About the project

Most medical devices are accompanied by instructions necessary for their safe use. If the instructions are mandatory or provided by the manufacturer, they must be supplied with each product.

Thus, the medical device industry generates a large number of paper instructions, some of which may be redundant for the end-user, for example, in the case of regular deliveries of the same products to a hospital or laboratory. At the same time, it harms the environment and increases the final cost of the product.

In today's world, paper information has become archaic - it is inconvenient to store, finding the right data takes time, access may be limited, and it is impossible to update the printed text.

This project provides an opportunity for manufacturers of some medical devices to switch from paper to electronic instructions, and for users to receive a free paper version if necessary.

We expect that our project will allow:

  • reduce the burden on the environment;
  • increase the overall safety of medical devices;
  • improve access to safety information and allow its updating;
  • reduce the cost for the consumer by reducing costs of production;
  • simplify the processes of labeling and marketing of products;
  • improve regulatory compliance.

This project is developed according to the requirements of GHTF/SG1/N70:2011 and international approach, the responses of the Ministry of Health of Ukraine and the State Service of Ukraine for Medicines and Drug Control regarding the use of electronic instructions.

We are open to cooperation with manufacturers of medical devices and their Authorized Representatives in Ukraine, as well as with any interested organizations and individuals.

This project is commercial. We provide the necessary consulting, develop and implement necessary actions for the transition to electronic instructions, conduct or assist with the legal and regulatory issues.

The administrator of the project is LLC "Cratia Medtekhnika", address st. Baggovutovskaya 17-21, 6th floor, Kyiv, 04107, Ukraine. You can contact us by e-mail info@uarep.com or by phone +38 (044) 221-71-29.