In accordance with the Medical Device Regulation, manufactures must show that devices are safe and perform as intended, taking into account the generally acknowledged ‘state of the art’. This term can also be found in the MEDDEV 2.7/1 rev 4 guidance, which guidance also demands that the manufacturer presents a thorough description of the state of the art and current knowledge related to the subject device. As of lately, we have been seeing many notified bodies focusing on this requirement, and many manufacturers are finding it difficult to understand what is required of them. So, what exactly is needed to meet this requirement?
Firstly, it is important to note that the MDR does not specifically define the term ‘state of the art’. Many other (non-legally binding) EU documents provide references, definitions and practical examples which are useful to consider (refer to MDCG 2021-5 for more information on this). For the purpose of addressing the requirements related to the state of the art in relation to the MDR, maybe the best definition is found in MDCG 2020-6: The state-of-the-art embodies what is currently and generally accepted as good practice in technology and medicine. The state of-the-art does not necessarily imply the most technologically advanced solution.
What is understood from all the above, and what Notified Bodies are expecting, is that the manufacturers present information regarding the generic device, and use that information to compare it with the clinical data of the subject device to show that the subject device is safe, performs as intended and the benefit risk ratio is acceptable. Let’s look into this requirement a bit more in detail.
Firstly, one needs to present information regarding the generic device. In accordance with MEDDEV 2.7/1 rev 4 Section 8.2, the clinical evaluation should include a section discussing the generally acknowledged state of the art (related to the subject device) retrieved from literature. A literature methodology should be presented including a search protocol (refer to MEDDEV 2.7/1 rev 4 Appendices A5 and A6). From this literature search, one should be able to provide a description of the device and the intended use of the device, the procedure in which it is utilised, information on the relevant medical conditions, complications or risks associated with the device, and information on similar devices on the market as well as alternative technologies / devices. If possible, one should also include applicable standards and guidance documents.
Secondly, one needs to use that information to compare it with the clinical data of the subject device. This is related to another requirement as detailed in Annex XIV Part 1a indent 4 for the Clinical Evaluation Plan; the manufacturer should identify the clinical benefits of the device with relevant specific clinical outcome parameters. A clinical benefit is ‘expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s)’ as defined in Article 2(53). These measurable outcomes, or endpoints, should be identified from the state of the art search (refer to MDCG 2020-13 Section C) and should be related to safety, performance and the benefit risk. These endpoints identified from the SOTA search will then compared to the same endpoints related to the subject device, presented either from testing that the manufacturer himself conducted, or from a literature review.
To recap the above in simpler terms – manufacturers need to present specific or measurable endpoints related to their clinical benefit, which endpoints need to be identified from the state of the art and subsequently compared to the endpoints from the subject device.
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