Since July 1st, 2015 the legislative requirements regarding placing on the market of medical devices have changed: "old" system of state registration has been replaced by national conformity assessment of medical devices to Technical regulation requirements.
The introduction of the Technical Regulations is conditioned by the harmonization of the Ukrainian legislation with the European one, with the aim of gradual integration of Ukraine into the European Union. Technical regulations for medical devices are based on the relevant European Directives:
The EU Directive, on the basis of which the Technical Regulations were developed:
Technical regulation on medical devices, approved by
Resolution of Cabinet of Ministers of Ukraine №753 dated 02.10.2013
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Technical regulation on medical devices for in vitro diagnostic, approved by Resolution of Cabinet of Ministers of Ukraine №754 dated 02.10.2013
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Technical regulation on active implantable medical devices, approved by Resolution of Cabinet of Ministers of Ukraine №755 dated 02.10.2013
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
It should be noted that affixed CE mark at the product, as well as availability of a Certificate/ Declaration of Conformity to the European Directives on medical devices, does not authorize placement of the product on the Ukrainian market without passing the national conformity procedure
The European Declaration of Conform gives a clue as to the national procedure, applicable standards and decisions taken: it will be expedient to choose the same way to simplify the national conformity assessment procedure. The CE certificate can significantly simplify the receipt of the national certificate, since the results of the conformity assessment carried out by some EU notified bodies can be recognized in Ukraine.
All conformity assessment procedures, including the procedure of recognition the results, assume compliance with all requirements of national legislation, including: the appointment of Authorised Representative in Ukraine, the affixing of the necessary information on labeling, the drawing up of a national Declaration of Conformity, the assessment by the designated conformity assessment body or the registration of a person, responsible for putting the product on the market, affixing of symbol of conformity, etc.
On July 1, 2015, a two-year transition period began, during which the introduction of medical devices was allowed both on the basis of registration certificates with unexpired validity, and on the basis of Declarations/ Certificates of conformity.
Such a transition period allowed to develop commodity stocks in Ukraine and gradually move to meet the requirements of the new legislation. Medical devices entered into circulation through registration certificates are allowed for sale before the expiration date of the medical device, but not more than 5 years.
Since July 1, 2017, the putting of devices on the market through registration certificates has become impossible. All medical devices imported and put into circulation must comply with the requirements of the applicable Technical Regulations.
The Ministry of Economic Development and Trade of Ukraine is the central body of executive power, which ensures the formation of a state policy in the sphere of technical regulation.
The Ministry of Health of Ukraine is the central body of executive power, which exercises the functions of technical regulation of medical devices.
The State Service of Ukraine on Medicines and Drugs Control is the State Market Supervision Authority.
Conformity assessment bodies for medical devices
Works to assess the compliance of medical devices (with the exception of I-class products, not sterile and without measurement function, and the "others" group of medical devices for in vitro diagnostic) is performed by the designated conformity assessment bodies. In Europe, such organizations are called "notified bodies", but for Ukraine the term "conformity assessment body" is more accurate.
The conformity assessment bodies can be both public and private. The bodies are accredited by the National Agency for Accreditation of Ukraine for compliance with ISO/ IEC 17021, ISO/ IEC 17025 and ISO/ IEC 17065, supervision of the Ministry of Health and receive an appointment from the Ministry of Economic Development and Trade for works on the relevant Technical Regulations.
The number of conformity assessment bodies is constantly changing: from time to time new organizations receive the necessary accreditations and appointments, while others lose the status of the appointed body. The list of designated conformity assessment bodies is published by the Ministry of Economic Development and Trade.
The conformity assessment body is chosen by the manufacturer or his Authorised representative, and the conformity assessment body’s identification number is affixed to the labeling of the medical device. Despite the uniform requirements for accreditation, there is a big difference between the authorities in the approach to pricing, in the current workload and the timing of the works, in the quantity and competence of the staff, in language proficiency, in the material and technical base and many other issues. In combination, such nuances are critical, since they have a significant impact on the cost, duration and many other aspects of the initial procedure for assessing compliance and its annual maintenance.
