On February 10^th 2016, the Law of Ukraine “On Technical Regulations and Conformity Assessment” came into force, article 45 of which describes the possibility of recognizing the results of conformity assessment performed in another country. There are several options for recognition, and with respect to each of the options, the Law sets forth the appropriate conditions.

Since Technical Regulations on medical devices are based on the relevant EU Directives, paragraph 1 of Article 45 of this Law regarding the provision of conformity assessment procedures by the applicable procedures for assessing compliance with the same level of compliance with the requirements is fulfilled:

The second paragraph of Article 45 describes that for international recognition of documents (that is, the recognition of certificates, protocols, reports etc.), an international agreement on mutual recognition of conformity assessment results between Ukraine and another country is required. There are currently no such agreements in the field of medical devices, and in the long term mutual recognition of the results with the EU is possible by signing the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) regarding medical devices, which is one of the components of the Association Agreement between Ukraine and the European Union.

The third paragraph of the article describes the possibility of conformity assessment results recognition by the national designated bodies under its own responsibility, on the basis of signed recognition agreements with foreign accredited conformity assessment bodies (subject to the same requirements for accreditation), and in consequence the possibility of carrying out the national procedure or its part.

Therefore, to recognize the results of conformity assessment, the following conditions must be met:

• The Ukrainian designated conformity assessment body has a signed Agreement on the recognition of the conformity assessment results with a foreign notified body;
• The foreign notified body has proper accreditation;
• The foreign notified body has an appointment for the relevant Directives;
• An application for the recognition procedure and a necessary dossier of documents was submitted to the Ukrainian designated body.

The Ukrainian Scientific Institute of Certification has concluded, and continues to conclude, agreements on the recognition of the conformity assessment results with leading European notified bodies.

If your EU certificate is issued by one of these notified bodies, we can conduct conformity assessment procedure through recognition of the EU conformity assessment results, that will allow you to facilitate and speed up the initial procedure, annual surveillance and extension of the certificate scope (adding new products, sites). We have the best knowledge and experience in Ukraine for carrying out such a procedure and we are also examining documents in English and German.

We will be happy to answer all your questions! You can contact us on the contact page