HEALTHCARE AND MEDICAL DEVICES E-SSENTIALS

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TÜV SÜD supports medical device registration in Ukraine 

Ukraine has introduced as effective and binding of July 1, 2015, the registration of medical devices according to new national regulations that are identical to the European directives for medical devices. After an initial transition period of one year, the Government of Ukraine has extended the period by one year until July 1, 2017. Against this background TÜV SÜD offers collaboration to Ukrainian Notified Bodies with the intent to allow certification of medical devices based on a valid certification performed by TÜV SÜD.

Ukraine has adopted the European regulatory framework for medical devices as well as for in-vitro diagnostics and active implantable devices, transformed it into national regulations, and issued a new national conformity mark. After July 1, 2017, all products requiring a first or renewed certification have to comply with the new regulations. Products certified according to the former national regulations are still allowed until the expiry date of their certificate, but no longer than five years from the date of their placing on the market.

To bring new registrations forward, Ukrainian Notified Bodies can initiate an agreement with TÜV SÜD that allows them to recognize the results of TÜV SÜD conformity assessments according to the European directives. These results will then be the basis for Ukrainian Notified Bodies to issue conformity certificates for the Ukrainian market access. This makes registration much faster and easier, most of all it avoids additional audits of the medical device manufacturers to be performed by the Ukrainian Notified Bodies. TÜV SÜD has already signed the first agreement with an Ukrainian Notified Body and is ready to sign similar agreements with other Ukrainian Notified Bodies. Manufacturers applying for a new registration in Ukraine are advised to invite their local Notified Bodies to contact TÜV SÜD on such collaboration.

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