Metrological verification of medical devices in Ukraine

The measuring function is an integral part of many medical devices: analyzers, thermometers, tonometers, pulse oximeters, defibrillators, electrocardiographs, ultrasound machines, and more. The reliability and accuracy of such devices play a crucial role in diagnosis, treatment, and prevention. Medical devices must ensure high measurement quality, both when the product is put into operation and throughout its service life.

How is metrological accuracy ensured when introducing and operating a medical device? What documents are needed to confirm this? How often and how is accuracy checked during the operation of a medical device? What is the liability for violations of metrological legislation?

In this article, we provide answers to these and other questions about the requirements for medical devices with a measuring function.

Does metrological legislation apply to medical devices?
The main legislative act regulating metrology and metrological activity is the Law of Ukraine “On Metrology and Metrological Activity” dated June 5, 2014, No. 1314-VII (hereinafter – the Law).

According to the definition given in the Law, measuring instruments (MI) refers to measuring instruments, measuring systems, material measures, standard samples, and any parts of measuring instruments or measuring systems if these parts are subject to special requirements and separate conformity assessment.

According to Article 3 of the Law, the protection of life and health protection of citizens falls within the field of legislatively regulated metrology.

Therefore, medical devices with a measuring function are also measuring instuments and are subject to metrological legislation and its requirements.

How is the conformity assessment of medical devices with a measuring function conducted?
According to the Law, the conformity assessment of measuring instruments is carried out in cases and according to procedures established in the respective technical regulations.

Pursuant to Article 30 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, to apply the conformity mark, it is necessary to conduct a conformity assessment according to all applied technical regulations. This means that the manufacturer or its Authorized Representative in Ukraine must check all applied Technical Regulations and carry out the corresponding conformity assessment procedures before affixing the conformity mark.

Possible applied technical regulations for medical devices with a measuring function are the specific medical Technical Regulations (Resolutions of the Cabinet of Ministers of Ukraine No. 753, 754, and 755), the Technical Regulation of legislatively regulated measuring instruments (Resolution of the Cabinet of Ministers of Ukraine No. 94), the Technical Regulation on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Resolution of the Cabinet of Ministers of Ukraine No. 139), the Technical Regulation on radio equipment (Resolution of the Cabinet of Ministers of Ukraine No. 355), and others.

Technical regulations on medical devices set requirements for products with a measuring function, especially regarding the production process to ensure conformity with metrological requirements. When conducting the conformity assessment, the manufacturer or its Authorized Representative must demonstrate the stability and accuracy of measurements in the conformity checklist to the Basic Requirements and provide confirmation in the technical documentation. The designated conformity assessment body must be involved in the conformity assessment when it comes to a medical device with a measuring function. However, this is not required for the conformity assessment of in vitro diagnostic medical devices, and therefore most IVDs undergo the internal control procedure.

Thus, specific technical regulations contain special requirements regarding measuring functions, the assessment of which is either placed on the designated body or the manufacturer.

From January 19, 2020, medical devices were excluded from the scope of the Technical Regulation of legislatively regulated measuring instruments No. 94. This implies that Technical Regulation No. 94 does not apply to medical devices, so its requirements need not be considered.”

Requirements of other technical regulations, such as the technical regulation restricting the use of certain hazardous substances in electrical and electronic equipment, radio equipment regulations, which may also apply to medical devices, do not contain any requirements regarding measuring functions.

The document of conformity assessment, based on which the medical device is placed on the market or put into service, is a declaration of conformity to all applied technical regulations. By issuing the declaration, the manufacturer of the medical device ensures and guarantees that the medical device meets all declared requirements and specifications.

Accordingly, the declaration of conformity and the certificate of conformity, if required by conformity assessment procedures, are sufficient for the release or operation of medical devices with a measuring function.

How is the quality of measurements ensured?
As we found out earlier, medical devices are measuring tools, but they do not fall under technical regulation #94 of legislatively regulated measuring instuments. To ensure the compliance of medical devices with a measuring function with metrological requirements, it is necessary to be guided by the Law of Ukraine “On Metrology and Metrological Activity” and its subsidiary legal regulations.

