Northern Ireland is aligned with the European Union (EU) device regulations as per the Northern Ireland Protocol following the end of the Brexit transition period. The application of the EU Medical Device Regulation (MDR) has implications for clinical investigations involving a site in Norther Ireland which has led the Medicines and Healthcare Products Regulatory Agency (MHRA) to update its guidance on the matter.
Applications for clinical investigations of a device involving a site in Northern Ireland must be submitted to the MHRA. Any proposed sites in Great Britain (GB) must also be detailed in such an application. Documents will be validated and the MHRA will inform the applicant of the validity/invalidity of their application within 10 calendar days. Applicants will have a 10 calendar day period to respond to any issues. Day 1 of the MHRA assessment is taken as the date from when the agency confirms that they have received a valid application, a final decision will be provided by the MHRA within 45 or 60 calendar days. However, if additional information is requested, the clock will be stopped for a maximum of 7 calendar days per request, up to a maximum of 3 requests.
Serious adverse events (SAE) during a clinical investigation involving a device in Northern Ireland should be recorded using the MDCG 2020-10/2 SAE reporting table and sent to the MHRA via firstname.lastname@example.org. The events that require reporting are:
- Any SAE that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible
- Any device deficiencies that might have led to an SAE if appropriate action had not bee taken, intervention had not occurred, or circumstances had been less fortunate
- Any new findings found in relation to the two above points.
Once an investigation within Northern Ireland has been authorised, the MHRA must be informed of any modifications prior to their implementation. However, only substantial modifications require MHRA authorisation, and this will require another letter of authorisation to be issued. If a non-substantial modification is submitted and the MHRA decide it is better categorised as a substantial modification, the agency will inform the sponsor and the proposed modification must not be implemented until the MHRA authorisation letter is received.
The MHRA must also be notified of any post market clinical studies conducted in Norther Ireland involving CE marked devices. The notification must be received at least 30 days prior to the commencement of the study, applications are submitted using the Integrate Research Application System (IRAS).
The updated section of the guidance on Northern Ireland can be found here.