On February 10th 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:
|Technical regulation on medical devices, approved by Decree of Cabinet of Ministers of Ukraine №753 on 2 October 2013||Council Directive 93/42/EEC of 14 June 1993 concerning medical devices|
|Technical regulation on medical devices for in vitro diagnostic, approved by Decree of Cabinet of Ministers of Ukraine №754 on 2 October 2013||Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices|
|Technical regulation on active implantable medical devices, approved by Decree of Cabinet of Ministers of Ukraine №753 on 2 October 2013||Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices|
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 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.
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