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In their technical documentation, manufacturers must suggest and justify the risk class of their products. In the MDR annex, guidelines for categorization have already been established by the European Union. The advice of MDCG expands upon the MDR annex in order to aid manufacturers to obey the regulations and comprehend the ramifications of their classification.
The guide describes how to classify words like “duration of use” and “invasiveness.” Once it has established the meanings of the terminology, the instruction provides a practical example of the implementation of the categorization criteria.
As an illustration of how to use the principles of categorization, MDCG quotes a simple wound drainage system consisting of a cannula, tubing and collector unit. Since the collector and tubing is non-invasive, they are subject to rule 1 and placed into class I. The cannula, however, is surgically invasive and is therefore subject to rule 7 and class IIa. In this case, class IIa could be used for the complete device or separate conformity assessment processes may be applied for the class I and IIa sections.
The guidelines recognise that while the standards “adequately classify the vast majority of existing devices,” the categorization of a “small number” of items may be more difficult. If the manufacturer and the notified body disagree with the categorization, the issue can be submitted to the competent authority of the nation in which the manufacturer is registered.
MDCG dedicates a large part of the remainder to clarifying the 22 MDR rules of categorization. In each case, before presenting the sub-rules and the risks classes in which they fall, the coordination group offers an overall explanation of the rule. For example, short-term surgically invasive devices are subject to Rule 7, that is to say Class IIa, unless they have specific objectives or characteristics that might lead to class IIb or III applications.
Earlier this year, the European Commission revealed its proposals to regulate AI, including medical devices and in-vitro diagnostics that use it. To be eligible for EU approval, high-risk AI systems must “comply with certain mandatory requirements” before they can be put on the market. They agreed that existing laws may be impacted, but saw their framework as complementing existing regulations like the Medical Devices Regulation.
MedTech Europe, on the other hand, believes that the plan falls short of that ambition. Medical technology companies in Europe, via their trade group, complained to the European Commission about apparent “misalignment” between MDR and IVDR, as well as with the Artificial Intelligence Act (AIA). According to MedTech Europe, the misalignments would have significant implications.
In a statement, MedTech Europe explained: “There are concerns that the AIA would in effect create the need for manufacturers to undertake duplicative certification/conformity assessment, via two Notified Bodies, and maintain two sets of technical documentation, should misalignments between AIA and MDR/IVDR not be resolved. Duplication of this kind would lead to unnecessary overlaps in the regulatory approval of AI as/in medical technology, which could have a negative effect on the timely access of citizens and patients to highly innovative and fairly priced AI medical technology in the EU.”
The Med-Tech World conference, which follows a successful digital event in 2020, will run from 18th-19th November 2021 and will highlight innovations and developments in digital health across the globe. With so many countries realising the potential for exponential growth, Med-Tech World will address the opportunities and challenges driving this multi-million forum – embracing the potential for technological innovation to change the face of medicine in this global sector. Register your interest here!