Since September 4, 2016, the Technical Regulations for legally regulated Measuring Instruments have come into force (Resolution of The Cabinet of Ministers of Ukraine No. 94 of January 13, 2016). This Technical Regulation sets up the requirement to conduct mandatory conformity assessment and apply the appropriate marking prior to putting products into use (operation). This Technical Regulation is not based on any EU Directive.
Appendix 1 to the Technical Regulations for legally regulated Measuring Instruments includes the following medical devices:
• Blood pressure meters,
• Blood alcohol level meters and expired alcohol level meters,
• Refractometers, ophthalmometers,
• Medical thermometers,
• Patient monitors,
• Non-automatic measuring devices,
• Medical piston dosing devices,
• Pulse oximeters,
• Ultrasonic diagnostic devices,
And medical devices for in-vitro diagnostics:
• Analyzers for medical use:
- blood electrolytes and gases;
• Medical pipetting dosing devices;
• Conductometers, pH-meters, titrators and ionometers for use in medical laboratories;
• Gas and liquid chromatographs.
It is worth noting that medical devices not mentioned above but including measuring equipment as accessories or sub-assemblies are also subject to conformity assessment to Technical Regulation No. 94. For example, the following medical devices often include a patient monitor as an integral part or an optional accessory:
• Devices for artificial ventilation (DAL);
• Anesthesia and respiratory devices;
• Dialysis machines;
• Incubators for newborns;
Thus, the above products fall under the simultaneous operation of two technical regulations:
• for medical devices: Regulation No. 753 and Regulation No. 94;
• for medical devices for in-vitro diagnostics: Regulation No. 754 and Regulation No. 94.
The designated bodies for conformity assessment, procedures (Modules), marking requirements and other requirements of the Technical Regulations for legally regulated measuring instruments differ significantly from the provisions of the "medical" Technical Regulations.
Conformity of measuring instruments with Technical regulations must be certified by applying a sign of conformity and additional metrological marking on them.
Additional metrological marking should consist of the sign of a legally regulated measuring instrument and the last two digits of the year of its application, surrounded by a rectangle.
Additional metrological marking must follow after the sign of conformity.
The company "Cratia" offers the execution of works on the assessment of conformity with the requirements of the Technical Regulations for the legally regulated measuring instrument (approved by Resolution of CMU № 94 of January 13, 2016). We have the necessary knowledge, experience and skills to carry out all necessary work. We will take the lead and process arrangement; we will help to conduct the procedure in a short time.
We are fluent in English, and if necessary we are ready to communicate with the manufacturer directly.
• All necessary consultations regarding the requirements of the Technical Regulations, possible procedures for assessing compliance;
• Professional examination of documentation;
• Filing of technical documentation, filling in the check-list (essential requirements);
• We perform all works for the Application submition and conformity assessment conduction according to the chosen procedure (Modules) on the basis of the Power of Attorney;
• Development of the Declaration of Conformity to the requirements of the Technical Regulations
• Design of a package marking project and instructions (user manuals);