1. Our company can help you obtain EU certificate recognition and provide project support from the initial correspondence to the receipt of the certificate. Our team of experts can communicate with you in Ukrainian, Russian, or English to ensure clear and professional communication.
2. Our services include the development of all necessary documents for the Ukrainian market, translation of documents, and assistance in selecting a conformity assessment body.
3. We will manage the submission of documents and support the expert evaluation process. Our team will monitor the timeline and assist in resolving any inconsistencies identified by the conformity assessment body. We can also expedite the conformity assessment process to help you obtain your certificate quickly and with minimal effort.
IF YOU HAVE ANY QUESTIONS, THE COMPANY’S EXPERTS WILL PROVIDE FREE CONSULTATIONS
Recognition of a certificate issued in the EU is one of the ways to verify the conformity of medical devices in Ukraine. The conformity assessment body in Ukraine considers the results of the conformity assessment (MDD/MDR certificates) and the relevant documents submitted with the certificate, known as “recognition”. If the results are positive, the body will issue a certificate for those medical devices (scope) that are specified in the manufacturer’s certificate and for the validity period for which the CE certificate was issued. After receiving such a certificate, annual surveillance and recertification are carried out.
The most important advantage of the recognition procedure is the ability to avoid audits at the production site of the respective medical device manufacturer. Recognition of the results of the work of the European body allows for quick and cost-effective certification of EU-approved medical devices.
The procedure for recognition of a certificate issued in the EU can be applied to medical devices of all classes, including high-risk classes III and IV, provided that such devices have the appropriate certificates from European notified bodies and meet the requirements of the European Medical Device Directives (MDD/MDR).
Recognition of the EU certificate is a rather complicated procedure and requires fulfillment of a number of requirements to be able to manufacture, import and introduce medical devices in Ukraine.
First, a non-resident manufacturer must appoint an Authorized Representative in Ukraine to represent its interests. To begin the procedure, it is necessary to collect the technical documentation specified in the Annex to the Technical Regulations and execute it.
Depending on the requirements of a particular certification body, the documents may be translated into Ukrainian. The application for certification, labeling, instruction (user manual), checklist of basic requirements (Annex 1 to the Technical Regulations), draft Declaration of Conformity, cover letters, and other national documents are also developed.
Next, the Application and the relevant documentation are submitted to the Ukrainian certification body, which evaluates the documentation. In the process, the Ukrainian body requires the submission of protocols, reports, and letters from the European body that issued the EU certificate. The manufacturer or the Ukrainian party must fulfill many additional requirements, including the preparation of letter templates and filling out forms.
If the Ukrainian authority recognizes the EU certificate as compliant, it will issue a Certificate of Conformity.
