Incidents defined under the new Medical Device Regulation
A large number of new requirements in regard to the safety of medical devices were brought into effect with the recent EU Regulation 2017/745. One important such practice was the requirement for an established process to be set in place for reacting to and reporting ‘incidents’ involving medical devices and how manufacturers or distributors in Europe should put them in place effectively. To give a greater level of clarity on the issue, we are going to examine the definition of ‘incident’ as outlined in MDR 2017/745 as well as some of the points most important for manufacturers operating in the European market to know.
Under the new regulation, the word ‘incident’ has a couple of meanings and categories, some of which correspond to other new practices and guidelines laid out by 2017/745/EC. They are:
- Incident: An incident is simply defined by the regulation as a ‘malfunction or deterioration’ in the function or aesthetic of a product as well as unclear, unprovided, or miscommunicated information regarding the product, its uses, and its possible side effects.
- Serious Incident: A serious incident, in the context of 2017/745/EC, denotes any direct or relevant indirect link between the use of a medical device and the death of a patient or user, a ‘serious public health threat’, or the temporary/permanent loss or deterioration of a patient or user’s state of health or wellbeing.
- Serious Public Health Threat: The regulation defines a ‘serious public health threat’ as an event or occurrence involving a medical device which may result in the death of a person or a deterioration in the state of their health. This can include serious illnesses, incidents that require immediate remedial action, or situations that directly affect the mortality of those in contact with the device outside of what is expected in its given scenario of use.
Another important caveat introduced under Regulation 2017/745 is than an ‘incident’ does not necessarily need to be an actual event. The term can also apply to the potential for an incident or negative outcome.
2017/745/EC also outlines, in the scenario that an incident would occur, that manufacturers and distributors establish a risk management and reporting system to minimize the potential for any further incidents taking place in the same manner. It also encourages European member states to take steps to inform healthcare professionals and those using devices affected by the regulation about the importance of reporting device-related incidents, as well as enabling them with whatever tools they need to do so. In addition, it also dictates that manufacturers engage in a Unique Device Identification system (UDI system) in order to create greater product transparency throughout Europe and increase the effectivity of post-market surveillance.
As always, the best defence against the negative impact of a device related incident is to be aware of the potential risks and take preventative measures. Failing that, full knowledge, on part of the manufacturer or distributor, is essential in providing the market, the consumer, and any relevant Competent Authorities with any risk related information they may need to make informed decisions regarding the device.
To find out more about how the new medical device regulation may affect your products or practices, for advice from or team of European legislative and regulatory experts, or to learn more about out Authorized Representative or CE Marking services, contact us today.