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Europe: New MDCG guidance shows how devices fit into MDR’s classification rules

2021/10/07  EC

1 Purpose of medical device classification
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness, local vs. systemic effect, potential toxicity, the part of the body affected by the use of the device and if the device depends on a source of energy. The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:2012.

2 Practical relevance of classification
The purpose of this chapter is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements. The explanations provide some simplified concepts and are not exhaustive. For details see the MDR and related additional guidance.

2.1 General requirements
Irrespective of the class of the device, all devices must comply with all relevant obligations of the MDR. However, some requirements depend on the device classification.
For example, the devices must:

  • meet the general safety and performance requirements, including the requirements regarding the information to be supplied by the manufacturer (Annex I of the MDR);
  • be subject to the reporting requirements under the medical device vigilance system;
  • be CE marked (except custom-made devices and devices intended for clinical investigation, in which case they should comply with the provisions of respectively Art. 52.8 and Annex XIII or Articles 62 – 80, 82 and Annex XV);
  • be assigned a Unique Device Identifier (UDI) number and be registered in the electronic system, in accordance with MDR Article 29;
  • if the device is implantable, be supplied with an implant card and information to the patient in accordance with Article 18.

According to MDR Article 51 devices are divided into the following classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification is to be carried out in accordance with Annex VIII to the MDR. In addition, and according to Article 52(7)(a), (b) and (c), Class I devices can be further subdivided into Is – sterile condition, Im – measuring function and Ir – reusable surgical.

The technical documentation to be drawn up by the manufacturer must include the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII of the MDR.

Sections 2.2-2.6 give an overview of some requirements that depend on the class of the device. For detailed and exhaustive provisions on each topic, refer to the MDR, as well as to dedicated guidance where available.

Annex XVI products should be classified in accordance with the classification rules in Annex VIII of the MDR and taking into account possible provisions within the relevant implementing acts covering Annex XVI devices.

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