On July 1, 2017, the so-called “transition period” for introduction of new rules for legalization of medical devices in Ukraine (note: hereinafter the term “medical device” will include inter alia such as for in vitro diagnostics and active implantable devices) ended in Ukraine, the essence of which is in the mandatory procedure for assessing conformity of products with the requirements of special technical regulations .
The procedure for legalization of medical devices replaced their state registration, which the State Service of Ukraine on Medicines and Drugs Control conducted at the appropriate time in accordance with Resolution of the Cabinet of Ministers of Ukraine of 09.11.2004, No. 1497, corresponds to the European integration course declared by Ukraine since all the processes were implemented in accordance with the relevant EU Directives in the field of medical devices.
When passing the conformity assessment procedures, depending on the class of the medical device, manufacturers (their authorized representatives) legalize the right to introduction of medical devices into turnover in the customs territory of Ukraine.
Against the background of state registration, the conformity assessment procedures are carried out by the state-designated bodies (Notified body), both private and state-owned companies that received a special designation according to the established procedure. The conformity assessment body Improve Medical received such designation under No. UA.TR.120.
Thus, the Ukrainian conformity assessment bodies, based on the results of the conformity assessment procedure, confirm that the manufacturers (their authorized representatives) introduce safe products into turnover (presumption of conformity).
After products are released in the market, the manufacturers (their authorized representatives) and the State Service of Ukraine on Medicines and Drugs Control as a specially designated market supervision authority are jointly obliged to maintain safety of life cycle of the products in turnover.
To achieve this goal, the EU has a comprehensive post-marketing surveillance system, which should be divided into two components: state supervision in the representative of the State Service of Ukraine on Medicines and Drugs Control and its territorial units and the internal post-marketing system of the manufacturer (its authorized representatives). Both processes are aimed at ensuring safety of medical devices.
The concept of “supervision” should be interpreted as the need to gain practical knowledge about possible future events or incidents – potential threats to life/health of patients and users of medical devices. For this purpose, the special incidents forecast and prevention methods are used (potential harm when using medical devices).
The European post-marketing surveillance system includes all the above methods (elements), but in practice it is applied to the incidents that have already occurred.
Further, we consider the key provisions that require attention from the operators of the market of medical devices.
1. Product safety
Applying the post-marketing surveillance system, first of all, the manufacturer (its authorized representative) must determine the legislative basis for the standards application. In fact, according to the effective regulations, the operators are obliged to provide only safe products in the market (put into turnover).
First of all, safety of medical devices is confirmed by their compliance with the national standards in Ukraine, which are harmonized with the European ones. The list of harmonized national standards is made by the Ukrainian Agency for Standardization (note: SE “UkrNDNTS”) and is approved by order and officially published by the Ministry of Health of Ukraine.
If there are no requirements for ensuring a product safety in the national standards, the manufacturer and the market surveillance authority may apply other regulations and/or technical documents in the following order:
- National standards of other countries to ensure product safety harmonized with the European and international standards;
- Regional standards for ensuring product safety in accordance with the international treaties of Ukraine – standards adopted by the regional standardization organization and accessible to a wide range of users;
- Standards of Ukraine for ensuring product safety – regulatory documents based on consensus, adopted by a recognized body that establishes rules, instructions or characteristics about activity or its results for general and repeated use, and are aimed at achieving an optimal degree of orderliness in a particular area;
- Codes of best practice to ensure product safety in the appropriate industries – regulatory documents containing recommendations on practices or procedures for design, manufacture, installation, maintenance or operation of equipment, structures or products;
- Achievements of science and technology in the field of product safety;
- Expectations of consumers (users) regarding product safety in the usual or reasonably anticipated conditions of use (including service life, installation and maintenance requirements, etc.).
2. Post-marketing – Ukraine
In the Ukrainian legislation, the term “post-marketing surveillance” is not envisaged, but in part it falls under the concept of “market surveillance” carried out in relation to medical devices by the State Service of Ukraine on Medicines and Drugs Control.
In fact, post-marketing surveillance should have a centralized system for recording all cases that pose a serious risk to the patient’s health. These requirements for informing the competent authorities and conformity assessment bodies are established in the Ukrainian technical regulations. They are similar to those effective in the EU.
