We are currently witnessing a change in the regulations for 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 Device Regulation 2017/745 (MDR) next May 2021.
As we have already commented in other entries, 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 to the way medical device manufacturers gain access to the European market, including the way Clinical Evaluation Report of the medical device is carried out.
WHAT ELEMENTS MUST A CLINICAL EVALUATION HAVE TO COMPLY WITH THE REGULATIONS?
Medical device regulations do not specify exactly how a clinical evaluation should be structured. But it does make clear the elements that must be taken into account. Therefore, having the experience of having carried out a clinical evaluation that complies with the directive is an advantage to face the drafting of this under the regulation.
First of all, it is necessary to be clear about what kind of medical device we want to certify. If it is class III or it is an implantable product, the evaluation must be based on data obtained by 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 comparing it 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 object of our evaluation. Once the equivalent has been found, a detailed study of the technical, clinical and biological characteristics must be carried out.
Once we have justified the equivalence, we will have to search the scientific literature for clinical data that supports the safety and efficacy of our product. For this, it is important to follow the specific guidelines written by the Medical Device Coordination Group.
Lastly, a post-market follow-up plan must be developed. With this, the relevant data regarding the post-production and commercialization of the device is obtained.
At I3CGLOBAL Consulting we know first-hand the doubts that can arise when facing a task as big as writing a clinical evaluation for a technical report, but it's easy if you know how!
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