The UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued a guidance on how to inform the agency of the intention to carry out a clinical investigation for CE marking.
Manufacturers are required to notify MHRA at least 60 days before starting their Clinical Investigations. The updated guidance document provides more detailed guidance on how to do this; by notifying the agency of their intention to submit a clinical investigation, via email, by providing the following information:
- Basic details about the investigational device
- Intended population
- Type of study
- Estimated application date.
A link to the full list of documentation required for the notification, links for obtaining the PCA1 and PCA2 forms and a guidance on the preparation of the notification application are provided in the MHRA’s guidance note.
Once the manufacturers’ documentation is received by MHRA and has been validated, the applicants will receive a confirmation within 5 working days to confirm that the 60-day assessment has started or if there are any issues.
The guidance also provides information about the manufacturers’ obligations once a letter of no objection is received. The guidance says that the applicant must notify MHRA of all proposed amendments to the investigation and must wait until another letter of no objection is received before such changes can be implemented.
- The MHRA must be informed about any changes made to:
- The device under investigation
- Study documentation, including the clinical investigation plan
- Investigators or investigating institutions
- Changes requested by an ethics committee.
To see the guidance in full, please click here.