Spotlight

Medical Device Classification System in the EU

Background #

Jurisdictions around the world use similar systems to categorise devices into distinct classes based on certain attributes such as risk. This allows regulators to easily assign each class a set of requirements and obligations which will need to be met.

However, before you begin classifying your device, you first need to make sure that your product actually qualifies as a medical device. To do this, we recommend first putting together a detailed intended purpose for your product and then qualifying it against the definition of a medical device as defined in Article 2(1) of the EU Medical Device Regulation 2017/745 (MDR).

The next step will be to determine the risk classification of your device in accordance with the classification rules in Annex VIII. Your device’s risk classification is crucial in determining the requirements which your device and organisation will need to meet, and will also have a major impact on the conformity assessment route chosen.

EU MD Classification System #

The classification system in the EU MDR is very similar to that found in the previous EU Medical Device Directive 93/42/EEC, however, there have been some key amendments and additions which have seen certain devices being up-classified into higher risk categories.

There are 4 main risk classifications, in increasing risk: Class I, Class IIa, Class IIb, and Class III. Class I devices may then be further split into 4 categories, depending on their attributes:

  • General or “simple” Class I.
  • Class I Sterile(s).
  • Class I Measuring(m).
  • Class I Reusable Surgical Instrument(r).

The selection of risk classification is not done arbitrarily based on a sense of the overall risk of the device. Instead, the MDR allows for a systematic approach to identifying the appropriate class using the Classification Rules of Annex VIII, which are split up into 4 sections:

  • Non-Invasive Devices [Rules 1-4]
  • Invasive Devices [Rules 5-8]
  • Active Devices [Rules 9-13]
  • Special Rules [Rules 14-22].

It is possible for a device to satisfy more than one rule, however, the highest resulting classification must be applied. The decision should be based on a robust description of the device’s intended purpose, including its indications, and its mode of action. Furthermore, the manufacturer shall put together a detailed rationale for the application of the chosen classification and provide a justification as to why the other rules in Annex VIII do not apply. This may form part of the Device Description and Specification section of the technical file, as indicated in Annex II of the MDR.

The EU Medical Device Coordination Group (MDCG) released the guidance document MDCG 2021-24 ‘Guidance on classification of medical devices’. It is highly suggested to consult this guidance document throughout the process of classifying your device. Another tip which may be helpful for those struggling to classify their device may be to search for similar devices which have been registered on EUDAMED, although this may not be a sufficient method in itself.

Key Mentions #

MDSW/SaMD: Rule 11 is reserved specifically for Medical Device Software / Software as a Medical Device. Depending on their intended purpose and mode of action, these may either be considered Class I, IIa, IIb, III. MDCG 2019-11 can be helpful in determining your classification.
Medicinal Product: Devices that incorporate a medicinal substance as an integral part, and which will have an effect ancillary to that of the device, will fall under Rule 14 and will classify as Class III medical devices. A good understanding of this rule will be vital to building a justification as to why this rule may not apply.
Nanomaterials: Any device which incorporates or consists of a nanomaterial will be required to consider Rule 19. The device’s potential for internal exposure will be a key determinant as to whether the product classifies as Class IIa, IIb, or III.

After the device classification has been determined, it may then be used to identify which conformity assessment procedure in Article 52 must be considered, and thus, which requirements will need to be met by the device.

How We Can Help #

We have a dedicated service in helping manufacturers identify the appropriate classification for their devices in our “Device Qualification and Classification” service. Take a look at our other services or get in touch today to learn how we may help you in all your regulatory needs!