Medical devices in Ukraine must pass an conformity assessment with the Technical Regulations in order to guarantee their safety and operation in accordance with the intended purpose. Authorized bodies for conducting conformity assessment are appointed by the Ministry of Economic Development. Register of Designated Conformity Assessment Bodies (CABs) required by technical regulations
Conformity assessment usually includes an audit of the manufacturer’s quality system and, depending on the type of device, verification of technical documentation on the safety and performance of the product.
Manufacturers may affix a conformity mark to a medical device after it has passed a conformity assessment.
The following is a step-by-step description of the conformity assessment process for medical devices of I-III risk class.
Determine the classification of your device using Appendix 2 to the Technical Regulation for Medical Devices (TP No. 753): Class I (non-sterile, non-measuring), Class I (sterile, measuring), Class IIa, Class IIb or Class III/AIMD. Active implantable medical devices are generally subject to the same regulatory requirements as class III devices; Appendix 2 to the Technical Regulations for in vitro diagnostic medical devices (TP No. 754).
For all products except class I (non-sterile, non-measuring), implement the Quality Management System (QMS) in accordance with Appendix 3 or 6 to TR No. 753.
Most companies apply the ISO 13485 standard to achieve QMS compliance.
For class I (non-sterile, non-measuring), QMS is not formally required. However, the PMS procedure (post-marketing surveillance) is required, although it is not verified by the conformity assessment body (CAB).
For MD classes I through IIb, prepare a Technical File that contains detailed information about your medical device and demonstrates compliance with TR requirements. All product types will require clinical data. Most of this data should relate to the item.
For class III/AIMD products, prepare a design dossier. Clinical studies are required for class IIb and III implants, although existing data may also be acceptable. Clinical trials in Ukraine must be pre-approved by the competent authority.
If you do not have a representative office in Ukraine, appoint an Authorized Representative (AR). The AR must be qualified and have relevant experience to solve regulatory issues. Place the name and address of the AR in the instructions for use, outer packaging or product label.
For all products except class I (non-sterile, non-measuring), your QMS and the Technical file or project dossier must be checked by the authorized body with the appropriate accreditation.
For all products except class I (non-sterile, non-measuring), you will be issued a certificate of conformity for your product and an ISO 13485 certificate for your organization after a successful audit by an authorized body. ISO 13485 certification must be updated every year.
Prepare a declaration of conformity, a legally binding document prepared by the manufacturer, which indicates that the product complies with the current TR. Now you can affix the mark of conformity .
All Class I products must be registered with the competent authority. Today, this body is the State Service of Ukraine on Medicines and Drugs Control dls.gov.ua
For Class I (non-sterile, non-measuring) annual CAB checks are not required. However, you must update the clinical assessment report and follow the PMS action.
For all other classes, you will be checked annually by the authorized body for compliance with the TR. If you do not pass the audit, your certificate of conformity will become invalid. You must update the clinical evaluation report and follow the PMS action.
This is a simplified overview of the process. The conformity assessment body may request additional documents, which will increase the time for obtaining a certificate.