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.

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Example certificate

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:

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.

We also offer work on conformity assessment in the following areas:

Technical regulations of personal protective means No. 761 of the CMU of 27.08.2008

Technical regulation of low-voltage electrical equipment, Resolution No. 1067 of the CMU of 16.10.2015

Technical regulations on electromagnetic compatibility of equipment, Resolution No. 1077 of the CMU of 16.10.2015

Technical regulations for the restriction of the use of certain hazardous substances in electrical and electronic equipment, Resolution No. 139 of the CMU of 10.03.2017

Conformity assessment in these areas can be carried out on a voluntary basis – to gain competitive advantage.

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.