Clinical evaluation is defined as a systematic, planned process for generating, collecting, analyzing and continuously assessing clinical data relating to a device in order to verify its safety and performance, including clinical benefits, when used in accordance with the manufacturer’s intended purpose.
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This clinical evaluation can be planned right from the device design stage. It will consist of carrying out a state-of-the-art assessment of the device in question, which will make it possible to:
- Define performance, benefit and safety data requirements;
- In the case of possible equivalence, assess whether these clinical data are valid and determine equivalence;
- Define the need for additional clinical data.
The new Regulation 2017/745/EU changes the requirements in terms of clinical evaluation, which becomes a subject in its own right. Clinical evaluation is now organized into two documents: the Clinical Evaluation Plan and the Clinical Evaluation Report.
Performance and benefit claims will condition all clinical data. Indeed, once these claims have been determined, all sources of clinical data will focus on them, in order to verify that they are covered by sufficient clinical data. Safety claims must also be defined, but the clinical evaluation must highlight all the risks associated with the device and procedure.
If claims are partially covered, a list of unanswered questions is drawn up at the end of the clinical evaluation. These will need to be answered during post-market clinical surveillance (PMCS).
- The clinical evaluation strategy (refer to the clinical evaluation strategy page).
Once these two points have been established, the identification, analysis and critical evaluation of the data can begin.
The clinical evaluation must be a critique of all the results highlighted, and must take into account the alternatives to the treatment under study that are currently available (state of the art).
With regard to equivalence, the manufacturer must provide proof of sufficient access to data on the device with which equivalence is claimed. When the so-called equivalent device belongs to the manufacturer, access is generally easy to justify. In the case of equivalence with a competitor’s product, this justification is immediately more complex. For implantable and class III devices, equivalence with a competitor’s product must be the subject of a contract between the two manufacturers, giving the former full and permanent access to the technical documentation of the equivalent device.
- Consumables (urine protectors, wound treatment kits, filters for ventilation systems);
- Instrumentations (orthopedic ancillaries, spine ancillaries, microsurgery kit, endodontic instruments);
- Equipment (medical gas sheaths, OR lighting,
- Disinfectants;
- Medical device software (Prescription assistance software, Dispensing assistance software, Pathology management assistance software, Cardiovascular pathology diagnosis assistance software);
- Orthopedics (total hip prostheses, osteosynthesis screws, intramedullary implants, total wrist prostheses, bone substitutes);
- Spine (fixation systems for spinal deformities, intervertebral cages);
- ENT (suction cannula, surgical robot) ;
- Ophthalmology (ophthalmic implant, implant injector, scleral implant, ptosis probe, cryodes);
- Other implants (breast implants, Russian thread).
It is part of the Post-Market Surveillance (SAC) plan established by the manufacturer. Under SCAC, the manufacturer proactively collects and evaluates clinical data resulting from the use in or on humans of a device that bears the CE mark and is placed on the market or put into service in accordance with its intended purpose . , as provided for in the corresponding conformity assessment procedure, with the aim:
- to confirm safety and performance over the expected lifetime of the device;
- to ensure the continued acceptability of identified risks;
- detect emerging risks based on concrete evidence.
The SCAC is organized into two documents: the SCAC Plan and the SCAC Assessment Report. The conclusions of the SCAC evaluation report are taken into account in the clinical evaluation.