The conformity assessment procedure comprises any procedure used to determine that a medical device fulfills the Technical Regulation requirements and standards.
According to TRs, medical device classification (Class I, IIa, IIb, III, List A and B, etc.) defines the conformity assessment procedure. These procedures can include self-declaration, QMS audit, CE Certificate recognition, batch certification, etc.
- The manufacturer is allowed to self-declare (through the CA mark) a medical device that is classified as the Class I (low-risk) device. However, in the case, if a device has a measuring function or is supplied as a sterile device, a CAB is required.
- For Class IIa (low- to medium- risk), Class IIb (medium- to high-risk), and Class III (high-risk) devices, a CAB audit is essential to check the quality system. The manufacturer can independently choose an audit to proceed with the CA marking.
- For Class III devices, a CAB evaluates the design of a medical device by reviewing the technical documentation submitted by the manufacturer and issues the CA mark following the Technical Regulations.
- Active Implantable Medical Devices (AIMD) are considered as Class III (high-risk) devices. Therefore, they must undergo Full Quality Assurance (examination of the design and post-market surveillance).
The manufacturer is required to submit the technical documentation of a medical device (safety and performance claims) to the CAB. The depth of the technical documentation review conducted by the CAP is entirely dependent upon the classification of the device, as defined by the corresponding Technical Regulation.
In case of QMS audit, the CAB will determine the number of audit days and specific sites that should be inspected only after the complete draft application has been submitted.
Be aware that once the manufacturer has submitted a signed application, it is not allowed to provide the same request to any other CAB.
In Ukraine, the conformity assessment certificate of a medical device is valid for 5 years. Please note that the CAB of Ukraine will conduct annual audits throughout the validity period.
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