A comprehensive guide to medical device classification EU was published on October 20, 2021 by The Medical Device Coordination Group (MDCG). MDCG guidelines are detailed in a 57-page document, detailing how medical devices are classified, and providing rules to help in this process. The document also discusses how the classification affects pre- and post-market regulatory requirements.
The EU medical device legislation classifies medical devices according to their potential risks and the vulnerability of the human body. Using this classification system, medical devices are classified according to risk factors. A device is classified according to a set of criteria, such as how long it is in contact with the body, the extent of its invasiveness, local or systemic effects, potential toxicity, the region of the body it affects, and whether it is powered by another source of energy. These criteria are referred to as classification rules and are described in the MDR Regulation (EU) 2017/745.
MDR requires that all devices comply with all relevant requirements, regardless of their categories or classes.
According to MDR Article 51, medical devices are categorized into four classes based on their intended purpose and inherent risks – class I, IIa, IIb, and III. In their technical documents, manufacturers must include the risk class of their device, as well as the reasons for the classification. MDCG’s guidance is based on the MDR annex that the European Union has already provided classification rules in order to help manufacturers comply with the rules and understand the ramifications of their classification.
A practical example is provided to illustrate how the terms duration of use and invasiveness are used to carry out classifications. Once the terms are explained and clarified, the guidance explains the application of the classification rules.
An example of how to apply the classification rules according to MDCG is a simple wound drainage system consisting of a cannula, tubing, and collector unit. Tubing and collectors are non-invasive, so they are categorized under class I and are subject to rule 1. On the other hand, the cannula is surgically invasive, so it falls under rule 7 and is classified as class IIa. As a result, the manufacturer could apply class IIa to the whole device or carry out separate conformity assessment procedures for the class I and IIa components.
In the guidance, it is acknowledged that, while the rules “adequately classify the vast majority of existing devices,” a “small number” of products might be more difficult to classify. If there is a disagreement between the manufacturer and the notified body about classification, the case may be referred to the competent authority in the country where the manufacturer is registered.
In MDR, there are 22 classification rules. MDCG provides further guidance regarding each of these rules. The coordination group describes in each case the sub-rules and the risk classes they belong to before explaining the general rules. Surgically invasive devices intended for short-term use, for example, fall under rule 7. In other words, they are class IIa unless their purposes or features qualify them for class IIb or III.
Do you want to learn more about the new rules under the Medical Devices Regulation, talk to one of the MDR specialists today!
