The designated Conformity Assessment Body Improve Medical (Ukraine) concluded the agreement on recognition of medical devices conformity assessment results with the European notified body – the company MEDCERT headquartered in Hamburg (Germany) and having offices in the USA, China and Malaysia. The company is accredited and approved in accordance with the relevant EU Directives
In total, Improve Medical concluded cooperation agreements with 11 largest Notified Bodies of Europe (see list below).
The above agreements enable the clients of Improve Medical to reduce technical barriers during legalization of medical devices in Ukraine for compliance with the Technical Regulations.
Depending on the specific situation and class of medical device, we can apply the procedure for recognition of the results of conformity assessment, which had been already conducted by the foreign accredited bodies.
Improve Medical is ready to take responsibility within the frameworks of the agreements concluded, and the competence of the company’s specialists ensures correct verification of the medical devices assessment results by the Notified Bodies for their legalization in Ukraine.
Should you have any questions, please contact us by phone +38 0443555030 or e-mail email@example.com – Elena Goy
The experts of Improve Medical will always inform you about application of the Ukrainian legislation in the field of technical regulation.
The Notified Bodies in Europe with which Improve Medical signed agreements on recognition of medical devices conformity assessment results:
1. ITALCERT S.r.l. (Италия)
2. TÜV SÜD Product Service GmbH Zertifizierstellen (Германия)
3. MEDCERT (Германия)
4. TÜV Rheinland (Германия)
5. NATIONAL EVALUATION CENTER OF QUALITY & TECHNOLOGY IN HEALTH SA – EKAPTY SA (Греция)
6. SIQ – Slovenian Institute of Quality and Metrology (Словения)
7. SZUTEST (Турция)
8. BSI. (Великобритания)
9. Udemadriatic (Хорватия)
10. LRQA (Великобритания)
11. IMQ (Италия)
12. KIWA (Holland)
13. MEDCERT medical device certification