Since the identification number of the conformity assessment body is applied to the labeling of the medical device, and since when submitting the Application for conformity assessment the manufacturer undertakes responsibility not to submit a similar Application to another conformity assessment body - the change of conformity assessment body is a rather complicated procedure. The choose of the conformity assessment body should be carefully and weighed.
A noteworthy detail is that accreditation of two designated conformity assessment bodies for medical devices was annulated:
- Filia "Medical Center for Conformity Assessment" of the State Enterprise "Ukrainian Pharmaceutical Quality Institute" from 02.22.2016,
- State Enterprise "State Medical Certification Center" of the Ministry of Health of Ukraine from 23.03.2018.
A manufacturer other than resident of Ukraine is required to appoint an Authorised Representative on the territory of Ukraine. The Authorised representative can be a resident of Ukraine, a legal or an individual entity. The name and address of the Authorised Representative should be indicated on the labeling or in the instructions of each individual medical device.
Manufacturer appoints an authorised representative by written mandate. To this end, we recommend to use both the Power of Attorney and the Agreement: since the Power of Attorney is convenient for granting rights to third parties (for example - for customs, for participation in tenders, etc.), and the Agreement describes not only the rights, but also the obligations of each party.
The Authorised representative acts as a link between the Ukrainian market (distributors and consumers appointed by the conformity assessment bodies, market surveillance authorities, law enforcement and other authorities) and the non-resident manufacturer, and also bears primary responsibility for the quality and safety of medical devices in circulation on the territory of Ukraine. The Authorised representative is required to keep the documentation (certificate and declaration of conformity, Technical file, labeling, instructions and other documents).
The legislation determines that for one medical device the manufacturer can appoint only one Authorised Representative, but does not restrict the manufacturer in appointing different representatives for different medical devices.
The Authorised representative can act as an importer (distributor) or marketing organization, and a third person who is not related to the commodity distribution chain. ‘Cratia Medtechnika’ offers outsourcing of the services of the Authorised Representative to manufacturers, who have several distributors for one type of medical device, or for other reasons designate a third organization as a representative. To perform this service we offer the experience and knowledge of a professional qualified team, implemented and certified quality management system according to the ISO 9001 standard, prepared convenient business solutions.
Classification of products and conformity assessment procedures
The class and characteristics of the medical device determine the conformity assessment procedure and the need to involve the designated conformity assessment body. The higher the class of device, the more significant the risk, and the more complicated the certification procedure:
Product class and specifications:
Conformity assessment procedure:
I-class medical devices, the group "others" of medical devices for in vitro diagnostic
Without involvement of the designated conformity assessment body through ‘self-declaration’ and registration of the person responsible for placing the products on the market
Medical devices for in vitro diagnostic, intended for self-control
With the involvement of the designated conformity assessment body at the stage of design examination and "self-declaration" at the subsequent stage.
Non-sterile medical devices of classes Im, IIa, IIb, III as well as medical devices for in vitro diagnostic from List "B" and medical devices for in vitro diagnostic, intended for self-control
With involvement of designated conformity assessment body, it is possible to choose between the procedure through the audit of production, or by certification of batch of products, or the procedure of recognition of CE Certificate
Sterile medical devices of any class, medical devices for in vitro diagnostic from List "A", active implantable medical devices
With involvement of designated conformity assessment body: either procedure through the audit of production or the procedure of recognition of CE Certificate
NB! Registration of the person responsible for placing the products on the market is mandatory for all I-class devices, including I-class devices with measuring function and I-class devices, supplied in sterile state, as well as for all medical devices for in vitro diagnostic.
Procedure of ‘self-declaration’ is applied only for the safest devices, which include about 30% of all medical devices, and more than 80% of medical devices for in vitro diagnostic. This procedure assumes that the manufacturer or his Authorised representative will independently perform all the actions necessary for conformity assessment, without involving the designated conformity assessment body, and issue a Declaration of Conformity to the requirements of the technical regulations.
To check and prove the compliance of medical devices to Technical regulation requirements, the Essential requirements check-list is used - the checklist is specified in Appendix 1 to each Technical Regulation.
Before placing of medical device on the market, it is also necessary to register the person responsible for products’ placing on the market. Registration is conducted by the State Service of Ukraine on Medicines and Drugs Control (SMDC) on the basis of the submitted dossier of documents.
