Conformity assessment of medical devices
Under the “medical device” we mean medical devices, medical devices for in-vitro diagnostics and active implantable medical devices.
Requirements for placing of medical devices on the market of Ukraine have changed since July 1, 2015: an “old” system of state registration has been replaced by national conformity assessment of medical devices to Technical regulation requirements.
Technical regulations on medical devices have been introduced as a part of the harmonization process of the Ukrainian legislation with the EU, under the European Union – Ukraine Association Agreement. National Technical regulations for medical devices are based on the relevant European Directives:
Technical regulation of Ukraine:
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
Despite the fact that Ukrainian Technical Regulations have been developed on the basis of the European Directives, the CE mark, EC certificate and EC Declaration of conformity do not give the right to place medical devices on the Ukrainian market. National certification procedure is required for import, placing on the market or putting into service of the medical device.
Whereas if all the specific conditions are met, the EC certificate allows fast-track national certification of the medical devices via partial recognition route.
Technical regulations set several certification routes, depending on the device class, its characteristics, and other aspects:
- Self-declaration with registration at the competent authority;
- Conformity assessment with audit of manufacturer;
- Accelerated and simplified procedure with partial recognition of the EC certificate;
- Batch certification.
Any chosen certification procedure, including the “recognition”, require that all national requirements are met: foregin manufacturer must designate the Authorized representative in Ukraine, the Technical file is filled according to the national requirements, labeling and instructions for use are prepared in Ukrainian language, Application for conformity assessment is submitted to the national certification body for higher classes, national Declaration of conformity is issued, low class device is registered at competent authority, national conformity mark is affixed on the device etc.
The transition period
During the two-year transition period from July 1, 2015 till 2017 it was allowed to place medical devices on the market of Ukraine either under the “old” state registration certificates or according to the “new” conformity assessment documents.
Such a transition period allowed the development of commodity stocks in Ukraine and transfer to the new requirements. Medical devices placed on the market under the “old” registration certificates can remain in the circulation until the expiry date, but not more than 5 years.
Since July 1, 2017 medical devices must comply with the requirements of the Technical regulations to be placed on the market of Ukraine.
The Ministry of Economic Development and Trade of Ukraine is the central executive body, which ensures the formation of a state policy in the technical regulation area.
The Ministry of Health of Ukraine is the central executive body, 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
National designated conformity assessment bodies (certification bodies) must be involved in the assessment procedures for “higher” classes of the medical devices. Role of the certification bodies is identical to “notified bodies” in the EU.
The certification body must be accredited by the National Agency for Accreditation of Ukraine for compliance with ISO/IEC 17021, ISO/IEC 17025 and ISO/IEC 17065 standards, supervised by the Ministry of Health and designated by the Order of the Ministry of Economic Development and Trade.
The conformity assessment body is chosen by the manufacturer or it’s Authorised representative, and the body’s identification number should be affixed to the labeling of the medical device next to the conformity mark.
There are 14 certification bodies for medical devices, 11 bodies for medical devices for in-vitro diagnostics and 4 bodies for active implantable medical devices (July 1, 2021).
Each body has it’s particularities, advantages and disadvantages: approach to pricing and timelines, current workload, the quantity and competence of the employees, language proficiency, the material and technical base, it’s approach to international cooperation and many other issues. Such particularities can make a significant impact on the body’s abilities, costs, timelines and other aspects.
The conformity assessment bodies can be both public and private.
Since the identification number of the body is affixed to the labeling, and since Application must contain the statement that another Application for identical devices will not be submitted to another body, choice of the certification body should be careful and weighed.
A non-resident manufacturer must designate an Authorised Representative in Ukraine. The Authorised representative must be a resident of Ukraine, a legal entity or an individual-entrepreneur. The name and address of the Authorised representative should be affixed on the labeling or in the instructions for use of each individual medical device.
Manufacturer designated an Authorised representative in writing. We recommend using both the Power of Attorney and the Agreement of the specific form.
The Authorised representative acts as a link between the Ukrainian market (distributors, consumers, certification bodies, market surveillance and other authorities) from one side and the manufacturer from another. Authorized representative shares with the manufacturer the responsibility for the quality and safety of medical devices placed on the market of Ukraine. The Authorised representative must keep the Technical documentation (certificate and declaration of conformity, Technical file, labeling, instructions and other documents) accessible for competent authorities for at least 5 years after the last medical device was placed on the market (15 years for active implantable devices).
