Classification of Medical Devices.
The Medical Device Coordination Group (MDCG) published an enlightening document with new tips and guidance for the Classification of Medical Devices.
MDCG included a set of examples which can be seen in the image below.
MDCG sets out how to classify medical devices, provides rules to inform the process, and describes the impacts of the classification on pre-and post-market regulatory requirements. The guidance provides a high-level overview of the regulations and graphical summaries to explain medical device classifications, showing how the 22 rules in Chapter 3 of the MDR that govern the categorisation of medical devices intersect with the four risk classes of medical devices and each other. It also offers extensive examples of the specific devices that fall into the four groups and into each of the 22 rules.
As we all know, MDR divides up devices into four main 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. This guidance provides a clear picture on how this classification process can function.
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.
With the publishing of the guidance, regulatory organisations were quick to provide comment and concerns. The Regulatory Affairs Professionals Society (RAPS) highlighted the following:
The guidance acknowledges that although existing rules cover the “vast majority of existing devices,” a “small number of devices may be more difficult to classify.”
Where disputes arise between the manufacturer and the notified body on the device’s classification, these cases should be referred to the competent authority of the Member State in which the manufacturer has its registered place of business. The competent authority will then render a decision on the device’s classification.
Separately, competent authorities may also ask the MDCG Borderline and Classification Working Group to discuss and review devices whose classifications are particularly complex. When the working group agrees on a classification of such a device, the group’s position is published in MDCG’s borderline and classification manual for reference.
The guidance is aligned with the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document issued by the Global Harmonization Task Force SG1/N77:2012.
These regulatory challenges can give rise to uncertainty but also unwanted clarity which may affect the operations of your organisation. Would you like to navigate these regulations efficiently?
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