At July 01, 2015 marketing authorization requirements for medical devices have changed: system of state registration has been replaced by national conformity assessment to Technical regulations. Ukrainian Technical Regulations are based on relevant EU Directives 93/42/EEC, 98/79/EC and 90/385/EEC. 

National conformity assessment of medical devices  | Cratia

The medical devices, which have obtained certificate of state registration may be placed on the market without passing the conformity assessment procedure until the expiration of the validity of the state registration certificate, but no later than July 1st, 2017 (whichever is the earlier). The selling of such medical devices is permitted until the use-by date expiration, which allows accumulation of commercial reserves (stock) on the territory of Ukraine and gradual implementation of the new legislation. It is impossible to renew registration certificate or to implement any changes.

Read our article: The new requirements for placement of medical devices on the market of Ukraine: conformity assessment according to the Technical Regulations

Affixed CE mark at the product labeling, as well as availability of documents confirming compliance with the European Directives for medical devices or approval of devices sale on the European markets, does not authorize placement of the product on the Ukrainian market without passing the national conformity procedure. Moreover, previous registration does not facilitate this process and the results of technical, preclinical or clinical examinations do not provide confirmation of conformity to Technical Regulations.

The European conformity assessment route suggests approach to the procedure in Ukraine. It will be efficient to follow EU procedure and decisions, using almost identical documentation to simplify national conformity assessment procedure.

All medical devices that should be put into market from July 01, 2915 for the first time – national conformity assessment to Technical regulations (Decrees of Cabinet of Ministers of Ukraine 753, №754, №755 dated October 02, 2013) is required. 

Procedure of national conformity to Technical regulations depends on class of medical device and allows for some classes to choose between inspection and laboratory testing. 

Class of medical device defines necessity of involving of authorized (notified) body: safest products can be introduced to the market through self-declaration conformity procedure to Technical regulation of Ukraine. Other medical devices require either assessment of documentation and inspection of the manufacturing site that will grant certificate for 5 years, or to follow every-batch conformity assessment that result to certificate for exact shipment.

Self-declaration is applied to:

  • Medical devices of I class, not sterile, without measuring functions according to provision of Technical regulation on medical devices (Decree of CMU №753);
  • Analyzers, reagents and other IVD products, which are not included in the lists “A” and “B” of the Technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754);

Conformity assessment involving authorized body is required for:

  • Sterile medical devices of I class, measuring medical devices, all medical devices of classes IIa, IIb, III according to provision of Technical regulation on medical devices (Decree of CMU №753);
  • In-vitro: self-testing devices; reagents, calibration and control materials of lists “A” and “B” of the Technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754);
  • All active implantable medical devices according to Technical regulations on active implantable medical devices (Decree of CMU №754);

 

The conformity assessment procedure with the involvement of the authorized body may be conducted using one of the following routes: 

  1. In form of assessment of the Quality Management System at the manufacturing site (the on-site inspection), which results in issuing of the conformity certificate for medical devices valid for 5 years related to the quality management certificate valid for 3 years.   
  2. In form of conformity assessment of each batch, which implies issuing of the certificate for the certain batch (shipment) of medical devices after documentary expertise and sample examinations.

Conformity assessment of quality management system of manufacturer is more comprehensive, time-consuming and costly procedure in comparison with the batch procedure. But in the long run the estimated costs for the fourth-fifth batch assessment may exceed those for manufacturing site inspection. 

Documentary expertise, on-site manufacturing inspections and testing of samples of medical devices are being performed by national authorized bodies (analogue of notified bodies in EU). Nine (9) state and private bodies have granted accreditation till August 2015 from National Accreditation Administration of Ukraine and Ministry of Economic Development.

The Application for conformity assessment and related documents are submitted to one of the authorized bodies, as well as the letter of guarantee proving that the same Application has not been submitted to another authorized body. The authorized bodies may vary from the point of view of the assigned devices, the number of experts and inspectors, which can affect significantly on timing and other procedural aspects. The choice of the conformity assessment body is extremely important, as it can predetermine the course of the entire procedure. It is not recommended to change the authorized body, as in such case all the process must be restarted from the very beginning and necessary payments must be paid again.

