The Medical Device Directive is now a full-blown Medical Device Regulation. What does this change mean for displays you might have in service in Europe, and ones you will need to buy in the future?
MDR, the Medical Device Regulation in full, is a new European legislation that regulates which products are allowed to be sold in Europe for medical use.
The MDR was drawn up following a scandal about unsafe breast implants in 2005. It aims to guarantee the safety of patients that require treatment using medical devices within the European Union.
Depending on the potential patient risks associated with medical devices, they must be categorized in one of four classes (I, IIa, IIb, or III). The higher the risk class, the stricter the requirements laid out in the MDR.
A notified body is an organization authorized to officially assess the conformity of products before they are placed on the market.
It is up to the manufacturing companies to assign their products to the correct class. When they have achieved certification, they are officially allowed to sell the product in Europe.
However – and this is where it gets tricky – there is no “police” or organization that will double-check whether the device was registered in the correct category.
In other words, there is no instance that will correct or stop you when you register a high-risk device as a Class I product through the self-certification process.
As it now stands, the law will only see a low-risk Class I product. That raises the question: where does responsibility lie when the device causes harm or provides incorrect information about a patient? The classes, after all, are meant to guide medical organizations when they buy new products without having to worry about their risks.
So how can a manufacturer know to which class their products need to belong? Well, the MDR lists a series of rules to help them correctly assign the right class to their products.
Rule 10 covers a whole range of equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic radiology (source: MDCG 2021-24 guidance on classification).
Our Regulatory team worked with TÜV SÜD Product Service GmbH, a well-known German notified body. For diagnostic procedures, our assessment based on this rule is that diagnostic displays should be considered as Class IIa risk products. From this, it follows that any software that supports and enhances diagnostic readings needs to be registered in the same class as the displays that they support. For Barco, this would seem self-evident.
In practical terms, this means that Barco assumes its responsibility as the manufacturer in case of issues arising from the manufacture of the displays .
All Barco medical products have been certified and comply with the new MDR.
Our radiology displays, QAWeb Enterprise and Intuitive Workflow Tools are already MDR-certified as Class IIa, in line with the MDR’s rule 10. Their product information has been reviewed and cleared by independent medical and technical experts and is audited yearly. In other words, we ensure diagnostic confidence and peace of mind for our users.
Our surgical and clinical review displays are Class I medical devices, as they pose lesser risk to patients.
