Conducting a Clinical investigation (CI) in the UK
If you are planning on conducting a clinical investigation with a Medical Device (MD), or in-vitro Medical Device (IVD) in the UK, this blog sets out some of the requirements before you begin!
Clinical investigations with Medical Devices and IVD performance studies in Great Britain continue to follow the UK MDR 2002.
Clinical Investigations in Northern Ireland are now required to follow the EU MDR and IVDR and the associated timelines.
Which CIs need MHRA approval?
Does the CI involve human subjects?
Is the device being used for a medical purpose?
Is the device CE or UKCA marked?
No (or if yes, its being researched for a new purpose)
Is the CI being conducted under the Healthcare institute exemption?
REQUIRES MHRA AUTHORISATION
Using the Healthcare institution exemption – if any of the following statements apply you must notify the MHRA and receive authorisation:
- conducting the CI in more than one institution
- the device’s manufacturer is outside of the healthcare institute and is involved either by intentionally supplying the device the CI or is funding the CI.
- There is intention to place the device on the market
IVD Performance studies: For GB these are required to be registered with MHRA. Applicants/UKRP must complete a Declaration for Performance Evaluation according to UK MDR 2002 Regulation 43 Statement (Annex VIII of Directive 98/79/EC (IVDD)) or Part A of Annex XIII of EU Regulation 2017/746 (IVDR) is required for all performance evaluation studies.
Process & timelines
Making the application – for ALL applications this is done through the Integrated Research Application System (IRAS) Link here
What you need to submit:
- • 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 / 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)
MHRA Compliance Validation & Review:
Applications for Great Britain only – The 60 day assessment period will commence once a valid notification is received by the MHRA.
Validation should be confirmed within 5 working days from submission.
Day 1 is considered to be the first working day following validation.
MHRA will then commence a 60 day review period.
Applications involving Northern Ireland (with or without a site in Great Britain) – Following submission MHRA will confirm within 10 calendar days if the application is valid. Any issues with the submission will be communicated in writing. An assessment will only commence once it is considered valid.
Day 1 of the MHRA assessment is taken as being the date that MHRA confirm the application is valid application.
The assessment timeline under the EU regulations is 45 calendar days, if MHRA consult experts for the assessment then this extends to 65 calendar days – you will be informed if this is the case. The assessment period will be suspended in the event that MHRA request additional information for a maximum of 7 calendar days for each request, up to a maximum of 3 requests. Any further requests will not result in a clock stop.
Common reasons for an objection
– Incomplete data at validation
– Insufficient evidence provided to demonstrate: o the appropriate biological safety, o Sterlisation o clinical or technical effectiveness of the device o Insufficient software testing
– Poor study design
– predominantly statistical issues.
Is ethics approval required?
All clinical investigations of medical devices falling within the scope of the UK MDR 2002, Part II for medical devices, or Chapter VI of EU MDR, require a relevant ethics committee opinion. This opinion should be sought either before or in parallel with the notification to the MHRA. If either the ethics committee or the MHRA provide an objection the research cannot commence.
Eclevar MEDTECH can support you with your application and the drafting of the documents required. If you have any further questions, please reach out to the team at firstname.lastname@example.org to learn more.
ECLEVAR MEDTECH – SAS au capital de 10 000€ – NAF 7490B N° SIRET 89000541600015 – N°de TVA Intracommunautaire FR80890005416 – RCS NANTERRE 890 005 416 – SIREN 890 005 416 – SAS – Tour Europlaza, 20 avenue André PROTHIN, 92400 Courbevoie – 01 80 88 73 40- www.eclevarmedtech.com Is ethics approval required? All clinical investigations of medical devices falling within the scope of the UK MDR 2002, Part II for medical devices, or Chapter VI of EU MDR, require a relevant ethics committee opinion. This opinion should be sought either before or in parallel with the notification to the MHRA. If either the ethics committee or the MHRA provide an objection the research cannot commence. Eclevar MEDTECH can support you with your application and the drafting of the documents required. If you have any further questions, please reach out to the team at email@example.com to learn more.