EMERGO SUMMARY OF KEY POINTS:

• Second update IN 2018 of the Manual on Borderline and Classification.
• Five new cases added, providing useful illustrations of how the definition of a medical device and the classification rules should be understood.
• For the MDR there could be some significant differences.

On October 30, 2018 the European Commission published the most recent version of the Borderline & Classification Manual. This document provides guidance on establishing the status of medical devices and IVDs, as well as their risk classifications. The current version, version 1.20 replaces version 1.19 released in April 2018.

A total of six new items have been added to the latest version of the manual:

Borderline – medical intended purpose

1. Mattress covers against mites; although mattress covers could be part of the treatment plan of patients suffering from allergy, the cover – under the bedlinen – is not acting directly acting on the patient; it acts on the mites. Therefore this product should not be considered a medical device. Emergo comment: this is a useful illustration of how the definition of a medical device should be applied.
2. Lubricants intended for body massages and/or sexual intercourse; lubricants can be used for alleviation of vaginal dryness should be considered medical devices. The same goes for lubricants specifically intended by the manufacturer to be used together with a condom in order to enable it to function as intended. However, if they are only intended for body massage or to stimulate sexual intercourse they should not qualify as medical devices.

Classification

3. Trial hip prosthesis heads or stems; trial hip prosthesis heads or stems are used to determine the exact size of the prosthesis before the implantation of the definitive implant. These products should not be considered “reusable surgical instruments” because they are not used as part of a surgical procedure (cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures: see Annex IX, Chapter I, Section 1.3). Therefore Rule 6 applies: Class lla.

Software and mobile applications

4. Product intended to facilitate conception based on basal body temperature; this product uses body temperature and information on the menstrual cycle for predicting ovulation in order to facilitate conception. It is not intended to be used for prevention of conception. Therefore this is considered an active device to which Rule 12 applies: Class I.
5. Product intended to facilitate conception and enable contraception based on basal body temperature; this is almost the same intended use as the above mentioned device. However, this product is also intended to be used for prevention of pregnancy. Therefore Rule 14 applies and this should be considered a device of Class llb.
6. Stand-alone software application for conception and contraception purposes using data entered by the patient; this device has the same medical claims as the above mentioned device, but this device relies on the user manually entering all data, including body temperature measured with a normal thermometer. For this device too, Rule 14 applies: Class llb.

MDR: similarities and differences

With just over 18 months until the date of application of the Medical Devices Regulation (MDR), it is also interesting to see how these cases would work out under the new legislation:

1. Mattress covers against mites; no difference under the MDR: not a medical device.
2. Lubricants intended for body massages and/or sexual intercourse; no difference under the MDR: the “medical” claims result in a status as a medical device.
3. Trial hip prosthesis heads or stems; no change under the MDR, therefore Rule 6 applies: Class lla.
4. Product intended to facilitate conception based on basal body temperature; under the MDR the classification may change. Rule 11 is about “Software,” but does not explicitly limit its use to software as a medical device. If that understanding of the rule would be correct, all devices incorporating software would have to be classified according to Rule 11 as well. For such devices, this would result in Class lla, as an error in this software in the worst case would result in no pregnancy. This is not a serious deterioration of the state of health of the user. In case Rule 11 does not apply, Rule 13 applies: Class I.
5. Product intended to facilitate conception and enable contraception based on basal body temperature; here too, the question is if Rule 11 would apply. If it does, there is an ethical question: how should an unwanted pregnancy be determined? Is this an “irreversible deterioration of person’s health” or a “serious deterioration of a person’s health?” This would make the difference between Class lll, Class llb. This is not clear and additional guidance is needed. If Rule 11 does not apply, Rule 15 would apply: Class llb.
6. Stand-alone software application for conception and contraception purposes using data entered by the patient; for this device the same issue applies as above: Class lll or Class llb, depending the understanding of the classification rules.

The above issues illustrate that some cases in the current Manual on Borderline and Classification can be used for the MDR. However, this should always be done with great care. There are differences and, especially for IVDs, the classification rules have significantly changed.

Additional European medical device and IVD regulatory information from Emergo by UL:

• European CE Mark strategy for medical device manufacturers
• CE Mark strategy for IVD device manufacturers
• European medical device classification consulting
• European Authorized Representative in-country representation
• On-site MDR training for medical device manufacturers
• Whitepaper: Understanding Europe’s MDR