements of leakage currents are made, the values should be recorded.

When the medical device is to be used with other devices as part of a system (for example, connection to laptop computers), an additional EN 60601-1-1 checklist or equivalent covering the whole system under investigation should also be provided.

You should also provide details and diagrams of:

• how the battery is sited within the device

• the earthing to ensure patient-user safety

• earth leakage current

• whether the devices incorporate electrical and thermal fuses

• battery consumption indicator

• audible and visual low battery alert

• audible and visual battery error alert

• other audible and visual error alerts

Specialist technologies

Specialist technologies include infra-red, laser, microwave, MRI, RF ultrasound, ultraviolet, X-ray and similar.

The device details or the summary of all bench testing and pre-clinical testing conducted should include details of how this technology has been incorporated in the design and what steps have been taken to assure the safe application in the device.

Information pertaining to output power, justification of safety limits used and reference to appropriate standards should be included (for example, the relevant part 2 of the EN 60601 series).

Active Implants

For active implantable medical devices information should be provided in the device details or the summary of all bench testing and pre-clinical testing conducted. You should provide:

• a summary of the Failure Mode, Effects [and Criticality] Analysis (FMEA/FMECA).

• the results of animal studies

• performance statistics and adverse incident data of earlier model, when device is the next generation of an earlier design

If you have questions before submitting your proposal

Before you make a notification, we are happy to answer any questions that you may have about the UK regulatory process for clinical investigations.

We are not able to perform a full assessment of your proposed clinical investigation until you submit it. We recommend contacting  us if you have any concerns before submitting a notification. In some cases, where specific issues cannot be addressed in writing, we may arrange a pre-submission meeting or conference call.

You can email us at info@mhra.gov.uk, make sure you add ‘clinical investigations enquiry to the subject line.