At July 01, 2015 marketing authorization requirements for medical devices have changed: system of state registration has been replaced by national conformity assessment to Technical regulations. Ukrainian Technical Regulations are based on relevant EU Directives 93/42/EEC, 98/79/EC and 90/385/EEC.
| Regulatory framework
-assessment conformity of medical devices – resolution by Cabinet of Ministry of Ukraine №753 from 02.10.2013,
-assessment conformity of in vitro diagnostic devices – resolution by Cabinet of Ministry of Ukraine №754 from 02.10.2013,
-assessment conformity of active implantable devices – resolution by Cabinet of Ministry of Ukraine №755 from 02.10.2013.
Procedure of national conformity to Technical regulations depends on class of MD and allows for some classes to choose between factory inspection and batch verification.
Class of MD defines need for involving of notified body: safest products can be put into the market through self-declaration conformity procedure to Technical regulation of Ukraine. Other MD require documentation assessment and factory inspection of the manufacturing site that will grant certificate for 5 years, or to follow every-batch conformity assessment that result to certificate for exact shipment.
Conformity assessment involving authorized body is required for:
-Sterile medical devices of I class, measuring medical devices, all medical devices of classes IIa, IIb, III according to provision of Technical regulation on medical devices (Decree of CMU №753),
-In-vitro: self-testing devices; reagents, calibration and control materials of lists “A” and “B” of the Technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754),
-All active implantable medical devices according to Technical regulations on active implantable medical devices (Decree of CMU №754).
The conformity assessment procedure with the involvement of the notified body may be applied using one of the following routes:
- Assessment of the Quality Management System at the manufacturing site (factory inspection), which results in issuing of the conformity certificate for MD valid for 5 years related to the quality management certificate valid for 3 years.
- Conformity assessment of each batch, which mean issuing of the certificate for the certain batch (shipment) of MD after documentary expertise and sample examinations.
Self-declaration is applied to:
- Medical devices of I risk class, not sterile, without measuring functions according to provision of Technical regulation on MD (Decree of CMU №753);
- Analyzers, reagents and other IVD products, which are not included in the lists “A” and “B” of the Technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754)
Conformity assessment of manufacturer quality management system is more comprehensive, time-consuming and costly procedure in comparison with the batch verification procedure. But in the long term perspective the estimated costs for the fourth-fifth batch assessment may exceed those for manufacturing site inspection.