Conformity assessment of medical devices in 2023: electronic registers and instructions, new requirements, and challenges

Cratia participated in the 32nd International Medical Exhibition “PUBLIC HEALTH 2023” as a leading professional consultant on medical products regulation. Viktoriia Moroz, Key Account Manager at Cratia, together with Mykola Matlaev, Lead auditor of the Conformity Assessment Department at Uni-Cert, conducted a 2-hour seminar on the topic “Introduction of medical devices for legal circulation”, attended by more than 120 participants.

The seminar took place within the framework of the exhibition dedicated to current issues in the medical industry, bringing together medical device manufacturers, authorized representatives, importers, distributors, and other healthcare organizations.

In the presentation, Viktoriia Moroz emphasized the importance of aspects related to the introduction of medical devices into circulation. The main topics included:

Compliance assessment, types of procedures, and classification: Viktoriia discussed the existing technical regulations for medical devices and highlighted the possibility of applying additional technical regulations, such as Technical Regulation 139 for electrical and electronic equipment, Technical Regulation 355 for radio equipment, and so on. She provided detailed information on various types of conformity assessments, including self-declaration, audits, recognition of EC certificates, batch certification, and design examination. The determination of risk class for medical devices was also explained.

Compliance with technical regulation requirements and required documentation: The presentation emphasized the importance for manufacturers and authorized representatives to comply with all requirements of applicable technical regulations. Special attention was given to the responsibilities and powers of authorized representatives and the necessary technical documentation for medical devices required for the Ukrainian market.

Conformity Marking and Labeling: The speaker highlighted the necessity of applying the conformity mark according to technical regulations on all medical products. She explained that this mark is the sole marking confirming compliance with all applicable technical regulations and indicating product safety to consumers. Requirements for the mark itself, the process of affixing, and mandatory elements on the label of medical devices, as defined by technical regulations and other legal acts, were discussed.

Instructions for use: Viktoriia outlined the key requirements for instructions for use. She emphasized that instructions must be included in the packaging of each medical device, providing important information for the safe and correct use of the product. Some medical devices, especially those in Class I, IIa, and some IVDs, may not require instructions if they can be safely used without them. However, in other cases, instructions are mandatory. Viktoriia also mentioned the possibility of providing instructions in electronic format through the company’s platform (https://e-ifu.com.ua).

Essential Requirements Checklist: This document is one of the first documents requested by the market surveillance authority during inspections. In fact, this document allows the manufacturer to determine compliance of their medical devices with the essential requirements specified in Annex 1 of the applied technical regulation.

Declaration of Conformity: Before introducing a medical device into circulation, the manufacturer or authorized representative must draw up a declaration of conformity containing important information about the product, its characteristics, the conducted conformity assessment, and more. It is important to note that this information must be provided in Ukrainian and meet the requirements of the applicable technical regulation.

Registration of Class I medical devices: Viktoriia Moroz drew attention to a new obligation – the registration of medical devices intended for entry into the e-Register exclusively through the user’s electronic cabinet starting from July 1, 2023. The speaker reminded about the transitional period, which was essential for refining technical solutions and preparing manufacturers and authorized representatives to work with the new e-Register. It was emphasized that the input of information about each medical device is done manually through the user’s cabinet, which can only be accessed using a qualified electronic signature. Viktoriia also discussed the possible reasons for refusal to include products in the e-Register of the State Service of Ukraine on Medicines and Drugs Control.

Market Surveillance and Quality Control: The specialist highlighted the measures taken in case of violations by manufacturers, authorized representatives, or distributors. Viktoriia noted that even if violations are related solely to labeling under the legislation or if it is entirely absent, this can lead to sanctions, restrictions, or even prohibitions on the introduction of such medical devices into the market. In the presentation, Viktoriia shared practical experience of market surveillance authority inspections, including the procedures, requested documents, and the duration of inspections. It is important to note that sanctions are imposed on the manufacturer (national), authorized representative (if the manufacturer is a non-resident), and distributor for each model, SKU, or batch of products that are deemed hazardous, pose a risk, and/or do not meet the requirements. This aspect can significantly impact the size of fines.

Implementation of Changes: Viktoriia explained how the process of implementing changes occurs, particularly from the perspective of an authorized representative. It is crucial for the authorized representative to have deep regulatory knowledge and practical experience to provide correct and competent responses to the manufacturer.

At the end of the seminar, the speakers called on all manufacturers, authorized representatives, and players in the medical field to adhere to the requirements of technical regulations, norms, and standards, as this ensures the safety and quality of medical products. Compliance with all requirements and procedures is mandatory, and it is important to understand that despite the complexity of these processes, they are aimed at the well-being and safety of the population.

After the seminar, there was an active open discussion in the audience, where participants had the opportunity to ask their questions directly to the seminar speakers, Viktoriia Moroz, Key Account Manager at Cratia, and Mykola Matlaev, Lead auditor of the Conformity Assessment Department at Uni-Cert who shared their experience in conducting conformity assessments with audits and recognition of EC certificates in Ukraine without audits.

If you have any questions, we will be happy to provide professional answers. We look forward to new meetings with you at future seminars or over a cup of coffee in our office.

Cratia offers services related to conformity assessment to technical regulations and registration with the State Service of Ukraine on Medicines and Drugs Control. We proactively and professionally organize the process within tight deadlines.

We provide:

• communication in a clear and professional language, including English;
• all necessary consultations regarding the requirements of technical regulations, the list of necessary documents, and the procedure for their legalization;
• professional expertise of documentation;
• individually developed bilingual (Ukrainian-English) texts of Agreement and Power of Attorney for our partners;
• translation of necessary documents at a high medical level;
• formation of the Technical File and the preparation of all national documents: labeling, instructions (user manuals), Essential Requirements checklists, Declaration of Conformity;
• Submission and registration with the State Service of Ukraine on Medicines and Drugs Control;
• Transfer of correctly executed documentation for keeping.

We provide preliminary consultations for free. You can reach us by phone at +38 (044) 364-33-55, 364-30-03, or email us at info@cratia.ua, or come to meet us at our office.