I am very happy that as of April, we have more time until the date of application of the Medical Device Regulation, as well as more clinical guidance to work with. In my previous post I addressed my observations on the guidance for the clinical/ performance evaluation of Medical Device SoftWare, in this one I will focus on the one for equivalence (MDCG 2020-5).
MEDDEV 2.7/1 REV 4
This guidance provides directions on the use of clinical evidence from equivalent device(s) for the purpose of the clinical evaluation. While highlighting and clarifying the differences, it uses MEDDEV 2.7/1 Rev 4 as a basis; which is great, since we are all familiar with that one and we updated (almost) all our clinical evaluations accordingly, right?
In fact for information on how to analyze clinical data from scientific literature it actually refers one to it, so we still need the current MDD guidance. Mind you, there is a conditional note though that
“In the event that the data do not meet the MDR definition of clinical data these are not clinical data and cannot be subject to data appraisal, analysis and evaluation for the purpose of providing clinical evidence”,
and given the MDR definition of clinical data, I wonder where that leaves us with clinical experience collected via physician testimonials or surveys; a tool we have been using to quite some extent the last few years to collect clinical experience in daily practice in a low-resource-consuming fashion.
Good thing is, that, similar to the MDSW clinical/ performance evaluation guidance, pending the development and publication of further MDR/ IVDR guidances, it seems a good strategy to continue using the existing ones including those from the IMDRF as long as they are in line with the MDR/ IVDR.
Also conform MEDDEV 2.7/1 Rev 4, clinical, technical, and biological characteristics need consideration for demonstration of equivalence to another device with respect to safety and performance. At first sight the same as before, but here the devil is in the details since instead of similar some of the characteristics are explicitly mentioned as must be the same under the MDR. Especially the
are getting attention in this respect (3 pages!), and particularly noteworthy is the remark that
“the exceptions outlined in the MEDDEV 2.7/1 Rev 4, to NOT use the same materials are NOT acceptable under the MDR”
(capitals are not mine). So for biological characteristic to be considered equivalent the equivalent device should use the same materials or substances in contact with human tissue or fluids. The guidance also stresses that since processing may affect the materials, the assessment should concern the final device.
On the clinical characteristics the guidance emphasizes that for equivalence the devices shall have the same kind of user (underlining that it makes a big difference whether users concern HCP’s or lay people due to their knowledge and competences), and that the devices should be used for the same clinical condition or purpose. That a
needs to be performed within the context of a clinical evaluation is nothing new, but thus far this was to determine whether clinical data was sufficient to verify that the device is safe and performing. The current guidance adds in this respect (providing an insightful equivalence table as an example), that also a gap analysis has to be performed evaluating
“any clinically significant differences”,
and their possible impact on safety and performance (note that clinical significance is NOT the same as statistical significance, so obtaining expert input is essential here), but also that
“considerations of equivalence shall be based on proper scientific justification”,
telling me once more that showing equivalence is no longer a simple paper exercise, and one will not be able to get away with a simple statement saying that despite some small differences devices can be considered the same.
SUFFICIENT LEVEL OF ACCESS TO DATA
Another topic that received much attention since publication of MEDDEV 2.7/1 Rev 4 concerns the need for access to the technical documentation of assumed equivalent devices. Also here the MDCG 2020-5 guidance leaves no room for debate, and once more underlines that under the MDR a manufacturer must be able to demonstrate sufficient level of access to the data of the equivalent device, and that for Class III and implantables this means a contract must be in place with the manufacturer of the equivalent device allowing for ongoing access to the technical documentation.
Moreover for these devices the guidance requires that the
“clinical evaluation of the equivalent device has been performed in compliance with the requirements of the MDR”,
and that therefore equivalence with a device CE-certified under the MDD or AIMDD is no option. Basically making it almost impossible to bring Class III or implantable devices to the EU market on the basis of equivalence, unless the equivalent device concerns a modified version of a device already marketed by oneself.
In contrast for devices other that Class III or implantable devices , the equivalent device does not need to be CE-marked as long as clinical data are collected in line Good Clinical Practices and data are transferable to the EU population.
So while happy at first sight with a flood of MDR clinical guidance being published lately (another one on safety reporting in clinical trials was published this week), the details bring us back to earth, making one realize that clinical evidence has to meet higher, tougher standards, and that the reversed Christmas tree of clinical evidence with equivalence as its base has finally been brought down.
Feel free reaching out for a discussion on the above, or in case you need support with your clinical evaluation or investigation.