- The Medical Device Coordination Group has published an extensive guide to the classification of medical devices in the European Union.
- Across the 57-page document, MDCG sets out how to classify medical devices, provides rules to inform the process and describes the impacts of the classification on pre- and postmarket regulatory requirements.
- The publication of the medical device document comes almost one year after the release of classification rules for in vitro diagnostics under the incoming regulations and fills a gap in the MDR guidance.
MDR divides up devices into four categories, class I, IIa, IIb and III, based on their intended purpose and inherent risks. Manufacturers need to propose and justify the risk class of their devices in their technical documentation. The European Union has already provided rules for classification in a MDR annex. MDCG's guidance fleshes out the MDR annex to help manufacturers follow the rules and understand the implications of their classification.
The guidance details how to carry out classification by explaining terms such as "duration of use" and "invasiveness." Having clarified what the terms mean, the guidance explains the application of the classification rules, including through a practical example.
MDCG cites a simple wound drainage system that consists of a cannula, tubing and collector unit as an example of how to apply the classification rules. As the tubing and collector are non-invasive, they are subject to rule 1 and put into class I. The cannula, in contrast, is surgically invasive, meaning it is subject to rule 7 and put in class IIa. In that situation, the manufacturer could apply class IIa to the whole device or carry out separate conformity assessment procedures for the class I and IIa parts.
The guidance acknowledges that, while the rules "adequately classify the vast majority of existing devices," a "small number" of products may be harder to categorize. If a manufacturer and notified body dispute a classification, the case may be referred to the competent authority in the country where the manufacturer has its registered place of business.
MDCG devotes much of the rest of the guidance to explanations of the 22 classification rules set out in MDR. In each case, the coordination group provides a general explanation of the rule before describing the sub-rules and the risk classes they fall into. For example, surgically invasive devices intended for short-term use are subject to rule 7, meaning they are class IIa unless they have certain purposes or features that can elevate them into class IIb or III.