How to get a CE Mark from the MHRA
How to notify the Medicines and Healthcare products Regulatory Agency (MHRA) of an intention to carry out a clinical investigation for CE marking
Companies often have to carry out clinical investigations as part of the process to obtain CE marking for medical devices. This must be done at least 60 days before the investigation starts.
All documents for the proposed clinical investigation must be prepared in advance of notifying the MHRA. The documents which are required include PCA1 and PCA2 on the integrated research application system (IRAS).
Eight copies of the submission forms and additional documents must be included. Additional documents are:
- 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
- sterilisation 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
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