Updates to the Manual on Borderline and Classification

By Annette van Raamsdonk 

The “Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v4” has recently been revised and includes several new case examples that may be relevant to your product portfolio. Manufacturers of dental products, items used in operating theatres, or creams containing menthol, as well as companies that incorporate these products into broader systems or services, may find the revised manual especially relevant to their operations.

What is new?

We’ve paraphrased significant changes found in the new manual. If you manufacture any of the devices listed below, or similar devices that use the same substances or techniques, we recommend reviewing the complete revised manual.

1.1.2.5 Classification of red blood cell additive solutions containing adenine

Several systems on the market are intended to process and store red blood cells (RBCs). When these devices incorporate adenine into additive solutions, a substance considered medicinal when used separately, and the substance has an ancillary action to the device, Rule 14 of Annex VIII to the Regulation (EU) 2017/745 applies. As a result, the device should be classified as Class III.

1.1.2.6 Classification of dual action cream with menthol and capsaicin

A topical cream formulated with menthol and capsaicin is marketed for its dual cooling and warming effects, intended to relieve muscle and joint discomfort. Both menthol and capsaicin are known to interact with specific receptors in the skin and are recognized as having pharmacological actions, particularly in the context of pain relief.

Because the product’s principal intended action is achieved through pharmacological means, specifically via receptor interaction, it does not meet the definition of a medical device. Unless the manufacturer can provide clear evidence that the product’s main effect is not pharmacological, immunological or metabolic, it is considered a medicinal product. As a result, classification as a medical device is not applicable.

1.1.2.7 Lactose tablets for vaginal use 

In this application, lactose tablets serve as a nutrient source for increasing indigenous lactic acid bacteria populations, which help reduce problematic flora. If there is no evidence showing that the product’s main effect on the human body is achieved through non-pharmacological, non-immunological or non-metabolic means, it should not be considered a medical device.

1.1.5.1 Qualification of microabrasion dental stain removers 

Some manufacturers have marketed dental stain removers, particularly those that use microabrasion techniques for whitening, as medical devices. However, improving the appearance of teeth by removing stains, regardless of the method used or the origin of the discoloration, does not represent a medical purpose.

Unless a manufacturer can provide scientific evidence that the product contributes to the prevention, treatment or relief of a disease, it does not meet the criteria for classification as a medical device. 

1.1.7.3 Qualification of medical examination table covers 

Covers designed for medical examination tables are intended to serve a health-related function, specifically, helping to prevent the spread of disease. Because of this intended use, they meet the criteria for classification as medical devices under Article 2(1) of Regulation (EU) 2017/745. This determination is not based on the specific materials or composition used in the product.

1.1.9.6 Mobile sterile air system 

Mobile sterile air systems are designed to maintain a sterile zone where minor medical procedures can be performed. While they contribute to creating a controlled environment, these systems do not directly interact with the human body or serve a specific medical purpose.

Because their role is limited to environmental management, rather than diagnosis, prevention or treatment, they do not meet the definition of a medical device under Article 2(1) of the Medical Device Regulation (MDR) and therefore should not be classified as such.

Stay informed and support compliance by checking out the latest updates in this manual.