The law stipulates that legislatively regulated measuring instruments in operation are subject to periodic verification and verification after repair.

Verification of measuring instruments is a set of operations that include checking and marking and/or issuing a verification document for the measuring tool, which establish and confirm that the specified tool meets the established requirements.

Various types of verification are provided, such as: verification after repair, periodic, extraordinary, expert, and inspection verification. Any measuring tools can be subjected to all types of verification, except for periodic, which is applied only to measuring tools included in the list of categories of measuring tools in accordance with Resolution No. 374.

Medical devices and in vitro diagnostic medical devices listed in Resolution No. 374 are subject to periodic verification. The quality of measurements of medical devices during their operation is ensured by verifications, including periodic ones.

Is the primary verification of medical devices with a measuring function performed?
The applied technical regulations do not establish requirements for the conduct of primary metrological verification for medical devices with a measuring function. The concept of primary verification originated from the Law of Ukraine “On Metrology and Metrological Activity”, as until a certain time the Law provided for such a type of verification as primary.

However, in 2019, based on the Law of Ukraine “On Amendments to Some Legislative Acts of Ukraine regarding the Implementation of Acts of European Union Legislation in the Field of Technical Regulation” dated June 6, 2019, No. 2740-VIII, the provision on the mandatory primary verification was excluded from Article 16 of the Law.

Currently, the Law does not provide for such a type of verification as primary, so there is no legal basis for its implementation.

Thus, the primary metrological verification of medical devices with a measuring function before their supply to the end consumer is not mandatory according to the current legislation of Ukraine.

It is worth considering a few exceptions:
Exception 1: Extraordinary verification, according to item 18 of section II of the Order of the Ministry of Economy No. 193, indicates that the medical devices, which are stored and not used, are not subject to periodic verification but are subject to extraordinary verification immediately before being put into operation or rented out. Such a device should have a visible mark that it is not in use, only stored, and the fact that the device is stored and not used must be documented.

Exception 2: The possibility and/or necessity of verification before putting into operation can be specified in the manufacturer’s technical documentation or its operational documents.

Thus, although primary verification for medical devices with a measuring function is not mandatory according to current legislation, one should consider exceptions that may be specified in the manufacturer’s technical documentation or regulated by other normative acts.

How and when is periodic verification conducted?
Article 17 of the Law stipulates that measuring instruments (MI) in operation are subject to periodic verification.

According to the Law, periodic verification of MI is a verification conducted during the MI operation period at a specified interval (inter-verification interval). According to Resolution № 1195, the inter-verification interval is the time or operating duration between two consecutive verifications of the legislatively regulated measuring instrument, during which the metrological characteristics of such MI must comply with the established requirements.

According to Part 3 of Article 17 of the Law, business entities are obliged to timely submit MIs in operation for periodic verification, observing the established inter-verification intervals.

In conclusion, we believe that the calculation of the first verification begins from the moment the MI is put into operation. However, at the same time, if the product was not in operation (for example, after purchase) and is stored, it is advisable to conduct an extraordinary verification before its use. In this case, taking into account paragraph 18 of Order №193 and p. 2 of Resolution № 1195, the inter-verification interval will be calculated from the date of the extraordinary verification).”

When else should verification be conducted?
In this section, we will briefly consider other types of verifications, such as post-repair verification, extraordinary verification, expert verification, and inspection verification.

Verification after repair is carried out after repair works, including the dismantling, transportation, and installation of measuring instruments.

Extraordinary verification is carried out if necessary for the applicant to ensure the suitability of the measuring instruments for use or in case of damage to the verification mark and/or loss of the verification certificate.

Expert verification is conducted in the event of disputes regarding metrological characteristics, suitability for application, and the correctness of the operation of the measuring instruments.

Inspection verification is carried out during the exercise of metrological supervision, especially within the framework of scheduled and unscheduled checks by the market surveillance authority.

