For the conformity assessment procedure of class I medical devices (except for sterile devices, reusable surgical instruments and devices with measuring function), the notified body does not have to be involved.
For other classes (class IIa, IIb, and Class III), the notified body will review the clinical evaluation reports and supporting data provided by the manufacturers as part of the clinical assessment procedure.
They verify and conclude whether the manufacturer followed relevant procedures, performed risk analysis and identified undesirable side effects, provided proper justification for benefits, risks and undesirable side effects, properly identified, appraised and analyzed the clinical data, provided sufficient clinical evidence related to the safety and performance and demonstrated the equivalence for the device under evaluation.
They also examine:
- whether PMS plan is provided and if it is adequate and appropriate,
- the areas in the clinical evaluation which need to be confirmed using PMCF,
- whether the PMCF plan is appropriate,
- Justification is given in case if PMCF is not necessary,
- identified the sources of data from the PMS system,
- whether risks are acceptable when weighed against the benefits and
- clinical performance of the device is achieved.
The notified body will confirm the validity of the manufacturer’s justification, estimate the associated risks, and finally write a Clinical Evaluation Assessment Report (CEAR) based on the assessment done.