The medical devices and In Vitro Diagnostic devices (IVDs) under the European Union Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746 are categorized into four (04) classes and twenty-two (22) rules (MDR)/ seven (07) rules (IVDR). Compared to the previous scope of the product in the Directives, the current regulation has expanded its scope. For instance, the EU MDR now covers contact lenses as well.  

The EU MDR (Article 02) defines medical devices as a means of any instrument, apparatus, appliance, software, reagent, implant, material, or any other article which is intended to be used for:

  • Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
  • The investigation, replacement, or modification of the anatomy or a physiological or pathological process or state
  • Providing information using in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations

The EU IVDR (Article 02) covers a medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software, or system, used alone or in combination, where the device is used In Vitro for examination of specimens to provide information in the aspect of the following:

  • Physiological or pathological process or state
  • Congenital physical or mental impairments
  • Predisposition to a medical condition or disease
  • Determining the safety and compatibility with potential recipients
  • Predicting treatment response or reaction
  • Defining or monitoring therapeutic measures

Some products do not fall under this scope, as well as under the Medicinal Products Directive (MPD) 2001/83/EC.

While for combination products, the Regulatory rules applicable are made clear based on the principal actions, there are a few products whose classifications are ambiguous. These products are defined as borderline products, and it is unclear from the outset if the concerned product falls under the EU MDR, EU IVDR, or MPD. Article 04 of EU MDR and Article 03 of EU IVDR cover some aspects of borderline products between medical devices and other types of products.

Understanding the borderline products seems to be confusing and creates a potential dilemma for the manufacturers to place their medical devices in the EU geography. Hence, the Borderline and Classification Working Group (BCWG) recently released a manual on borderline products. The 18-page long document provides different case scenarios among the borderline products. For example, the borderline between medical devices and IVD, medical devices and cosmetics, medical devices and food, medical device and personal protective equipment, and IVD and general laboratory equipment. The document explains some of these case scenarios with a reference product. One of the sections covers the product background giving in detail the framework of the product and its intended use. The next section provides insight into the outcome, based on the principal action of the product determining if it qualifies as medical devices/ its accessory or not.

Let’s take an example of a rescue bag for patient transport which is considered a borderline product between medical devices and personal protective equipment. The intended use of the rescue bag is to protect patients mechanically and thermally while transporting. The rescue bag consists of an additional padding area to support the head, sewed side straps for stabilizing patients, and attached safety equipment for different operations.

Herein, the principal mode of action considered is stability and protection of the patient during transportation to prevent worsening the state of health of the patient. Now, let’s look at the intended use of the product; it corresponds to the “diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability” of article 02 mentioned in the EU MDR. Therefore, it qualifies as a medical device product.    

Further, let us take another example of Fractional Exhaled Nitric Oxide (FeNO) measuring devices. This measuring device is constituted of different parts, where the instruments and breathing handle are considered under the EU IVDR, but the disposable filter is a CE-marked product under EU MDR. Here, the principal intended purpose of the product is to be used for examining the specimen derived from the human body. This scope gets covered under Article 2(1) of EU IVDR. Therefore, the FeNO measuring devices will be considered IVDs and regulated under the EU IVDR 2017/746.

To determine the classification of such products, the Helsinki procedure is adopted wherein, upon inquiry/issue occurring, the concerned Competent Authority (CA) consults with other CA and takes opinions for the same. Based on this opinion, a summary judgment is drafted, and voting is taken place. The majority views (only 75% and above) are considered, and a conclusion is derived.

We understand that the first step is very crucial and can sometimes be challenging in the Regulatory lifecycle! Hence, Freyr is here to help you with any queries related to your medical devices and their classification under EU MDR and EU IVDR.

Contact Freyr today!


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