Design examination of medical devices for in vitro diagnostic intended for self-control (for example, pregnancy tests) is conducted by the designated conformity assessment body on the basis of the submitted Application and the dossier of documents. In case of insufficient data on the conducted studies, the conformity assessment body has the right to conduct on additional studies in the accredited laboratory.
After obtaining the certificate of design examination, the manufacturer or his Authorised Representative, carries out the procedure of "self-declaration", and conducts registration in State Service of Ukraine on Medicines and Drugs Control before product’s placing on the market.
Audit (inspection) of production is conducted by a designated conformity assessment body at the location of the legal producer, and at production sites (in some cases). The procedure consists of several stages, and includes examination of documentation, approval of the audit agenda, on-site audit itself, preparation of a report (protocol) on the conducted audit and issuance of a certificate.
This procedure is quite expensive and time-consuming, but the certificate of conformity can include a very large range of devices.
The certificate of conformity is issued for a period of 5 years, and is subject to an annual supervisory audit (substantially shorter and cheaper than the initial one).
Certification of batch of products implies examination of technical documentation and examination of the products in an accredited testing laboratory. As the results of this procedure, a certificate for a specific delivery (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 the audit or recognize the CE certificate.
The procedure is not applicable for sterile medical devices, as well as it is appropriate for devices with a wide range of nomenclature - each type of product increases the cost of testing. Due to the need for delivery of devices to the test site and preparation for operation, it is also quite difficult to carry out certification of batch of heavy equipment (MRT, CT, some X-rays, etc.).
Recognition of CE Certificate is conducted by the designated conformity assessment body on the basis of 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 signed the relevant Agreement on Recognition the results with the Ukrainian designated conformity assessment body.
The procedure of recognition is not unconditional, that is the manufacturer must fulfill the national requirements (appoint an Authorised Representative, draw up the Technical Documentation, fill in the national check-list, compile a national Declaration of conformity, develop labeling and instructions for use, etc.) with further submission of documentation for conformity assessment to the designated body, which has the right to partially recognize the results of EU Notified body. Since the audit is the most costly and lengthy part of the works on conformity assessment, it is advisable to recognize the results of the works for this part.
The certificate of conformity is issued by the validity of the European certificate, and is also the subject to annual supervision (confirmation of validity).
For the national manufacturer
With the entry into force of the Technical Regulations, the main innovation was the mandatory availability of a quality management system (QMS) at the enterprise. The profile QMS for medical devices is approved by the State Standard of Ukraine (DSTU) ISO 13485 "Medical Products. Quality management system». For the safest products, the technical regulations do not establish rules for the presence of a profile QMS, and the manufacturer has the right to implement and maintain the system according to DSTU ISO 9001 "Quality management systems. Requirements."
Services related to the QMS can be conditionally divided into three stages:
- development of quality management system (at this stage the system is developed for a specific enterprise, taking into account its features, number of production lines, outsourcing or working with suppliers, number of employers);
- implementation of quality management system (an important stage of the correct functioning of the system, at this stage the system begins to "live" in the enterprise and moves from the written text to real application in production processes, the personnel is trained and the first internal audits are conducted by the company's employees);
- certification/ approval (after the introduction of the system and several internal audits, the enterprise is ready for certification/ approval of the system.) The authority visits the enterprise and audits the existing system. A certificate is issued as a result of a positive decision of an audit.
The technical specifications, which were previously the main document in national production, are receding into the past, and currently replaced into the Technical Documentation. The technical documentation is compiled in a manner similar to the European Technical File - prior to the commencement of the conformity assessment procedure.
Technical documentation should reflect the design, production and subsequent operation of the product. The scope and content of the information contained in the documentation depends on the type of product and requirements on necessary documentation to demonstrate the compliance with essential requirements of Technical regulation. The contents of the technical documentation will vary in each specific case, depending on the type of product, the risks in its manufacture, installation, operation and maintenance and the time of product availability on the market.
‘Cratia’ helped more than 30 national manufacturers to train personnel, develop, implement and maintain QMS as well as in drawing up technical documentation, conducting the necessary tests in accredited laboratories, preparing protocols and accompanying the conformity assessment procedure.
With the entry into force of the Technical Regulations, the definition of the manufacturer has also been updated: ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
Thus, the manufacturer has the right to transfer a part, or all performed production functions to another person.
A manufacturer who does not perform any production functions, but owns a trademark and places production in other enterprises is called OBL (Own Brand Labelling). Such a company is responsible before the consumer and the competent authorities for the quality and safety of the medical devices, as well as the name and address of the company are indicated on the labeling, in certificates and declarations.
The company that directly performs the production process is called OEM (Original Equipment Manufacturer). Such a company is only responsible before the customer of the production process - OBL. The name of the OEM is usually not specified on the labeling, but it can be indicated in certificates and declarations.
Practice of OEM-OBL production is widely used in the world, and allows the owner of the brand to minimize the cost of conformity assessment, freely choose OEMs and quickly expand the product range.
“Cratia” has extensive experience in development of OEM-OBL production on the basis of an existing relations distributor-importer, a national manufacturer or a new enterprise. We will help in the development and implementation of QMS, staff training, localization of technical documentation and support of the conformity assessment procedure.
Requirements regarding the labeling and instructions for use
Medical devices put into circulation on the Ukrainian market must comply with all national requirements for labeling of packaging and instructions for use (user manual).
There is no unified legislative act that would describe all of the requirements for the labeling of medical devices. The conformity assessment bodies check, but do not approve the labeling, and especially do not have responsibility for it. Manufacturer and his Authorized Representative, as well as the importer and distributor have responsibility for compliance with national requirements.
Cratia publishes and periodically reviews an internal document that contains summary information on the labeling of medical device; this document is available only to the company's customers and is not a subject to sale. We also presented part of the information in free access, on a separate page of our site.
Medical devices that comply with the requirements of the Technical Regulations are marked with a conformity mark. If the conformity assessment body is involved in the procedure conduction, the identification number of the body is placed next to the conformity mark. Each individual (unit) medical device is to be labeled.
The conformity mark must be affixed, at least, on the labeling and on the instruction (if it is provided).
The mandatory elements of the labeling are the name of the medical device or identification data, the contents of the package or product description, the name and address of the Authorised Representative of the manufacturer in Ukraine, the name and address of the manufacturer, country of origin, serial or batch number, expiration date and other specific information.
Labeling is required to be developed in the state (Ukrainian) language, other languages are allowed.
National standard DSTU EN 980:2007 "Graphical symbols for use in the labeling of medical devices" is developed to establish uniform requirements for the labeling of both national and foreign medical devices (DSTU EN 980:2007 is the identical translation of EN 980: 2007 "Graphical symbols for use in the labeling of medical devices") and recommended to be used by manufacturers.
The standard defines graphic symbols that are most often used by manufacturers to provide information on medical devices and are designed to reduce the need for multiple translations of words into different national languages.
Other applicable Technical Regulations
By affixing a conformity mark to a medical product, the manufacturer, or his Authorised Representative, assumes responsibility for meeting the requirements of all applicable Technical Regulations. The most common technical regulations, which fall under the medical devices are as follows:
- Technical Regulation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) as approved by Resolution No. 139 of the Cabinet of Ministers of Ukraine dated 10 March 2017
- Technical Regulation on legally regulated measuring instruments as approved by Resolution No. 94 of the Cabinet of Ministers of Ukraine dated 13 January 2016
If a medical device is subject to two or more Technical Regulations, all necessary conformity assessment procedures must be carried out, and special attention should be given to the consolidated labeling requirements and the Declaration of Conformity. For example, the applicability of the requirements of the RoHS2 Technical Regulation leads to the need to the product to be accompanied by Declaration of Conformity all stages of implementation, from the importer to the end user (which is not necessary for medical regulations).
Import, taxation and advertising
Import, wholesale and retail trade of medical devices is not a licensed type of activity. In fact, any legal entity that has relevant activities can import and sell medical products.
A preferential VAT rate of 7% (the usual rate is 20%) is applied to all medical devices, put into circulation on the base of document (declaration/ certificate) of conformity.
