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Authors: <\/strong><\/p>\n Miriam Schulze <\/strong>CEO of BAYOOMED<\/p>\n Julia Schliesch <\/strong>Marketing Generalist at BAYOOMED<\/p>\n<\/div> The European Commission has submitted a proposal to amend the MDR and IVDR with the aim of simplifying regulatory requirements for medical devices. The focus is also on the application of MDR Rule 11 on the classification of software. The background to this is ongoing concerns that the existing regulations are often too complex, cost-intensive and difficult to plan for manufacturers. <\/p>\n Classification as Class I would have tangible benefits for manufacturers in particular: The involvement of notified bodies would not be necessary, which would reduce costs and additional regulatory work. At the same time, market entries, updates and further developments could be implemented much more quickly. Against this background, the European Commission’s proposal to revise Rule 11 is of particular importance. A clearer and more practical formulation could increase legal certainty and strengthen innovation and planning security in the field of medical software. <\/p>\n<\/div><\/div><\/div><\/div><\/div> <\/p>\n Since the MDR came into force, there have been clear challenges in practice:<\/p>\n<\/div> long certification times,<\/p>\n<\/div>\n<\/div><\/li> Bottlenecks at notified bodies,<\/p>\n<\/div>\n<\/div><\/li> high regulatory burdens, especially for small and medium-sized manufacturers,<\/p>\n<\/div>\n<\/div><\/li> Ambiguities and different interpretations of central regulations,<\/p>\n<\/div><\/li> Risks due to the potentially limited availability of medical devices in Europe.<\/p>\n<\/div><\/li><\/ul> The European Commission is responding to these developments with the new draft. The explicit aim is not to lower safety standards, but to create a more practical and manageable legal framework that enables innovation while ensuring security of supply. <\/p>\n<\/div><\/div><\/div><\/div><\/div> <\/strong><\/p>\n Previous application<\/strong><\/p>\n Until now, MDR Rule 11 was interpreted in such a way that software was first checked to see whether it supported diagnostic or therapeutic decisions. If this was the case, it was generally classified as Class IIa, IIb or III. Only software without a corresponding reference was assigned to class I. <\/p>\n The main problem with this system was the considerable scope for interpretation. In practice, there are different opinions as to whether software can be classified as Class I at all. While some stakeholders assume that practically all medical software is at least Class IIa, others take the view that diagnosis and treatment are carried out exclusively by doctors and that purely patient-focused applications can therefore continue to be Class I. <\/p>\n The MDCG document MDCG 2019-11 Rev. 1 in particular should help to clarify these questions. However, the examples of stand-alone Class I software mentioned there, such as an application for determining fertile days or a communication aid for people with speech disorders, are very narrowly defined and offer only limited guidance for other use cases. For many software products, particularly in the field of digital health applications, the classification issue therefore remains unclear. <\/p>\n<\/div> New approach in the Commission draft<\/strong><\/p>\n The new draft reverses the previous logic of MDR Rule 11. In future, medical software will generally be classified as Class I unless clearly defined escalation criteria are met. Upgrading will only take place if the risk to patient safety associated with the software justifies this. <\/p>\n<\/div> Excerpt from the draft (Rule 11):<\/strong><\/p>\n “Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended for a disease or condition:Why has the EU revisited the MDR?<\/strong><\/h2><\/div>
MDR Rule 11: What was it like before? What’s new? <\/strong><\/h2><\/div>
– in a critical situation with a risk of causing death or an irreversible deterioration of a person’s state of health (class III);
– in a serious situation with a risk of causing a serious deterioration of a person’s state of health or a surgical intervention, or to drive clinical management in a critical situation (class IIb);
– in a non-serious situation, or to drive clinical management in a serious situation or to inform clinical management in a critical or serious situation (class IIa).”<\/p>\n