As a solution provider, EDUCE offers effective strategy beginning with Gap Analysis of all available data from clinical to safety to risk management to literature before arriving on right CEP. Based on the designed plan, next steps of execution are undertaken with right teams to ensure scale, speed and quality of the report.
Clinical evaluation is a structured continuous procedure to collect, appraise and analyze clinical data pertaining to a medical device and this evaluation should be documented in the form of an report to support initial CE-markings .
The guideline determining the structure and content of the CER is MEDDEV 2.7/1 Rev. 4 ( June 2016). MEDDEV 2.7/1 Rev. 4 gives some indications for a structure for the report. since the introduction of MEDDEV 2.1/7 rev. 4.
A literature search is required in order to determine the state of the art for the subject device. This literature search is separate from the systematic literature search conducted to appraise the subject device.
The stages of clinical evaluation are presented in Figure below.
|2. Scope of the clinical evaluation|
|3. Clinical background, current knowledge, state of the art|
|4. Device under evaluation|
|     4.1 Type of evaluation|
|     4.2 Demonstration of equivalence (only if claimed)|
|     4.3 Clinical data generated and held by the manufacturer|
|     4.4 Clinical data from literature|
|     4.5 Summary and appraisal of clinical data)|
|     4.6 Analysis of the clinical data|
|           4.6.1 Requirement on safety|
|           4.6.2 Requirement on acceptable benefit/risk profile|
|           4.6.3 Requirement on performance|
|           4.6.4 Requirement on acceptability of side-effects|
|6. Date of the next clinical evaluation|
|7. Dates and signatures|
|8. Qualification of the responsible evaluators|