Market access

Affixed CE mark at the product labeling, as well as availability of documents confirming compliance with the European Directives for medical devices or approval of devices sale on the European markets, does not authorize placement of the product on the Ukrainian market without passing the national conformity procedure. Moreover, previous registration does not facilitate this process and the results of technical, preclinical or clinical examinations do not provide confirmation of conformity to Technical Regulations.

The European conformity assessment route suggests approach to the procedure in Ukraine. It will be efficient to follow EU procedure and decisions, using almost identical documentation to simplify national conformity assessment procedure.

All medical devices that should be put into market from July 01, 2915 for the first time – national conformity assessment to Technical regulations (Decrees of Cabinet of Ministers of Ukraine №753, №754, №755 dated October 02, 2013) is required. 

Procedure of national conformity to Technical regulations depends on class of medical device and allows for some classes to choose between inspection and laboratory testing. 

Class of medical device defines necessity of involving of authorized (notified) body: safest products can be introduced to the market through self-declaration conformity procedure to Technical regulation of Ukraine. Other medical devices require either assessment of documentation and 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.

Self-declaration is applied to:

Medical devices of I class, not sterile, without measuring functions according to provision of Technical regulation on medical devices (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 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);