|Since July 1, 2017, all medical devices imported and put into circulation must meet the requirements of all applicable Technical Regulations. Symbol of conformity to Technical regulations must be affixed on each individual medical device prior to placing on the market.||
The main legislative acts are the Law of Ukraine “On Technical Regulations and Conformity Assessment” and three specialized technical regulations:
- Technical regulations for medical devices, approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013;
- Technical regulations for medical devices for in-vitro diagnostics, approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated October 2, 2013;
- Technical regulations for active implantable medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 755 dated October 2, 2013.
The central executive body that ensures the formation of state policy in the field of technical regulation is the Ministry for Development of Economy, Trade and Agriculture of Ukraine. The central executive authority that performs the functions of technical regulation of medical devices is the Ministry of Health of Ukraine. The body of state market surveillance is the State Service of Ukraine on Medicines and Drugs Control.
Technical regulations for medical devices are based on EU Directives, and overall technical regulation in Ukraine is based on a model similar to the EU. Documentation requirements and procedures will be familiar to manufacturers who have passed conformity assessment and placed medical devices on the EU market.
Nevertheless, there are a large number of national features in Ukraine, including:
- designation of an Authorized Representative, that must be a resident of Ukraine, is required;
- conformity assessment procedures imply the involvement of national conformity assessment bodies and/or registration with a competent authority;
- labeling and instructions are made in Ukrainian language;
- before placing products on the market, it is necessary to affix a symbol of conformity to technical regulations etc.
A non-resident manufacturer must designate an Authorized Representative in Ukraine. An Authorized Representative may be a resident of Ukraine, a legal entity or an individual. The name and address of the Authorized Representative must be indicated on the labeling or in the instructions for use for each individual medical device.
The designation of an Authorized Representative should be in writing. To do this, we recommend using both the Power of Attorney and the Agreement: as the Power of Attorney is convenient for granting to third parties (for example, for customs clearance, for participation in tenders, etc.), and the Agreement describes not only the transferred rights, but also the obligations of each party.
An Authorized Representative acts as a link between the Ukrainian market (distributors and consumers, conformity assessment bodies, market surveillance authorities, law enforcement and other authorities) and a non-resident manufacturer, and also bears primary responsibility for the quality and safety of medical devices in circulation in Ukraine. An Authorized Representative must keep the documentation (certificate and declaration of conformity, Technical File, labeling, instructions and other documents) for at least 5 years.
The legislation determines that a manufacturer may designate only one Authorized Representative for each medical device, but does not restrict the manufacturer from designation of different representatives for different medical devices.
The Authorized Representative may be either the importer (distributor) or marketing organization, or a third party not related to the supply chain.
Cratia Medtekhnika LLC provides professional Authorized representative services for the medical devices industry. We are ISO 9001 certified highly experienced team, independent from the supply chain, strictly compliant to the national legislation. We facilitate and defend your business, have excellent relations with competent authorities and membership in business associations.
For more information please visit our website http://uarep.com/.
Conformity assessment bodies (notified bodies) for medical devices
The conformity assessment of medical devices (with the exception of class I products that are not sterile and have not a measurement function, and the “other” group products for in-vitro diagnostic) is performed by the conformity assessment bodies authorities. In Europe such organizations are called “notified bodies”, but for Ukraine the term “conformity assessment body” is more accurate.
Conformity assessment bodies can be either state-owned or private. The bodies are accredited by the National Accreditation Agency of Ukraine for ISO /IEC 17021, ISO/IEC 17025 and ISO/IEC 17065 standards, supervised by the Ministry of Health and receive the designation (similar to “notification”) of the Ministry for Development of Economy, Trade and Agriculture of Ukraine to perform conformity assessment for the relevant Technical Regulations. A list of designated conformity assessment bodies is published by the Ministry for Development of Economy, Trade and Agriculture of Ukraine.
The Conformity assessment body is chosen by the manufacturer or his Authorized Representative, and the identifier code of the body must be indicated near the symbol of conformity to technical regulations.
Despite the unified requirements for accreditation, the authorities significantly vary in approach to pricing, in the current workload and the timing of the work, in the quantity and competence of staff, in language skills, in technical capabilities and many other issues. Taken together, such nuances are critical since they have a significant impact on the cost, duration and many other aspects of the initial conformity assessment procedure and its annual maintenance.
Device classification and conformity assessment procedures
The class and characteristics of the medical device determine the conformity assessment route and the necessity to involve the designated body. The higher the class, the greater the risk, and the more complicated the certification procedure is:
|Device class and characteristics:||Applicable conformity assessment routes:|
|Class I medical devices;
Devices for in-vitro diagnostics, group “other”;
|Conformity assessment body is not involved. Manufacturer or it’s Authorized representative performs the “Internal quality control” procedure, fills in the Technical file and national forms, issues the Declaration of conformity and apply for registration at the competent authority.|
|In-vitro diagnostics medical devices for self-control;||Design verification certificate issued by conformity assessment body is combined with “Internal quality control” procedure. Declaration of conformity should be registered at the competent authority.|
|Non-sterile devices of classes Im, IIa, IIb; Medical devices for in-vitro diagnostics List “B” and intended for self-monitoring;||There is a choice between (1) classical procedure with audit, (2) partial EC certificate recognition or (3) batch certification procedure. Relevant Application should be submitted to the conformity assessment body.|
|Sterile medical devices, class III medical devices;
Devices for in-vitro diagnostics from List “A”;
Active implantable medical devices;
|There is a choice between (1) classical procedure with audit or (2) partial EC certificate recognition. Relevant Application should be submitted to the conformity assessment body.
