All medical devices are subject to the assessment of conformity to the following Technical Regulations:
– Technical Regulation on Medical Devices, approved by Resolution No. 753 issued by the Cabinet of Ministers of Ukraine on October 02, 2013
– Technical Regulation on Medical Devices for In Vitro Diagnostics, approved by Resolution No. 754 issued by the Cabinet of Ministers of Ukraine on October 02, 2013
– Technical Regulation on Active Implantable Medical Devices, approved by Resolution No. 755 issued by the Cabinet of Ministers of Ukraine on October 02, 2013

Depending on the class of medical devices the assessment of conformity either may involve an authorized body or may not involve it, in which case the self-declaration process is carried out.
Conformity of the below medical devices may be assessed without involving a conformity assessment body:
– class I devices (non-sterile, without a measuring function) per Technical Regulation on Medical Devices (Resolution No. 753 issued by the CMU)
– analyzers, reagents, calibration and monitoring units that are not mentioned in Lists A and B of the Technical Regulation on Medical Devices for In Vitro Diagnostics (Resolution No. 754 issued by the CMU) and are not intended for self-monitoring purposes.
To assess the conformity of all other medical devices to Technical Regulations, that are listed below, a conformity assessment body must be involved:
• class I medical devices (sterile), class I devices with a measuring function, class IIa, IIb or III, according to the Technical Regulation on Medical Devices (Resolution No. 753 issued by the CMU);
• reagents, calibration and monitoring units mentioned in lists A and B of the Technical Regulation on Medical Devices for In Vitro Diagnostics (Resolution No. 754 issued by the CMU) and self-monitoring devices
• All medical devices that fall within the scope of the Technical Regulation on Active Implantable Medical Devices (Resolution No. 755 issued by the CMU).
All procedures that require the involvement of a conformity assessment body may apply to:
– one shipment. This option allows to avoid arranging the inspection of the manufacturing site, since experts will review the documents and test product samples where the documents were filed. In this case the assessment will yield a Conformity Assessment Certificate applicable only to one shipment of medical devices. Warning! This procedure is not appropriate for sterile products!
– serial manufacturing. This option involves not only the document review part but also the inspectors’ visit to the factory. In this case the assessment will yield a Conformity Assessment Certificate applicable to all products that have been assessed and are manufactured within the term of the certificate which is 5 years. However, during the term of the Certificate auditors shall at least once a year visit the site where medical devices are manufactured.

The manufacturer’s authorized representative shall be regarded by national bodies (specializing in the assessment of conformity, market surveillance, income and charges, etc.) as the manufacturer’s integral part and be a functional component of its core activity within Ukraine. Any questions about the safety and quality of products shall be forwarded to the Authorized Representative who shall also keep all documents on the assessment of conformity for at least 5 years (or 15 years for implantable medical devices) and provide the same upon appropriate request.
The Authorized Representative’s primary activity is to represent foreign manufacturers within Ukraine and arrange communication between the foreign manufacturer of medical devices and the Ukrainian market.
The Authorized Representative shall operate in Ukraine under the Power of Attorney and/or the Agreement he/she/it made with the manufacturer. The agreement would be the best option to set forth the parties’ rights and obligations, cover the liability of the authorized representative and manufacturer regarding quality and safety, timeframes and procedure of communication exchange, management of claims and messages about adverse events and many other aspects, such as post-marketing surveillance and proper custody and provision of documents upon request.
The information, including the name and location of the authorized representative, shall be available both on the packaging of each medical device and/or in the IFU. Moreover, each medical device (type/model) shall be linked to one authorized representative only.
If for some reason the manufacturer does not have a partner in Ukraine whom it can appoint as its Authorized Representative, then we can handle those operations and obligations.

The self-declaring process requires to obtain the power of attorney for being the manufacturer’s authorized representative in Ukraine and prepare the Technical File which according to the Technical Regulation shall include:
• the general description of a medical device including all modifications scheduled for that device as well as its intended use
• design drawings
• information about the methods prescribed for manufacturing of the specified medical device, as well as the diagrams of components, units, circuits, etc.
• description and legend required to understand what the said drawings and diagrams mean and how the medical device operates
• risk analysis findings
• information about standards that apply in full or in part and are listed among the ones that meet the European harmonized standards and, when applied voluntarily, can be regarded as evidence showing medical devices’ conformity to the Technical File on Medical Devices, as well as the description of decisions made for the purpose of compliance with the Technical Regulation on Medical Devices if the said standards apply in part
• findings of design-related calculations and reviews
• confirmation of conformity to the Technical Regulation’s requirements that govern medical devices only if they are to be connected to other ones; if the medical device is supposed to be connected to other medical devices for the purpose of intended use
• preclinical assessment findings
• clinical assessment findings
• the label and IFU

We offer the following self-declaration-related services:

• We prepare the list of the documents required by the respective Technical Regulation.
• We handle the appraisal of documents.
• We prepare the Technical File that is based on the Technical Regulation.
• We translate the required documents.
• We prepare the Declaration of Conformity to Technical Regulations.
• We submit the required set of documents for the State Drugs and Medications Control Service to add the details to the register of people responsible for commercialization of medical devices.

To pass this procedure we offer the following services:
• We arrange undergoing the conformity assessment as approved by authorized bodies via Technical Regulations.
• We translate the required documents.
• We prepare the Technical File in accordance with the respective Technical Regulation.
• We select the conformity assessment body, submit the documents, pay the authorized body for doing its job, pass the document appraisal, respond to remarks, discuss what facilities on what days and under what schedule will be inspected.
• We arrange the inspectors’ visits to the manufacturing site.
• We develop the labeling design.
• We prepare the Declaration of Conformity to the Technical Regulations.