Assessment of Conformity to the Technical Regulations

ECOHYNTOX CAB assesses conformity of medical devices, active implantable devices and medical devices for in vitro diagnostics in accordance with the requirements established by respective technical regulations under the management system procedure, P.9.3.03 Assessment of Conformity to Technical Regulations (download).

The scheme for assessing conformity of medical devices can be found in the table:

Conformity Assessment Scheme Procedure
Scheme A Internal Control over Production of Medical Devices
Scheme B Type Check
Scheme D Assurance of Operation of the Quality Management System in Production of Medical Devices
Scheme E Assurance of Operation of the Product Quality Management System
Scheme F Product Check
Scheme H Procedure for Assurance of Operation of the Comprehensive Quality Management System

According to the requirements of DSTU 4388:2005 and Appendix 2 of the Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2013, medical devices are classified depending on the potential risk of their application.

When it comes to medical devices that do not pertain to the ones produced to order or intended for clinical studies, conformity assessment schemes are applied at the manufacturer’s choice, in accordance with the Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2013:

Medical devices Conformity assessment
Pertaining to Class III Appendix 3 (Scheme Н) with design study
or Appendix 4 (Scheme В)
in combination with Appendix 5 (Scheme F)
or Appendix 4 (Scheme В)
in combination with Appendix 6 (Scheme D)
Pertaining to Class IIb Appendix 3 (Scheme Н) without construction study
or Appendix 4 (Scheme В)
in combination with Appendix 5 (Scheme F)
or Appendix 4 (Scheme В)
in combination with Appendix 6 (Scheme D)
Pertaining to Class IIa Appendix 3 (Scheme Н) without design study
or Appendix 8 (Scheme A)
in combination with Appendix 5 (Scheme F)
or Appendix 8 (Scheme A)
in combination with Appendix 6 (Scheme D)
or Appendix 8 (Scheme A)
in combination with Appendix 7 (Scheme E)
Pertaining to Class I Appendix 8 (Scheme А)
Pertaining to Class I (aseptic) Appendix 3 (Scheme Н) without design study
or Appendix 8 (Scheme A)
in combination with Appendix 5 (Scheme F)
or Appendix 8 (Scheme A)
in combination with Appendix 6 (Scheme D)

According to the requirements of Appendix 2 of the Technical Regulations on Medical Devices for In Vitro Diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02.10.2013, medical devices for in vitro diagnostics are classified subject to List А and List В.

When it comes to medical devices for in vitro diagnostics, the following conformity assessment schemes are used at the manufacturer’s discretion, in accordance with the Technical Regulations on Medical Devices for In Vitro Diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02.10.2013:

Medical devices Conformity assessment
For in vitro diagnostics (except for devices under Lists A and B and devices for assessment of characteristics) Appendix 3 (Scheme А)
Devices for self-control (except for devices for measuring the blood sugar level – Appendix 2, and devices for assessment of characteristics) Appendix 3 (Scheme A) with design study
or Appendix 4 (Scheme H)
or Appendix 5 (Scheme В)
in combination with Appendix 6 (Scheme F)
or Appendix 5 (Scheme В)  
in combination with Appendix 7 (Scheme D)
Devices included into List A, except for devices for assessment of characteristics Appendix 4 (Scheme H)
or Appendix 5 (Scheme В)  
in combination with Appendix 7 (Scheme D)
Devices included into List B, except for devices for assessment of characteristics
 
 Appendix 4 (Scheme H)
or Appendix 5 (Scheme В)  
in combination with Appendix 6 (Scheme F)
or Appendix 5 (Scheme В)  
in combination with Appendix 7 (Scheme D)

When it comes to active implantable medical devices, the following conformity assessment schemes are used at the manufacturer’s discretion, in accordance with the Technical Regulations on Active Implantable Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 755 dated 02.10.2013:

Active medical devices (except for devices produced to order or designated for clinical studies) Conformity assessment
Appendix 2 (Scheme H)
or Appendix 3 (Scheme В) +
in combination with Appendix 4 (Scheme F)
or Appendix 3 (Scheme В)
in combination with Appendix 5 (Scheme D)

Product Conformity Assessment Process (Main Stages)

Scheme A. Internal Control over Production of Medical Devices

Assessment under Scheme A provides for:

  • Submission of the application (download), declaration of conformity, application letter and required documents;
  • Analysis of furnished documents;
  • Report on review of furnished documents;
  • Execution of the certificate of conformity.

Scheme B. Type Check

Assessment under Scheme B provides for:

  • Submission of the application and required documents (download);
  • Expert evaluation of the documents furnished by the manufacturer, check of the device sample in terms of conformity to technical documentation; determination of the elements constructed in accordance with the respective standards which conform to the European harmonised standards, and voluntary application of which may be perceived as evidence of conformity of devices to the Technical Regulations, as well as recognition of elements constructed without application of respective provisions of the given standards;
  • Carrying out or assurance of respective checks and tests necessary to find out whether the decisions taken by the manufacturer conform to the Technical Regulations if the manufacturer has filed to apply national standards which conform to the European harmonised standards, and voluntary application of which may be perceived as evidence of conformity of devices to the Technical Regulations;
  • Carrying out or assurance of respective checks and tests necessary to find out whether respective standards chosen by the manufacturer for application have been applied;
  • Approval of the place of the given checks and tests by the applicant;
  • Issue of the type check certificate.

Scheme D. Assurance of Operation of the Quality Management System in Production of Medical Devices

Assessment under Scheme D provides for:

  • Submission of the application (download) and required documentation (information on respective products; on operation of the quality management system; technical documentation on the checked product type, and copy of the product type check certificate (except for Class IIa));
  • Expert evaluation of technical documentation;
  • Audit of the quality management system;
  • Decision on the possibility of issue of the certificate for the product and quality management system;
  • Technical supervision.

Scheme E. Assurance of Operation of the Product Quality Management System

Assessment under Scheme E provides for:

  • Submission of the application (download) and required documentation (information on respective products; on operation of the quality management system; technical documentation on the checked product type, and copy of the product type check certificate (except for Class IIa));
  • Expert evaluation of furnished documentation;
  • Assessment of the quality management system to establish its conformity to the established requirements;
  • Decision on the possibility of issue of the certificate of conformity to the technical regulations and for the quality management system;
  • Technical supervision.

Scheme F. Product Check

Assessment under Scheme F provides for:

  • Submission of the application (download) and required documentation (information on respective products; technical documentation on the checked product type, and copy of the product type check certificate (except for Class IIa));
  • Expert evaluation of technical documentation;
  • Approval of the place of the studies and tests by the customer;
  • Carrying out or organisation of sample drawing and identification;
  • Organisation of tests;
  • Decision on the possibility of issue of the product conformity certificate.

Scheme H. Procedure for Assurance of Operation of the Comprehensive Quality Management System

Assessment under Scheme H provides for:

  • Submission of the application (download) for conformity assessment, application for certification of the quality management system and required documentation;
  • Expert evaluation of technical documentation and documentation pertaining to the quality management system;
  • Audit of the quality management system;
  • Decision on the possibility of issue of the certificate of conformity and for the quality management system;
  • Supervision.

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