THE CLASSIFICATION OF MEDICAL DEVICES (MDCG 2021-24)
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.
In this guidance is given a general overview on the impact of the classification of medical devices on different aspects of the device’s compliance with the legal requirements:
- all medical devices must comply with all relevant obligations of the Medical Device Regulation (MDR), however, some requirements depend on the device classification.
- 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.
- Demonstrating conformity is in the first instance the responsibility of the manufacturer and for most devices classes the conformity is then assessed by a notified body. The higher the class of the device, the greater the involvement of a notified body in conformity assessment. Annex I (general safety and performance requirements) and Annexes II (technical documentation) and III (technical documentation on post-market surveillance) apply to all devices regardless of class. Further relevant conformity assessment procedures (laid down in Annexes IX to XI) will depend on the class of the device.
- For any device regardless of class, the manufacturer must ensure the general safety and performance requirements are satisfied (MDR Article 5, MDR Annex I). This includes carrying out a clinical evaluation (MDR Article 5 (3), MDR Article 61, MDR Annex XIV.
- The manufacturer must update the clinical evaluation with clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up.
- Traceability, for class III implantable devices, economic operators and health institutions are obliged to have a record of the UDI of the devices they have supplied or with which they have been supplied (MDR Article 27). For class II and III devices, the economic operator is obliged to provide information on the Member State(s) where the device is or is to be, made available when registering the device (Annex VI Part A 2.4). In the case of implantable and class III devices, the economic operator must provide a summary of safety and clinical performance (Annex VI Part A 2.14). For single-use class I and IIa devices packaged and labelled individually, the UDI carrier does not have to appear on the packaging but must appear on a higher level of packaging (Annex VI Part C 4.3).
- Generally, instructions for use must be supplied together with the device. By way of exception, class I and IIa devices may be supplied without instructions for use if such devices can safely be used without the instructions and no other provisions of Annex I Section 23 state otherwise.
Before applying the classification rules, the manufacturer should first determine if the product concerned, based on its specific medical purpose, falls in the scope of the MDR as a medical device, accessory for a medical device (Article 2 MDR), medical device part or component for replacement (Article 23(2) MDR) or as a device without an intended medical purpose listed in Annex XVI.
It is the intended and not the accidental use of the device that determines the class of the device.
In case several rules, or if, within the same classification rule, several sub-rules, apply to the same device based on the device intended purpose, the strictest rule and sub-rule resulting in higher classification will apply.
In addition to the classification rules set out in Annex VIII of MDR, the manufacturers must also take account of any applicable legal acts and consider guidance documents that may support the classification of their device.
In the guidance are presented explanations of individual rules with different graphical summaries.
Link for the Guidance: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf