Sir, – There has been confusion within the media on the terminology of “unauthorised”, “non-CE-marked” or “uncertified” medical devices. A CE marking indicates that a commercial product meets health and safety requirements.
What has not been made clear is that there are two important scenarios in which use of a non-CE-marked medical device is permitted, with the informed consent of the patient.
The first – termed an “investigational device” – applies to research studies which take place under appropriate ethical and regulatory approvals.
The second type of device is termed a “custom-made” or “in-house manufactured” device.
A decision to design and make an in-house device can be made when a medical professional or clinical team deems that there is no suitable medical device available on the commercial market (ie CE marked) to treat a particular patient. In-house medical devices are exempted from most of the provisions of the medical devices regulations (MDR), which is the set of rules currently in place throughout the EU for medical devices.
In-house devices can be particularly important for treating children with rare conditions, due to the limited availability and market for paediatric medical devices. In-house medical devices – under appropriate safety controls – have been, and should continue to be, a crucial tool used by clinical teams to treat patients when no suitable commercial device is available. – Yours, etc,
Prof NIAMH NOWLAN,
Professor of Biomedical Engineering,
University College Dublin,