Manual on Borderline and Classification in the Regulatory Framework for Medical Devices (MDR 2017/745)

By Guillaume Promé
Jan. 3, 2023 Regulation (EU) 2017/745

[article originally published on 08 september 2022]

A classification manual for bordelines devices is available (actually in version 2) on the European Commission website, its name is self-explanatory: it sets the medical device status of certain borderline devices according to the regulatory definition of medical device, and it classifies some MDs according to the rules of Annex XVIII of Regulation (EU) 2017/745.

This document will be regularly updated, as will this summary article.

Medical Device or Medicinal Product?

Nasal spray with antibodies for COVID-19

The main action is pharmaceutical, it is not a medical device.

Graphite crucible

According to the directive 2001/83/EC (medicinal products), these products are radionuclide kits, the medicinal products directive applies, they are not medical devices.

Product for professional removal of dental biofilm

The main action is pharmaceutical, it is not a medical device.

Medical Device or Biocide?

Substance for textile treatment to confer antifungal, antimicrobial and/or antiviral properties

Not considered a medical device because “it does not act on individual patients”.

The notion of individual patient cannot be found in the regulation. It can be qualified as a non-medical device because of the non-therapeutic and/or diagnostic claims.

Medical Device or Personal Protective Equipment?

Rescue bag for patient transport

The claim includes the word patient, so it is a medical device, class I (rule 1).

Plexiglas box for caregiver protection

The claim is to protect a non-patient, it is not a medical device.

Medical Device or Other?

Application designed to prevent sexually transmitted infections by allowing the exchange of information between different sexual partners.

Not considered a medical device by the guide.

Product description:

Permits the recording of biological analysis results, like STI results, in order to share this information with other potential sexual partners, within a network. During an encounter, these results are shared by scanning a potential sexual partner’s QR-code; the user then becomes part of each other’s networks. Where the functionality has previously been set up by the user, in case of positive tests for an STI the application sends automatic anonymised notifications to all those in their sexual network (two degrees of contact). In this case, the application lets the user know what to do and helps him/her find the right services. For example, it encourages users to avoid unprotected sex and advises them on recommended testing practices based on their most recent data, limiting the spread of an STI within a sexual network and fostering earlier testing and treatment. According to the manufacturer, this application also allows the evaluation, through “the risk calculator” function, of the risk of infection with an STI based on sexual habits, the number of connections, and also levels of infection in the network of sexual partners.

Analysis according to the guide:

The application does not prevent sexually transmitted diseases, but rather facilitates the exchange of information and communication between different users. The application also contains a particular functionality that assesses the user’s risk of contracting a STI. The risk calculation is based on the behaviour of this person and their contacts tree. In this case, the prevention does not rely on specific characteristics of the individual user (physiological parameters, etc…) but mainly on their sexual habits and behaviour towards their partners, within a sexual network.

Here, the purpose (to prevent a disease) is obscured the technical means (transmission of information) and the failure to take into account “physiological parameters, etc…” of the user.

Medical calculator

Software implementing formulas from the literature (e.g. risk score calculation), even simple ones. These are medical devices, class IIa, IIb or III according to rule 11.

Needle counter

Used to count needles and scalpels, to avoid the risk of cutting, to check quantities (before or after use) and to facilitate disposal. They are not medical devices.

Classification of Medical Devices

Dermal filler implantable

These are implantable DMs, rules 7 and 8 apply, with the class likely ranging from IIa to IIb depending on the duration of use.

Argon coagulation units

Active therapeutic devices intended to deliver or transfer energy in a potentially hazardous manner, Class IIb per Rule 9, first paragraph.

Ethylene oxide gas cartridges (sterilizer)

Product intended to sterilize a medical device, Rule 16, Class IIa.

Source : European Commission