The practice of market surveillance for the State Service and its territorial bodies is relatively new. Nevertheless, starting from the second quarter of 2017, the agency has already been quite closely engaged in surveillance of the market of medical devices. In particular, according to the reporting data of the State Service, last year it carried out 615 planned inspections of product characteristics, based on which 134 decisions were made to apply restrictive (corrective) measures: of which in 133 cases turnover of the products in the market was limited and in one case the products were completely withdrawn from turnover.
The State Service conducts planned market surveillance according to the sectoral inspection plan, which is formed at the end of the current year for the next year and is published on the website of the State Service.
3. Post-marketing – European Union
The obligations of the manufacturer (its authorized representative), powers of the public agency and the Conformity Assessment Authority, recommendations on post-marketing surveillance systems and mutual notification in the European Union are set out in Directives 93/42, 90/385, 98/79 and recommendations of the European Commission MEDDEV 2.12-1, rev 8 and MEDDEV 2.12-2, rev 2.
According to Articles 8 and 10 of EU Directive 93/42, each EU state must take the necessary measures to remove a medical device from the market (restrictions on its release, commissioning) in cases where it was established that, if properly designed, maintained and used, the medical device may threaten health or safety of patients, users, or others.
The competent authorities of the EU states are obliged to ensure centralized recording and assessment of information regarding:
- any malfunction or deterioration of the characteristics and/or functional properties of the medical device
- any discrepancies in the instructions for use, which can/could lead to death of the consumer/user or to a significant deterioration in their health status;
- any technical or medical reasons related to the characteristics or functional properties of the medical device, leading to a systematic recall by the manufacturer of medical devices of the same type.
However, the Regulation (EU) 2017/745 of the European Parliament and the Council of Europe on medical devices adopted in April 2017 established substantially new, more stringent standards for the post-marketing surveillance system. The regulation governs presentation, analysis and investigation of all incidents involving medical devices, and the system for taking corrective and preventive measures.
Currently, Ukraine has not established clear regulatory standards regarding the terms of filing, analysis and investigation of all incidents with medical devices. The questions of taking corrective and preventive measures remain procedurally open. In this regard, the responsible manufacturers during implementation of the quality management system (QMS) and conformity assessment bodies during analysis of QMS documents and procedures are guided by the instruments of the European Commission and the ISO standards.
4. Post-marketing – Manufacturer
The internal post-marketing surveillance system for medical devices provides the manufacturer with an efficient service to improve safety criteria of its products and minimize negative economic consequences for the business, e.g. in case of limitation of market turnover of medical products.
In fact, it is a system for monitoring safety and effectiveness of medical devices put into turnover and operation of medical devices, aimed at identifying any changes in the risk/benefit ratio, side effects, recording incidents, taking corrective and preventive measures.
The post-marketing surveillance system is introduced into the overall quality management system of the manufacturer. Moreover, in accordance with clauses 7.2, 8.2.1 and 8.5.1 of the relevant ISO 13485 standard, the conformity assessment body should establish that the manufacturer has documented procedures and methodologies for the post-marketing surveillance system, and feedback with the customer.
In this regard, it is necessary to cite some general obligations of the manufacturer, which must be taken into account when creating the post-marketing surveillance system:
1. The manufacturer should inform the authorized representative in Ukraine of its post-marketing surveillance system and empower the latter to receive, process and store all information regarding unwanted incidents that occurred with medical devices in Ukraine.
2. The manufacturer is obliged to analyze and evaluate all information about the products, which comes from the authorized representative, distributor, government agencies, patient or user. Based on the analysis, the production or other process should be adjusted to prevent the identified risks associated with safety and use of medical devices.
3. The manufacturer should have a qualified specialist responsible for collecting, analyzing, and monitoring of information obtained through the post-marketing surveillance system. The specialist should provide the results of the analysis to the top management of the company.
4. The manufacturer and its authorized representative must cooperate with regulatory authorities, Conformity assessment authorities, importers and distributors in Ukraine regarding exchange of information on side effects, incidents, corrective actions.
5. Using the system, the manufacturer plans, conducts post-marketing control clinical trials/evaluations. According to their results, it re-evaluates the risks and updates the materials of the technical file and makes changes in the product design, production process and information for the user. The manufacturer notifies all parties concerned about the above activities: the market surveillance authority of the State Service for Ukraine, conformity assessment bodies, authorized representatives and users.
Galina Goy, conformity assessment auditor of IMPROVE MEDICAL
 approved by Resolution of the Cabinet of Ministers of Ukraine of 02.10.2013, No. 753-755.