 

One of the mandatory requirements of the Technical Regulations for medical devices of all classes and for all types of the conformity assessment procedures is the assignment of the authorized representative of the manufacturer in Ukraine, in cases when the manufacturer is not a resident of Ukraine. The definition of the authorized representative is given in the Technical Regulations:

 

«authorized representative is any legal entity or individual entrepreneur, being a resident of Ukraine, or registered in accordance with the laws of Ukraine, the representative of the foreign company, which has duly proved authorization of the manufacturer to perform on its behalf legal actions on the obligations of the manufacturer under present Technical Regulations»

 

The authorized representative in Ukraine serves as a liaison between Ukraine (conformity assessment bodies, market supervision bodies, revenue bodies, consumers etc.) and the manufacturer and performs postmarketing surveillance. The authorized representative in Ukraine acts in accordance with the Power of Attorney or Manufacturer’s Representative Agreement. The agreement is preferable for assigning rights and obligations of both parties, as well as responsibilities of the authorized representative concerning quality and safety, communication timing, reaction to complaints and reports of adverse events and many other aspects of activity.

The authorized representative must keep all documentary records for at least 5 years (for implantable medical devices the term is not less than 15 years) in order to provide access to them upon the request of public authorities and / or conformity assessment bodies.

The outer packaging and / or in the instruction for use of the medical device shall contain the name and the address of the authorized representative. At the same time, each medical device (type / model) must be linked to only one authorized representative. At the manufacturer’s decision a distributor, representative office or a third party may be authorized as the representative.

Designation of the Representative office in Ukraine as authorized representative of the manufacturer carries serious risks as to violation of the current legislation requirements regarding the ban on conducting certain business activities: performing regulatory activities concerning products manufactured by other factories of the holding or by contract manufacturers may be regarded as rendering of services to third parties, which is a commercial activity.

National conformity assessment of medical devices  | Cratia 2

Package labeling and instruction for use. Placing of the national conformity mark, indication of the name and address of the authorized representative in Ukraine are among the major introductions to labeling of the medical devices, which obtained the conformity certificate. General description of the conformity mark is approved by the Resolution of the Cabinet of Ministers of Ukraine #1184 dated 30.12.2015, while requirements for its size are specified in the text of the Technical Regulations. If the authorized body was involved in the conformity assessment procedure, it is necessary to indicate its identification number next to the mark.

Some new requirements to the instruction for use were also introduced. They are listed in the Technical Regulations and must be considered when putting the medical device on the market.

Information on the label and text of the instruction for use must be provided in Ukrainian language, according to the Law of Ukraine “On the Principles of State Language Policy”, and may be additionally translated into other languages.

Market Supervision. The Technical Regulations for medical devices are part of the national technical regulation system, which includes control surveillance of the quality, safety and compliance to declared requirements after introduction of medical device and its consequent placement on the Ukrainian market. The State Administration of Ukraine on Medicinal Products is the main market supervision body for medical devices with conformity certificates.

According to the Article 15 of the Law of Ukraine “On state market supervision and control of non-food products”, the representatives of the market supervision bodies are authorized to carry out documentary checks and take product samples for testing and examinations. In addition, they are granted with free access to:

  • commercial and storage facilities;
  • places of devices use during its assembling and/or putting into service;
  • medical devices exhibitions or demonstration places;
  • customs storage, when clearance is suspended as a result of control measures.

 

“Cratia” offers services of conformity assessment on Technical regulations. We have the necessary knowledge, experience and skills to carry out all the necessary works and activities. We will take responsibility for organization of the process, fill in Application and dossier according to legislation requirements and perform the conformity assessment procedure in the shortest possible time. We provide:

  • all necessary consultations regarding the requirements of Technical regulations, list of necessary documents and their legalization requirements, scientific advices etc .;
  • the professional expertise of the documentation prior to submission to the authorized body;
  • individually designed for our partners bilingual (Ukrainian-English) text of the Agreement on designation of Authorized representative in Ukraine;
  • objective and professional advices on the choice of the authorized body considering experts, political and economic situation, prospects of development and so forth;
  • translations of necessary documents, including proofreading and notary certification if required;
  • on the basis of Power of Attorney we represent your interests in authorized bodies: negotiate, submit documents, obtain comments, coordinate the procedure of inspection, take samples, conduct payments etc.;
  • in case of deficiencies we send them to you translated with our advices;
  • control of timing, steps, legal compliance etc.;
  • localization of package labeling and instruction for use (manual);
  • drafting of Declaration of conformity to Ukrainian Technical regulations. 

 

All preliminary consulting and advices are free of charge, do not hesitate to contact us by e-mail info@cratia.ua, tel. +38 (044) 332-42-94 or visit our office