EC Manual on Borderline & Classification - New interpretative rules for digital health technologies, trial hip prosthesis, anti-allergy mattresses and lubricants

On 30 October 2018, the European Commission (EC) published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (version 1.20) (the Manual). This is the second time the EC updates the Manual this year, after the last revision took place in April 2018 (version 1.19).

The Manual serves “as a tool for the case-by-case application of community-legislation by the Member-States”. It interprets the rules of the current European MDD1, AIMD2 and IVDD3, but does not cover the new definition of a “medical device” and classification rules introduced by the European regulations of 25 May 2017 (MDR4 and IVDR5).

The EC Manual includes several new cases, which are addressed hereunder.

Software and mobile applications concerning conception and/or contraception

The first new case with a software component discussed in the Manual is an invasive active medical device intended, via a single piece of equipment, to (i) measure and record the daily basal body temperature orally, and (ii) use the basal body temperature against menstruation days to track the menstrual cycle and predict users’ ovulation.

While the outcome (fertility status) is reflected by one of three coloured indicator lights (red / yellow / green), the device does not display the user’s temperature and is not intended to allow direct diagnosis or monitoring of the body temperature (ie a vital physiological process6). The manufacturer claims that the device facilitates conception by predicting ovulation.

Based on the current MDD, the Manual takes the approach that the residual rule for active medical devices applies (Rule 12 – Class I).7 The interest of this guidance in a pre-MDR context is limited as the combination of Rule 5 (Invasive devices connected to an active device) and Rule 11 (Software) of the MDR will likely result in a higher class under the upcoming regime. It should be noted that very few software technologies with a medical purpose are expected to retain a Class I status (with a few exceptions, eg software involving an Annex XVI product) under the MDR and manufacturers should prepare accordingly.

The second case discussed in the Manual is an equipment (invasive active medical device) that is exactly identical to case (i) above, but with different claims. Instead of claiming that the device facilitates conception by predicting ovulation, the manufacturer alleges that the product facilitate conception and/or prevents pregnancy. Such contraception claim results, according to the Manual, in a Class IIb classification in accordance with Rule 14 of the MDD and MEDDEV 2.4/1 Rev. 9.

The same rule is echoed by the MDR (Rule 15).8

The Manual also addresses the case of a stand-alone software ("SaMD under the MDD / Medical Device Software under the MDR") intended to prevent pregnancy and/or facilitate conception. The software collects users’ input data on the following parameters with a view to obtaining the user’s fertility window:

  • the first day of menstruation
  • the daily basal body temperature measured by the user with a common thermometer, and
  • consistency of the cervical mucus checked by the user.

Under the MDD, the Manual concludes that such app should be classified as Class IIb in accordance with Rule 14 of the MDD and MEDDEV 2.4/1 Rev. 9.9

Under the MDR, the special rules (eg Rule 15 on contraception or prevention of STDs) could also apply to (stand-alone) Medical Device Software such as a contraception app marketed in the EU. However, a case-by-case basis applies and, depending on the outcome of the information provided by the app (eg information used to take decisions with diagnosis or therapeutic purposes), such device could be classified in a higher class pursuant to Rule 11 and Annex VIII, 3.5.10 in this regard, IMDRF guidance11 will prove useful to assess the level of risk incurred by a situation or condition.

Mattress covers against mites

Where manufacturers claim that (i) a mattress cover protects users from allergens in the mattress, and that (ii) consequently users will be able to use any bed with the cover without onset or progression of the symptoms of mites’ allergy, the EC considers that the product should not be qualified as medical device. According to the Manual, “a mattress cover does not alleviate the allergic disease. It constitutes only a barrier between the user and a part of its environment protecting him from allergens”. The fact, alone, that the mattress may be part of a treatment plan for allergic patients is not sufficient to qualify the product as a device.12

Of note, this interpretation is not included in the Manual’s section on "Borderline medical device - biocides" but in the general section on "Medical Device/In Vitro Diagnostic Medical Device - Medical Intended Purpose", which merely interprets the definition of a medical device under the MDD / IVDD.

The Manual takes the approach that mattresses themselves do not alleviate allergic diseases and only constitute a barrier against the user’s allergenic environment, without considering the effect achieved by such products, which is the reduction of allergic symptoms. This guidance may have consequences for those manufacturing bed covers used in anti-allergic treatments and marketing them as medical devices in some Member States, with the caveat that it is for the national competent authorities and national courts to assess on a case-by-case basis.

Lubricants intended for body massages and/or sexual intercourse

Three cases are distinguished in the Manual:13

  • lubricants intended to be used for body massage or to stimulate sexual intercourse (ie non-medical purpose), which should not be qualified as medical devices
  • lubricants intended by their manufacturers to allow a medical device (eg condom) to function as intended, which should be qualified as an accessory to medical device, and
  • lubricants intended by the manufacturer for the alleviation of vaginal dryness, or for other medical purposes, which should be qualified as medical devices.

Trial hip prosthesis heads or stems

Trial hip prosthesis heads or stems are used during surgery to determine the exact size of the prosthesis before the definitive implant is implanted by the surgeon. The Manual clarifies that the intended purpose of these medical devices is such that they cannot be considered "reusable surgical instruments" for the purpose of Annex IX, 1.3 of the MDD.14 Accordingly, the general classification rule provided under Annex IX, 2.2 ("Rule 6: All surgically invasive devices intended for transient use are in Class IIa unless they are: …") applies and excludes the Class I regime of reusable surgical instruments.

1. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
2. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
4. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
5. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
6. MEDDEV 2.4/1 Rev. 9, page 43, note 1
7. Manual, 9.9
8. Manual, 9.10
9. Manual, 9.11
10. Annex VIII, 3.5 of the MDR: "If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply."
11. See for example : IMDRF, "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations, 18 September 2014
12. Manual, 1.25
13. Manual, 1.26
14. Manual, 8.31

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