There are reasons for cancellation (withdrawal) of the preferential rate or refusal of customs clearance, such as:
- errors and inconsistencies in customs and accompanying documentation, labeling and certificates/ declarations of conformity,
- lack of registration of the person responsible for putting the product into circulation,
- lack of proper labeling of the product and others.
We already have a response to many of the questions that the importers face, either in the form of an internal expert opinion or in the form of an explanation from a designated conformity assessment body, a technical regulation body or in another form. For clients of ‘Cratia;’ such opinions and explanations are provided free of charge.
Advertising of medical devices, approved for use on the territory of Ukraine, is permitted. Advertising and promotion of medical devices are regulated by the Laws of Ukraine "On Advertising", "On Protection of Economic Competition", "On Protection from Unfair Competition" and others. National Ukrainian requirements are not harmonized with the legislation of any other country, and advertising and promotional materials do not undergo any state expertise or registration.
The responsibility for compliance with legal requirements lies with the manufacturer and his Authorised representative. We offer a professional services on the verification and approval of advertising and promotional materials for medical devices. The work is carried out by a team of qualified and experienced staff (regulatory specialist, medical editor and lawyer).
Medical devices are subject to state market surveillance, which is performed at all the stages of product circulation: during customs clearance, in commercial and storage facilities, during installation (putting into service), at trade fairs and exhibitions.
The State Market Surveillance Authority is the State Service of Ukraine on Medicines and Drugs Control (SMDC). SMDC conducts scheduled inspections in accordance with the approved sectoral plan, as well as unscheduled inspections on appeals from consumers, executive authorities, law enforcement agencies, etc.
The inspection focuses on the marking, instructions and accompanying documentation. In case of violations, the market surveillance authority may decide to restrict or prohibit the sale, remove or recall the products from service, and seller, importer and/ or manufacturer can be fined up to 85 000 UAH.
Protection from "gray" imports
Despite the existing mechanisms of market surveillance, in some segments of medical products the share of "gray" imports and counterfeit products is up to 60% and about 30% on average in the market. Such products are brought to the market by smuggling, forged documents (this is especially relevant for I-class products and IVD products from group ‘general’), or through unauthorized importers on the base of copies of authentic documentation.
The main channel for the distribution of illegal products are online stores and message boards. Also large volumes of products are realized through "manual" sales, and even through pharmacy and retail chains.
The volume of gray imports and falsified have increased considerably in the period 2014-2017 for a number of reasons: a moratorium on business checks, the unstable situation in the eastern regions of Ukraine, the transition period to new legislation, the sharp devaluation of the national currency and the fall in the purchasing power of the population.
Informal medical products, through aggressive dumping, capture a significant market share, and lead to significant financial and reputation losses for both the importer (distributor) and the manufacturer itself. Distributors of falsifier often do not bother with expenses for improper storage conditions, service and work with the consumer, training of doctors, ethical promotion, etc.
Mechanisms for effective protection are based on regulatory and legal mechanisms. More than three years, the company "Cratia" helps manufacturers and distributors in the diagnosis, treatment and prevention of this dangerous pathology of the market.
Technical regulations are the main legislative acts on conformity assessment of medical devices, however they do not contain exhaustive information and are a narrow-profile part of the legislation on technical regulation of products.
On the page of our website, we provided a list of the main legislative acts that we use daily in our work.
We also pay great attention to EU legislation and professional guidance documents, such as MedDev and IAF. If in a disputable situation the national legislation has no answer, then the reference to the relevant European document will be used as a weighty argument.
Our services and activities
“Cratia” offers services of conformity assessment (certification) of medical devices to Technical regulations. We have the necessary knowledge, experience and skills to carry out all the necessary works, perfectly speak and write in English. We will take responsibility for organization of the process, help to form the dossier according to legislation requirements and perform the conformity assessment procedure in the shortest possible time.
In addition to the main services, we are also ready to offer:
- Outsourcing of the service of the Authorised Representative of the manufacturer in Ukraine;
- Legal support of the manufacturer, authorised representative or distributor (importer);
- Development and implementation of QMS according to ISO 9001 and ISO 13485;
- Development technical and medical documentation, conduction of testing and research;
- Construct an effective protection against gray imports (counterfeit products).