Kiri

Dear Health Board (Medical Devices Department),

I am writing in regard to queries about performance study notifications as described in IVDR.

From my understanding, there are two occasions when a notification to a Competent Authority is required:

• Post-market performance follow-up (PMPF) study involving a CE marked device being used within its intended use, but for which the study involves additional invasive or burdensome procedures

• Performance studies involving Companion Diagnostics (CDx) using only left-over samples

For context, Almac Diagnostic Services design, develop and manufacture in vitro diagnostic (IVD) devices which are utilised only within Almac’s clinical laboratories in Northern Ireland (NI, UK) and North Carolina (USA). Clinical samples are sent from EU member states to Almac for analysis within the Almac clinical laboratories. The results generated contribute to the clinical performance data for the IVD (for CE marked devices and/or CDx).

If testing is performed in the Almac NI laboratory, a notification will be sent to the UK Competent Authority, the MHRA, to ensure IVDR requirements are met as an EU testing site (as described in the NI Protocol/Windsor agreement). However, we would like to understand additional notification requirements for testing outside the EU (in the USA Almac laboratory) and if additional notifications for testing in NI is required.

Question (1): For PMPF studies performed in the Almac USA laboratory, and samples have been collected from Estonian subjects, does Almac need to send a notification to Health Board (Medical Devices Department)?

Question (2): For PMPF studies performed in the Almac NI laboratory, and samples have been collected from Estonian subjects, does Almac need to send a notification to Health Board (Medical Devices Department) in addition to the MHRA?

Question (3): For CDx performance studies, if the left over samples have been collected from Estonian subjects as part of a previous clinical trial which had gained regulatory and ethical approval, and the informed consent provided allowed future studies to be performed on the clinical sample, for testing within the Almac USA laboratory, does Almac need to send a notification to Health Board (Medical Devices Department) or are the previous approvals enough?

Question (4): For CDx performance studies, if the left over samples have been collected from Estonian subjects as part of a previous clinical trial which had gained regulatory and ethical approval, and the informed consent provided allowed future studies to be performed on the clinical sample, for testing within the Almac NI laboratory does Almac need to send a notification to Health Board (Medical Devices Department) or is the MHRA notification and previous approvals enough?

Kind Regards,

Ruth Scott