The designated Certification and conformity assessment body IMPROVE MEDICAL actually signs agreements with all top European Notified Bodies on the recognition of the conformity assessment results that are accredited and approved in accordance with relevant EU Directives (see list below). Notified Bodies work in all countries of the European Union, its partner countries and in many countries of the world.
Improve Medical continues preprocessing of the signing contracts with other top European Notified Bodies.
These agreements allow for Improve Medical customers the opportunity to reduce technical barriers in the process of medical devices legalization in Ukraine for compliance with the technical regulations.
The signing of recognition agreements is regulated by art.45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”. In particular, Ukrainian conformity assessment body, on the basis of a document of compliance issued by a foreign notified body, applies the conformity assessment procedure or a part of it, and issues Ukrainian Certificate of conformity on its own responsibility.
In other words, depending on the specific situation and the class of the medical product, Improve Medical can apply the recognition procedure of conformity assessment results already performed by foreign accredited bodies.
But, it should be kept in mind that the legislation does not specify a list of cases (when the whole procedure or a part of it is applied), nor references to bylaws. While the procedure of recognition of the results of conformity assessment carried out outside Ukraine is not regulated in the Technical Regulations.
Subject to the specified Art.45 of the mentioned Law, the documents on compliance are recognized in accordance with the rules determined by the signatories of recognizing agreement – Ukrainian and foreign conformity assessment bodies. The Conformity Assessment Body Improve Medical is ready to take responsibility under the signed agreements, and the competence of the company’s specialists allows for the correct verification of results of the medical products conformity assessment performed by Notified Bodies for their legalization in Ukraine.
European Notified Bodies with which Improve Medical has signed agreements on the recognition of results of medical products conformity assessment:
- ITALCERT S.r.l. NB 0426
- TÜV SÜD Product Service GmbH Zertifizierstellen NB 0123 (Германия)
- MEDCERT NB 0482
- TÜV Rheinland NB 0197
- NATIONAL EVALUATION CENTER OF QUALITY & TECHNOLOGY IN HEALTH SA – EKAPTY SA NB 0653
- SIQ – Slovenian Institute of Quality and Metrology NB 1304 (Словения)
- SZUTEST NB 2195
- BSI NB 0086
- DNV GL Presafe AS NB 2460
- LRQA NB 0088
- IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. NB 0051 (Италия)
- KIWA CERMET ITALIA S.P.A. NB 0476
- MDC medical device certification NB 0483
- DQS NB 0297
- SLG Prüf- und Zertifizierungs GmbH NB 0494)
- TUV NORD CERT GmbH NB 0044
- AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS NB 0318
- DEKRA NB 0344
- Eurofins Expert Services Oy NB 0537
- BSI Group The Netherlands B.V. NB 2797
- Kiwa Belgelendirme Hizmetleri A.Ş. NB 1984
- TUV NORD Polska Sp. z o.o NB 2274
- DEKRA Certification B.V. NB 0344
- BUREAU Veritas NB 1370
- Eurofins Product Testing Italy S.r.l. NB 0477
- CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. NB 2409
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