06 Nov Does your clinical assessment meet the requirements of MDR 2017/745?
We are currently witnessing a change in the regulation of medical devices. The current Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/ECC) will be replaced by the European Medical Devices Regulation 2017/745 (MDR) in May 2021.
As we have already mentioned in other posts, in order for a medical device to be marketed in the European Union, it must comply with the CE marking according to the requirements of this new regulation. This will introduce major changes in the way medical device manufacturers gain access to the European market.
What elements must a clinical assessment have in order to be compliant?
The medical device regulations do not specify exactly how a clinical evaluation should be structured. But it does make clear the elements to be taken into account. Therefore, having the experience of having conducted a clinical assessment that complies with the directive is an advantage when dealing with the drafting of the directive under the regulation.
First of all, it must be clear what kind of medical device we want to certify. If it is a Class III or implantable device, the assessment should be based on data from a clinical investigation. This must be done specifically for the product in question (except for some cases, explained in the Regulation). In all other cases, the necessary clinical evidence can be obtained by comparison with equivalent products. In this case, we will have to find a device that is technically and/or biologically similar, with the same intended use. On the other hand, it must have at least the same characteristics as the one that will be the subject of our assessment. Once the equivalent has been found, a detailed study of the technical, clinical and biological characteristics must be carried out. Small differences must be properly accounted for in this study.
Once we have justified the equivalence, we will have to look for clinical data in the scientific literature to support the safety and efficacy of our product. To this end, it is important to follow the specific guidelines drawn up by the Medical Device Coordination Group.
Finally, a post-market follow-up plan should be developed. With this, the relevant data regarding the post-production and marketing of the device is obtained.
At EpisKey Medical Consulting S.L. we know first hand the doubts that can arise when faced with such a big task as writing a clinical assessment for a technical report, but it’s easy if you know how!