The Ukrainian Scientific Institute of Certification is a designated conformity assessment body that cooperates with bodies entrusted with similar functions in the EU – notified bodies. Cooperation allows for the exchange of experience, which brings the implementation of work practices in Ukraine closer to the EU, and also – on the basis of Article 45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” and concluded agreements on the recognition of conformity assessment results – to recognize in Ukraine the conformity assessment work of European notified bodies.

Due to the increase of the quantity input of requests on the procedure of the recognition of European Notified Bodies conformity assessment results in relation to medical devices, we inform that at the moment Ukrainian Scientific Institute of Certification has signed the agreements on recognition of conformity assessment results with:

1.  TÜV SUD Product Service GmbH (0123)

2.  TÜV Rheinland LGA Products GmbH (0197)

3.  TÜV NORD Polska Sp. z o.o (2274)

4.  TÜV NORD CERT GmbH (0044)

5.  BSI Group The Netherlands B.V. (2797)

6.  DEKRA Certification B.V. (0344)

7.  DEKRA Certification GmbH (0124)

8.  DQS Medizinprodukte GmbH (0297)

9. ITALCERT S.r.l. (0426)

10. Kiwa Cermet Italia S.p.a. (0476)

11. Kiwa Belgelendirme Hizmetleri A.Ş. (1984)

12. Lloyd’s Register Quality Assurance (LRQA) (0088)

13. Eurofins product testing Italy s.r.l (0477)

14. Intertek Medical Notified Body AB (2862)

15. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (0318)

16. Elektrotechnický zkušební ústav, s.p. (EZÚ) (1014)

17. GMED (0459)

18. SLG Prüf – und Zertifizierungs GmbH (0494)

19. Bureau Veritas Italia S.P.A. (1370)

20. Presafe Denmark A/S (0543)

21. Szutest Uygunluk Değerlendirme A.Ş. (2195)

22. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (0051)

23. UL INTERNATIONAL (UK) LTD (0843)

24. RISE Research Institutes of Sweden AB (0402)

25. ICIM S.p.A. (0425)

26. CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. (2409)

27. MDC Medical Device Certification GmbH (0483)

28. Polish Centre for Testing and Certification (1434)

29. DNV Product Assurance AS (2460)

30. Ente Certificazione Macchine S.r.l (1282)

31. SGS Belgium NV (1639)

32. UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi San. ve Tic. A.Ş. (2292)

33. The European laboratory CENTEXBEL, accredited by BELAC for compliance with the requirements of EN ISO / IEC 17025 for testing various products.

34. The Turkish laboratory Ekoteks Laboratuvar ve Gözetim Hizmetleri. Ekoteks Laboratory is accredited according to the standart of ISO/IEC 17025 with the number of AB-0583-T by TURKAK (Turkish Accreditation Agency), an independent certification body which is a member of international laboratory accreditation committee ILAC.

Conceive that such procedure significantly reduces the time and financial expenses of our customers on certification of their products in Ukraine, we will be grateful for any information assistance for concluding agreements with other European notified bodies and laboratories.

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