Newsletter on medical devices: suspension of UMCS, cancellation of sanitary conclusions, biocides as medical devices, regulation of aerosols

We share updates regarding the regulation of medical devices in Ukraine:

• Suspension of accreditation of certification body “UMCS”;
• Cancellation of sanitary conclusions for medical devices as of October 1, 2023;
• Certain disinfectants are now classified as medical devices;
• New Technical regulations for aerosol sprayers;
• Metrological verification of medical devices.

Suspension of accreditation and designation of certification body “UMCS”
On September 22, 2023, the accreditation was revoked, and on September 26, 2023 the validity of the designation (analog of notification in EU) of the conformity assessment body State enterprise “Ukrainian Medical Certification Center” (SE “UMCS”, UA.TR.039) was suspended.

What should you do if your certificate is issued by UMCS?
Certificates of conformity from UMCS are not withdrawn but lose their validity on the date of the next scheduled surveillance audit, which must be conducted every 12 months. To introduce new medical devices into circulation after that date, it is necessary to transfer the certificate to another designated conformity assessment body. This transfer does not occur automatically: the manufacturer or its authorized representative must submit an Application to another body, go through the assessment procedure, and receive a new certificate of conformity. The manufacturer or its authorized representative chooses a new certification body.

Cancellation of sanitary “SES” conclusions for medical devices as of October 1, 2023
From October 1, 2023, the Law of Ukraine “On the Public Health System” came into force, which caused the expiration of the Law of Ukraine “On Ensuring Sanitary and Epidemiological Welfare of the Population” and excluding conclusions of the state sanitary-epidemiological expertise from the Law of Ukraine “On the List of Permitting Documents in the Field of Economic Activity”.

Therefore, conclusions of the state sanitary and epidemiological expertise in Ukraine are no longer issued and should not be required from the operators of the medical devices market.

Certain disinfectants (biocidal products) are now classified as medical devices
The implementation of the Law of Ukraine “On the Public Health System” has led to the adoption of a new regulation of disinfectants, which was approved by the Cabinet of Ministers of Ukraine (CMU) Resolution No.863 dated August 15, 2023. Resolution No.863 came into effect on October 1, 2023, replacing the previous registration (re-registration) procedure for disinfectants approved by CMU Resolution No. 908 dated July 3, 2006.

The new procedure has resolved the ambiguity concerning the dual regulation that previously existed for post-sterilization cleaning products, “cold” sterilization, and quality control of medical device sterilization. According to the previous CMU Resolution No.908, these agents were classified as disinfectants, but according to Annex 2 to the Technical Regulation on medical devices, such products were classified as medical devices of class IIa or IIb.

Thus, agents specifically designed for disinfecting medical devices are classified as medical devices.

New Technical Regulation for aerosol dispensers
From November 25, 2023, the new Technical Regulation for aerosol dispensers, approved by the CMU Resolution No. 154 dated February 21, 2023, came into effect. This was developed based on the European Council Directive 75/324/EEC.

Medical devices provided in the form of aerosol dispensers fall under the provisions of this Technical Regulation. To introduce aerosol dispensers into circulation, such products must be marked with a conformity sign in the shape of an inverted epsilon, indicating that the aerosol sprayer meets the requirements of Regulation No. 154. The Technical Regulation also establishes several specific features regarding product labeling, including the mention of the importer’s name and address, specific notes, and symbols related to respective warnings, etc.

Reminder: the conformity mark on products indicates that the manufacturer has assessed the conformity with all applicable technical regulations of Ukraine. Medical devices most often fall under the following technical regulations:

• For electronic and electrical medical devices: Regulation 139 (RoHS2);
• For medical devices with WiFi, Bluetooth, or another radio module: Regulation 355 (RED);
• For products that are also personal protective equipment: Regulation 771 (PPE).

Such regulations may impose additional requirements for the product, accompanying documentation, registration, and labeling. If a medical device falls under several technical regulations, the manufacturer must draw up a single Declaration of сonformity for all applied regulations, which can be in the form of a dossier.

Metrological verification of medical devices
Cratia has prepared an article on the topic of “Metrological verification of medical devices” to provide a comprehensive and expert view of the regulation of medical devices with a measuring function, which includes devices such as thermometers, sphygmomanometers, pulse oximeters, defibrillators, ultrasound devices, etc. Such medical devices are regulated not only by the Technical Regulation on Medical Devices but also by metrological legislation. An article about special requirements for medical devices with a measuring function is attached to the letter.

Cratia offers services of conformity assessment of medical devices and registration at the competent authority. We proactively and professionally organize the process within tight deadlines.

We provide:

• clear and professional communication in English;
• Authorized representative services;
• consultations and advisory on requirements of technical regulations, the list of necessary documents;
• internal assessment of documentation (gap analysis, feasibility study);
• individually developed bilingual (UA-ENG) texts of Agreement and Power of Attorney;
• translation of necessary documents at a high medical level;
• filling of national documents: Application, labeling, instructions for use (manuals), Essential Requirements checklists, a draft of Declaration of Conformity, cover letters etc.;
• Submission and follow-up of assessment of the documents;
• Organization of audit, EC certificate recognition or registration at the competent authority;
• Maintenance of the registration/certification.

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.