The legislation determines that for specific medical device the manufacturer can designate only one Authorised Representative. That does not restrict the manufacturer from designation of different representatives for different types of medical devices.
The Authorised representative can act as an importer (distributor) or marketing organization, or it can be a third party.
LLC “Cratia Medtechnika” is a dedicated legal entity specialized in Authorized representative services. We are ISO 9001 certified by Bureau Veritas (Italy), have a strong and experienced team of experts, deep knowledge of national and european legislation and practices, and have prepared convenient business solutions.
Classification of products and conformity assessment procedures
The class and characteristics of the medical device determine the conformity assessment route and the necessity to involve the certification body. The higher the class of device, the more significant it’s risk, and the more complicated the certification procedure to be followed:
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 certification 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, medical devices class Im
With the involvement of the designated body at the stage of design examination and “self-declaration” at the next step.
Non-sterile medical devices Im, IIa, IIb, III classes 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 the certification body, choice between:
Sterile medical devices of any class, medical devices for in vitro diagnostic from List “A”, active implantable medical devices
With involvement of the certification body, choice between:
NB! Registration of the person responsible for placing the products on the market is mandatory for all I-class devices, including devices with measuring function and sterile devices, as well as for all medical devices for in-vitro diagnostics.
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 diagnostics. This procedure requires that the manufacturer or it’s Authorised representative will internally perform all the actions of the assessment of conformity of the medical device, without involving the designated conformity assessment body. After conformity has been assessed, the manufacturer or it’s Authorized representative issues the Declaration of conformity to the requirements of the relevant Technical regulations.
Requirements of Annex 1 (Essential requirements) must be met to demonstrate and prove the conformity of the devices. UA Annex 1 is based on MDD, IVDD and AIMDD but is slightly different.
Before placing medical devices on the market it is necessary to register the responsible person at the competent authority. Registration is performed by State Service of Ukraine on Medicines and Drugs Control based on the submitted set of documents.
Design examination of medical devices for in-vitro diagnostics intended for self-control (for example, pregnancy tests) is conducted by the certification body on the basis of the submitted Application and the set of documents (Technical file). In case of insufficient data on the conducted studies, the conformity assessment body has the right to inquire additional studies in the accredited laboratory.
After obtaining the certificate of design examination, the manufacturer or it’s 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 of the manufacturer is conducted by the certification body at the location of the legal producer, and at production sites (in some cases). The procedure consists of several stages, and includes assessment of Technical files and other documentation, approval of the audit agenda, on-site audit, preparation of a report (protocol), elimination of the findings (if any) and issue of the certificate.
Audit procedure is a comprehensive assessment route that allows a wide range of devices to be included in the certificate.
NB! Due to the COVID travel restrictions the audit can be performed remotely (video streaming).
The certificate of conformity is issued for a period of 5 years, and is subject to an annual supervisory audit (shorter and cheaper than the initial one).
Batch certification is a fast route to certify single-type medical devices from one shipment. Procedure includes examination of technical documentation and product testing in an accredited laboratory.
A certificate is issued for an exact number of medical devices, exact batch or serial numbers, under the exact Invoice and/or Agreement. Batch certification is not applicable to sterile products.
Recognition of EC Certificate is the fast and efficient conformity assessment route for medical devices that have been certified by EU notified bodies. The recognition route requires an Agreement between the relevant European notified body and Ukrainian certification body (at the moment such Agreements are signed with the app. 30 EU notified bodies).
Procedure is not defined in the Technical regulation on medical devices, but introduced and described by the Article 45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” and thus is applicable for all types of technically regulated products.
The procedure of recognition is not unconditional (it’s not an exchange of EC certificate for UA certificate): all the national requirements should be met (designation of an Authorised Representative, filling of the Technical file, language and labeling, national ER check-list etc.); Application must be submitted to Ukrainian certification body that will partially perform the assessment of the documents and partially recognize the results (protocols, reports) of the EU notified body.
That procedure avoids initial and annual audits, replacing them with assessment of the EU notified body’s reports. The certificate of conformity is issued by the validity of the European certificate.
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 language and labeling requirements.
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 register the labeling. Manufacturer and it’s Authorized representative are responsible for compliance with all 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.
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 basis of a 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 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.