The possession of a CE Certificate does not provide any benefits – Ukrainian legislation requires suppliers to proceed with the conformity assessment procedure through Ukrainian TRs even if a manufacturer already owns a CE Certificate.
But there is an option to recognize the certificate issued by the European Notified Body. This is a very convenient and straightforward process for medical device suppliers who have already certified their medical devices in the EU.
The recognition of the CE Certificate is acquired through mutual recognition by the notified national bodies based on the agreement.
For the recognition of the conformity assessment results carried out by a foreign body, the following conditions must be satisfied:
- The Ukrainian designated conformity assessment body must have a signed agreement on the recognition of the conformity assessment results with a foreign notified body;
- The foreign CAB must have a proper accreditation;
- The manufacturer must file an application for the recognition procedure along with all necessary technical documentation to the Ukrainian CAB.
Since the recognition procedure allows manufacturers to avoid on-site manufacturer audits, the process of conformity assessment is significantly simplified, speeded up, and cheapened.
Be aware that the expiry date of Ukrainian Certificate is the same as the one of the CE Certificate.
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