Under art.45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, results of the conformity assessment to the technical regulations requirements, conducted in another state, are accepted and recognized in Ukraine, if the conformity assessment procedures, used in this state (even if they differ from the Ukrainian procedures), provide the same level of compliance with the requirements of the relevant technical regulations as the Ukrainian conformity assessment procedures.
Conformity assessment bodies have the right to recognize the results of conformity assessment to the requirements of technical regulations conducted by foreign accredited conformity assessment bodies, on the basis of agreements with such conformity assessment bodies, provided that:
- national accreditation bodies to accredit conformity assessment bodies both in Ukraine and in another state, are members of an international or regional accreditation organization and / or have entered into an agreement on mutual recognition with such an organization regarding relevant types of conformity assessment activities;
- on the basis of a Certificate of conformity issued by a foreign conformity assessment body, the designated body applies a conformity assessment procedure or a part of it, and issues a conformity Certificate provided for by this procedure on its own responsibility.
The designated Conformity Assessment Body IMPROVE MEDICAL UA.TR.120 systematically pushes back the limits in collaboration with international conformity assessment bodies. In the portfolio of IMPROVE MEDICAL, there are already more than 20 signed agreements on recognition of results of the medical products conformity assessment.
Do you hold the CE-mark Certificate for medical products that you are going to bring to the Ukrainian market?
Do you have technical documents, clinical assessment materials and audit reports confirming the conformity of the medical device to international standards?
Find out which Ukrainian CA bodies can recognize the assessment results of notified EU bodies; and also when it makes sense for the supplier to choose a procedure for confirming conformity assessment, and when – to pass it in Ukraine for compliance with Ukrainian technical regulations.
The Information Services Centre of the designated Conformity Assessment Body IMPROVE MEDICAL UA.TR.120 invites the medical products market operators to a charge-free Webinar concerning the recognition of results of the medical devices conformity assessment performed in the EU.
The Webinar will take place on May 16, Thursday, at 11.00 am (Kyiv time – UTC+2).
Duration of the Webinar: 2 hours.
Language of the webinar: Ukrainian/Russian
Conditions of participation: the event is charge-free.
ORDER OF THE DAY:
- When is it possible to recognize the results of the assessment performed by a notified body of the EU by a Ukrainian authority?
- What is the recognition mechanism for the results of the medical devices conformity assessment performed in the EU countries, and what are its stages?
- Are there “pitfalls” in the case of CA by recognizing a CE-mark Certificate regarding a market operator?
- What documents should be submitted to the Ukrainian conformity assessment body to have it take into account the results of the conformity assessment of foreign colleagues?
- On the practical experience of the IMPROVE MEDICAL in conducting conformity assessment by recognizing the CE-mark Certificate.
- What are the basic requirements to be taken into account by the supplier of the medical devices during supervising audits in case of a CA by recognizing the CE-mark Certificate?
The sign up in reserve is compulsory at link.
Contact person: Galina Goy, Auditor of the Conformity Assessment Body IMPROVE MEDICAL, +38 044 355 50 30, firstname.lastname@example.org
Don’t fail to come – we look forward to seeing you!