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.<\/p>\n
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\u00a0Ukrainian Scientific Institute of Certification has signed the agreements on recognition of conformity assessment results with:<\/p>\n
1.\u00a0\u00a0T\u00dcV SUD Product Service GmbH<\/a>\u00a0(0123)<\/p>\n 2.\u00a0\u00a0T\u00dcV Rheinland LGA Products GmbH<\/a>\u00a0(0197)<\/p>\n 3.\u00a0\u00a0T\u00dcV NORD Polska\u00a0Sp. z o.o<\/a>\u00a0(2274)<\/p>\n 4.\u00a0\u00a0T\u00dcV NORD CERT GmbH<\/a>\u00a0(0044)<\/p>\n 5.\u00a0 BSI Group The Netherlands B.V.<\/a>\u00a0(2797)<\/p>\n 6.\u00a0 DEKRA Certification B.V.<\/a>\u00a0(0344)<\/p>\n 7.\u00a0 DEKRA Certification GmbH<\/a>\u00a0(0124)<\/p>\n 8.\u00a0 DQS Medizinprodukte GmbH<\/a>\u00a0(0297)<\/p>\n 9. ITALCERT S.r.l.<\/a>\u00a0(0426)<\/p>\n 10. Kiwa Cermet Italia S.p.a.<\/a>\u00a0(0476)<\/p>\n 11. Kiwa Belgelendirme Hizmetleri A.\u015e.<\/a>\u00a0(1984)<\/p>\n 12. Kiwa Assurance B.V.<\/a> (1912)<\/p>\n 13. Lloyd\u2019s Register Quality Assurance (LRQA)<\/a>\u00a0(0088)<\/p>\n 14. Eurofins product testing Italy s.r.l<\/a>\u00a0(0477)<\/p>\n 15. Intertek Medical Notified Body AB<\/a> (2862)<\/p>\n 16. Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (AEMPS)<\/a>\u00a0(0318)<\/p>\n 17. Elektrotechnick\u00fd zku\u0161ebn\u00ed \u00fastav, s.p. (EZ\u00da)<\/a>\u00a0(1014)<\/p>\n 18. GMED<\/a>\u00a0(0459)<\/p>\n 19. SLG Pr\u00fcf \u2013 und Zertifizierungs GmbH<\/a>\u00a0(0494)<\/p>\n 20. Bureau Veritas Italia S.P.A.<\/a>\u00a0(1370)<\/p>\n 21. Presafe Denmark A\/S<\/a>\u00a0(0543)<\/p>\n 22. Szutest Uygunluk De\u011ferlendirme A.\u015e.<\/a>\u00a0(2195)<\/p>\n 23. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALIT\u00c0 S.P.A.<\/a>\u00a0(0051)<\/p>\n 24. UL INTERNATIONAL (UK) LTD<\/a>\u00a0(0843)<\/p>\n 25. RISE Research Institutes of Sweden AB<\/a>\u00a0(0402)<\/p>\n 26. ICIM S.p.A.<\/a>\u00a0(0425)<\/p>\n 27. CE Certiso Orvos- \u00e9s K\u00f3rh\u00e1ztechnikai Ellen\u0151rz\u0151 \u00e9s Tan\u00fas\u00edt\u00f3 Kft.<\/a>\u00a0<\/strong>(2409)<\/p>\n 28. MDC Medical Device Certification GmbH<\/a>\u00a0(0483)<\/p>\n 29. Polish Centre for Testing and Certification<\/a>\u00a0(1434)<\/p>\n 30. DNV Product Assurance AS<\/a>\u00a0(2460)<\/p>\n 31. DNV MEDCERT GmbH<\/a> (0482)<\/p>\n 32. Ente Certificazione Macchine S.r.l<\/a>\u00a0(1282)<\/p>\n 33. SGS Belgium NV<\/a> (1639)<\/p>\n 34. UDEM Uluslararas\u0131 Belgelendirme Denetim Eg\u0306itim Merkezi San. ve Tic. A.S\u0327.<\/a> (2292)<\/p>\n 35. The European laboratory CENTEXBEL<\/a>, accredited by\u00a0BELAC<\/a>\u00a0for compliance with the requirements of\u00a0EN ISO \/ IEC 17025<\/a> for testing various products.<\/p>\n 36. The Turkish laboratory Ekoteks Laboratuvar ve G\u00f6zetim Hizmetleri<\/a>. Ekoteks Laboratory is accredited according to the standart of ISO\/IEC 17025 with the number of AB-0583-T by TURKAK<\/a> (Turkish Accreditation Agency), an independent certification body which is a member of international laboratory accreditation committee ILAC<\/a>.<\/p>\n 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.<\/p>\n