Conformity assessment of medical devices

Since 1 July 2015, it has been a mandatory requirement that medical devices, before being placed on the Ukrainian market and/or put into service, must be subject to the assessment of conformity with the Technical regulations (TR) (approved by Resolutions No. 753, 754, 755 of the CMU of 2 October 2013).

Clause 21 of Resolution No. 753 of the CMU of 2 October 2013 allows medical devices with valid registration certificates to be placed on the market and/or put into service until 1 July 2016, without undergoing the conformity assessment procedures and being affixed with the national conformity mark.

The medical devices placed on the market and put into service in accordance with this regulation may be sold and used in Ukraine until their expiration date, without undergoing the conformity assessment procedures or being affixed with the national conformity mark. The Ukrainian Scientific Institute of Certification has been designated to carry out the procedures for assessment of conformity with the Technical regulation on medical devices and the Technical regulation on in vitro diagnostic medical devices.

According to Annex 2 to the Technical regulation, medical devices are divided into classes I, Im, Is, IIa, IIb, and III.

In vitro diagnostic devices are classified as List A, List B, devices for self-testing, etc.

The classification of the medical device defines the route of the assessment of the conformity with the applicable technical regulation. The choice of the conformity assessment route should be guided by the following:

Procedures for conformity assessment set out in the Technical regulation on medical devices as approved by Resolution No. 753 of the CMU dated 2 October 2013, or

Procedures for conformity assessment set out in the Technical regulation on in vitro diagnostic medical devices as approved by Resolution No. 754 of the CMU dated 2 October 2013.

The procedure for conformity assessment, from the submission of an application and up to the issuance of a certificate, is described below:

Conformity assessment procedure.

In order to facilitate the understanding between the notified body and the applicants, we decided to carry out the tasks pertaining to conformity assessment in line with the European Commission Guidance MEDDEVs.

The Uni-CERT specialists will help you to complete the application, choose the proper procedure for conformity assessment, and to understand all the aspects of the legislation applicable to the necessary tasks.

Please be informed that the notified body will be able to prepare a quotation, determine the number of the audit days and what sites should be inspected only after it has been provided with a completed draft application.

Once the applicant has lodged a signed application with a notified body, he may not lodge a similar application with any other notified body.

Application form  (download)

We would be happy to answer your questions, please contact us.

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