Time for verification.
According to Order No. 1719, standards of time are established, necessary for the verification of legislatively regulated measuring instruments in operation. Verification should last several days and must not exceed 15 working days after submitting the measuring instruments for verification and in case of payment for its conduct in accordance with the provision of item 12 of section II of Order No. 193.

What are the consequences for not conducting periodic verifications?
In this section, we will consider the responsibility for conducting periodic verifications of medical devices with a measuring function and its implications.

Obligation to conduct periodic verifications.
According to item 13 of Resolution No. 285 “On Approval of Licensing Conditions for Medical Practice”, business entities that have a medical practice license are obliged to conduct periodic verifications of medical devices with a measuring function in use on time, observing established intervals between verifications. This provides a legal basis for periodic verifications after the introduction of such products into operation.

Liability for non-compliance with the obligation.
Article 16 of the Law “On Licensing Types of Economic Activities” states that a breach of license conditions, which includes the obligation to conduct periodic verifications, may lead to the suspension or cancellation of a medical practice license.

Liability for not conducting periodic verifications.
Administrative liability.
The obligation to conduct periodic verifications of medical devices with a measuring function during their operation is vested in healthcare institutions (end consumers) and their officials. For violating this obligation, liable individuals can face penalties in the form of fines based on Article 1711 of the Administrative Offenses Code of Ukraine. This applies to officials of both enterprises and organizations, regardless of ownership form, as well as individual entrepreneurs.

Criminal liability.
In cases where the failure to fulfill the obligation to conduct periodic verifications of medical devices results in negative consequences, including threats to human life and health, criminal liability may arise in accordance with Article 367 of the Criminal Code of Ukraine (official negligence).
Since periodic verification is defined as mandatory for medical devices after their commissioning, the responsibility described above relates to issues associated with conducting these verifications during the operation of the products. This means that officials of health care institutions (end consumers) bear the risk of being held responsible for non-compliance and/or improper performance of this duty. It should be noted that since Article 367 of the Criminal Code of Ukraine establishes responsibility for non-performance or improper performance of official duties, under certain conditions, liability can also arise for not carrying out an extraordinary verification if it was not conducted before the introduction of the medical devices into operation and caused significant damage.

How are the results of the verification formalized?
According to clause 2 of section IV of Order №193, the results of the medical devices verification are considered positive if their metrological and technical characteristics meet the requirements of the Law of Ukraine “On Metrology and Metrological Activity” and technical regulations.

Positive results of periodic, extraordinary verifications, and verifications after repairs of medical devices are certified by a verification stamp imprint or a record with a verification stamp imprint in the relevant section of operational documents and/or are formalized with a certificate of verification of medical devices.

It is important to note that according to Article 30 of the Law, in the presence of relevant international agreements, Ukraine recognizes the results of conformity assessment, verification, and calibration of measuring instruments conducted in other countries.

For the purposes of verification, only those documents defined by the legislation of Ukraine that confirm compliance and verification results of medical devices have legal force.

The formalization of the results of verification of medical devices is an essential component of their use in practice and ensures compliance with metrological requirements and standards.

What are the additional features?
If the measurement results are obtained in digital value, they should be indicated in standard units of measurement (International System of Units SI) according to the Classification system for denoting units of measurement and accounting.

Conclusion:
Medical devices with a measurement function are subject to metrological legislation. Medical devices were excluded from the Technical Regulation No. 94 of legislatively regulated measuring instruments, but the manufacturer must ensure and declare accuracy, quality, and compliance with requirements at the time of introduction into circulation and operation.
The initial verification was canceled in 2019, but an extraordinary verification may be required when introduced into circulation after prolonged storage.
All other types of verifications applied to medical devices in operation, including – periodic verification, which should be carried out at intervals once a year for most medical devices. Verifications must be carried out by the healthcare institution in which the medical device is in operation, and violation of these requirements can lead to the loss of a license, administrative, and criminal liability.

Maksym Bagrieiev, Managing Partner

Victoria Moroz, Key Account Manager

Maxim Lovkin, Legal Advisor