Design examination certificate is required for class III devices.
NB! Registration of the person responsible for placing of the medical devices on the market is mandatory for all devices of class I, including Im and Is, as well as for all in-vitro diagnostics medical devices.
The “self-declaration” procedure (internal quality control) is applied only to the safest products, which include about 30% of all medical devices, and more than 80% of medical devices for in-vitro diagnostics. This procedure assumes that the manufacturer or his Authorized Representative performs all the necessary actions for conformity assessment without involving the conformity assessment body, and issues a Declaration of Conformity with the requirements of the Technical regulations under it’s own responsibility.
Checklist of the Essential requirements of the medical devices to the relevant requirements is given in the Annex I to each Technical Regulation.
Prior to placing a medical device on the market it is also required to register the person responsible for putting it into circulation. Registration is performed by the State Service of Ukraine on Medicines and Drugs Control, a database is available on it’s website.
Design verification of medical devices for in-vitro diagnostics intended for self-control (for example, pregnancy tests) is carried out by the designated conformity assessment body on the basis of the submitted Application and a set of documents. If there is insufficient data of studies, the designated authority has the right to appoint additional studies in an accredited laboratory.
After receiving the design verification certificate, the manufacturer or his Authorized Representative, should conduct the “self-declaration” procedure, and register the Declaration of conformity at State Service of Ukraine on Medicines and Drugs Control.
The manufacturer’s audit (inspection) is carried out by the designated conformity assessment body at the location of the legal manufacturer, and in some cases also at the production sites. The procedure includes several stages:
- an assessment of the documentation,
- approval of the audit plan and program,
- the on-site audit,
- drafting an audit report (protocol) and the issuance of a certificate.
This procedure is quite expensive and time-consuming, but scope of the certificate can include a wide range of products.
The certificate of conformity is valid up to 5 years, and is the subject of an annual supervisory audit (significantly shorter and cheaper than the initial one).
Recognition of the EU certificate is not a stand-alone route: it’s an option for partial recognition of the conformity assessment results conducted by foreign notified body during national procedure. That route is approved by Article 45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”. The recognition is based on a certificate issued by a European notified body that has signed a Recognition Agreement with a Ukrainian designated Conformity Assessment Body.
The recognition procedure is not unconditional, i.e., the manufacturer must comply with all specific national requirements (designate an Authorized Representative, fill in Technical Documentation and national Essential requirements checklist, draw up a national Declaration of conformity, comply with the national language and labeling requirements etc.), then submit the documentation to the designated body, which has the right to partially recognize the results of another (foreign) body.
That route allows you to avoid physical on-site audit of the manufacturer by recognising the audit results performed by the EU notified body.
The certificate of conformity is issued for the validity period of the European certificate, and is a subject of annual supervision (confirmation of validity, without audit).
Batch certification implies the evaluation of documentation and laboratory tests, based on which results a certificate for a specific batch (Invoice) is issued. This procedure is an alternative for those medical devices that are imported infrequently, or for which there is no possibility to conduct an audit or the EU certificate recognition.
The procedure is not carried out for sterile medical devices as well as it is inappropriate for devices with a wide range of products – each type of device increases the cost of study. Due to the need to deliver to the study site and prepare for operation, it is also quite difficult to conduct batch certification of heavy equipment (MRI, CT, some X-ray equipment, etc.).
Labeling and instruction requirements
Medical devices introduced into the market of Ukraine must comply with all national requirements for packaging labeling and instructions for use (user manual).
In Ukraine there is no single legislative act that would describe the entire set of requirements for the medical devices labeling. Conformity assessment bodies check but do not approve the labeling, and more so – are not responsible for it. Manufacturers and it’s Authorized representatives are responsible for compliance with national labeling and language requirements.
Symbol of conformity to Technical regulations (conformity mark) can be affixed on the medical devices that meet all applicable requirements. Identification number of the conformity assessment body should be placed next to the symbol, if the procedure involves such body. The conformity mark must be affixed at least to the label and to the instructions for use (if applicable).
Mandatory labeling elements also include the name of the medical device or information for identification, the contents of the package or product characteristics, the name and address of the Authorized Representative of the manufacturer in Ukraine, the name and address of the manufacturer, country of origin, serial or batch number, expiration date, other specific information.
Labeling should be presented in the state (Ukrainian) language, other languages are allowed.
Starting January 1, 2021, medical devices must be labeled with measurement units according to the International System of Units (SI) (kilograms, centimeters, liters, etc.) in Latin letters.
Other applicable Technical Regulations
By affixing a conformity mark to a medical device the manufacturer or his Authorized Representative takes responsibility for ensuring that the requirements of all applicable Technical Regulations are met. The most common Technical Regulations that can apply to medical devices in addition to the “main” regulations are as follows:
- Technical Regulations on restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS2) approved by Resolution of the Cabinet of Ministers of Ukraine No. 139 dated March 10, 2017;
- Technical Regulations of radio equipment approved by Resolution of the Cabinet of Ministers of Ukraine No. 355 dated May 24, 2017.
If a medical device is subject to two or more Technical Regulations, it is necessary to carry out all conformity assessment procedures, as well as pay special attention to the overall requirements for labeling and the Declaration of Conformity. For example, the RoHS2 Technical Regulation requires the Declaration of Conformity to be supplied with medical device within supply chain – from the importer to the final consumer (which is not necessary under “medical regulations”).
Cratia provides professional services of conformity assessment (registration, certification) of medical devices products in Ukraine. We have an excellent knowledge of national legislation, necessary experience and resources.