MDCG issues version 2 of the Borderline and Classification Manual

The Medical Device Coordination Group (MDCG) – a working group of the European Commission – has issued a second version of its Manual on Borderline and Classification for Medical Devices and in-vitro diagnostic devices under the MDR and IVDR. 

We previously reported on Version 1 of the Manual in our October 2022 newsletter, noting that the document was only partly-populated, with many sections being left completely blank. In the four months between the publications, the MDCG has considered several new borderline issues which are included in the updated document.

There are three new additions to the Manual. This includes two new borderline qualification decisions, and one classification decision. 

New Borderline Qualification Decisions

The borderline qualification section of the Manual sets out a series of practical cases illustrating the approach taken for goods which meet the definition of both a medical device and another regulated product type. In particular, the manual addresses the borderline between medical devices and:

• medicinal products
• biocides
• substances of human origin
• cosmetic products
• food
• personal protective equipment
• general consumer products. 

The two new borderline decisions found in Version 2 of the manual do not fall under any of the above categories. Instead, they are grouped under the general ‘other medical device borderlines’ section.

Medical Calculators

The first new borderline decision concerns medical calculators. Medical calculators are intended generally to facilitate routine medical calculations at the point of care, for multiple clinical disciplines by means of an app or webpage. These calculations are often relatively simple, and in many cases could be performed with a basic electronic calculator or even on paper. They are operated by a healthcare professional, who enters patient-specific variables, after which the app calculates outcomes (such as risk scores, threshold values, severity indexes or other prognostic outcomes) depending on the specific calculation required. These outcomes are then used by the healthcare professional at the point of care to make decisions concerning diagnosis or treatment of a patient. 

Version 2 of the Manual provides the following example of a medical calculator:

‘A medical calculation of the stroke risk of a patient with atrial fibrillation, using the CHA₂DS₂-VASc Score to determine if patients need antithrombotic therapy.’

The medical purpose for this calculator is, as mentioned above, usually diagnosis or treatment. Noting that the calculation in this case goes beyond simple search functions and that the results are specific to individual patients (as opposed to generic population groups), the MDCG concluded that this product would be regulated as a medical device under the MDR.

The qualification of medical calculators as medical devices in the EU follows a similar logic to the US and Australia. In the US, software that performs simple calculations routinely used in clinical practice qualifies as a medical device. However, due to the relatively low-risk nature of such products, the FDA exercises enforcement discretion over them. 

In Australia, the TGA makes a distinction between calculators that do qualify as medical devices and those that do not. Where the calculator meets all of the following criteria, it will not qualify as a medical device: 

• Uses relevant published clinical standards or authoritative sources to make its calculations/outputs,
• Allows its calculations/outputs to be validated by the user, and 
• Does not control the administration of a calculated dosage (an example of a product that does do this would be an automated insulin bolus calculator for insulin delivery pumps).

However, in all other cases, clinical calculators are to be regulated as medical devices in Australia. 

Needle Counters

The second borderline case added to Version 2 of the Manual concerns needle counters. These are intended to allow for counting in order to reconcile the number of suture needles and scalpels present before a procedure with the number present after. They are designed to facilitate the temporary storage of these instruments, with some models containing a magnetic base and numbered spaces, whilst others contain a high-density foam to hold the needles securely in place. 

Of the products currently available on the European market, the MDCG notes that the following indications are generally provided by manufacturers:

• To guarantee the safe elimination of scalpel blades and suture needles used in operating rooms; 
• To permit counting of scalpel blades and needles used in the operating room;

The MDCG also notes that some manufacturers have claimed that the intended use of their needle counters is the prevention of injury to patients should any needles remain on the body after suturing. Nevertheless, the MDCG rejects the idea that such claims would lead to the qualification of a needle suture as a medical device. The reasoning behind its decision is that the product does not meet the legal definition of a medical device as it doesn’t have a specific medical purpose.

New Classification Decisions

Medical Calculators

Having qualified medical calculators as medical devices in the borderline qualification section of the Manual, the MDCG then goes on to discuss the issues that might arise when classifying such a product. The applicable classification rule here is Rule 11, first paragraph of the EU MDR, which states:

“Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: 

• Death or an irreversible deterioration of a person’s state of health, in which case it is Class III
• A serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.”

The classification of medical calculators will therefore depend on the significance of the information provided by the device to support the healthcare professional’s decision in the context of the patient’s specific condition. However, such products will be at least Class IIa, meaning the manufacturer must see their product go through the relevant conformity assessment procedure by an EU Notified Body. 

How we can Help

Regtik, our healthcare regulatory explorer tool, can help you navigate the legal maze by walking your product through a series of simple questions designed to determine whether it is a medical device and, if so, what market rules apply. It is able to provide results for various jurisdictions (the US, EU, UK and Australia) in one single assessment and can be used multiple times on different versions of your product.

If you are interested in learning more about Regtik or would like to request a demo, please contact any member of our team or register your interest below.