Documents required for legal placement of medical devices on the market. Market surveillance.

PROGRAM

Temporary changes in the rules of import of medical devices and personal protective equipment needed to prevent the COVID-19
Conformity assessment procedures: self-declaration or assessment with the involvement of a designated body
Requirements for accompanying documentation: labeling, instructions for use, declaration of conformity
Application of the requirements of the Law of Ukraine “On ensuring the functioning of the Ukrainian language as the state language” and the Order of the Ministry of Economic Development dated 04.08.2015 No. 914
Basic principles for conducting market surveillance and control of medical devices. Main types of nonconformities

Nikolay Matlaev, The lead auditor on certification of quality management systems and conformity assessment with technical regulations of the “Ukrainian Scientific Institute of Certification”

Share this:

Other news

29.08.2022

The 11th Ukrainian forum of medical device market operators was held

On August 26, the 11th anniversary Ukrainian forum of medical device market operators took place, which provided manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience during martial law. Ukrainian Scientific Institute of Certification was traditionally a partner of this event. In addition, Victoria Shevchenko, Head […]

26.08.2021

Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices

PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]

09.01.2023

Public health: more time to certify medical devices to mitigate risks of shortages

On January 6, 2023 the European Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices’ risk class and will […]