info@propravo.ua 
Medical Device Compliance Assessment
We assist you in completing all necessary procedures to confirm the compliance of medical devices.
- Determination of the required type of conformity assessment.
- Analysis of Technical Regulations and regulatory documentation requirements.
- Consultation on the preparation of the technical file and other required documents.
- Support for certification procedures and obtaining a declaration of conformity.
- Interaction with conformity assessment bodies and regulatory authorities.
Key Steps for Medical Device Certification
We provide full legal and consulting support throughout the certification process.
- Determination of the required certification type according to the product’s risk class.
- Analysis of regulatory requirements and preparation of necessary documentation.
- Organization and supervision of product testing in accredited laboratories.
- Interaction with certification bodies and regulatory authorities.
- Obtaining the certificate of conformity and recommendations for further use.
Self-Declaration and Registration
We assist manufacturers and suppliers in completing the self-declaration and registration process for medical devices.
- Determination of the risk class and the necessary conformity assessment procedure.
- Preparation of declaration of conformity and technical documentation.
- Consultation on product labeling and affixing the conformity mark.
- Registration of medical devices in the official state registries.
- Interaction with regulatory authorities to confirm compliance.
Manufacturing Audit
We conduct a comprehensive audit of manufacturing facilities to verify compliance with Technical Regulations.
- Analysis of the manufacturer’s quality management system in accordance with ISO 13485.
- Verification of production processes for certification compliance.
- Evaluation of technical documentation and manufacturing premises.
- Preparation for inspection by conformity assessment bodies.
- Recommendations for eliminating non-conformities.
Batch Certification of Medical Devices
We assist in obtaining a certificate of conformity for a specific batch of medical devices to enable their legal import, distribution, and use in Ukraine.
- Determination of the required certification procedure under Technical Regulations.
- Preparation and submission of documents for batch certification.
- Organization of testing in accredited laboratories (if required).
- Interaction with conformity assessment bodies and regulatory structures.
- Obtaining a certificate of conformity for the specific batch of products.
Recognition of CE Certification in Ukraine
We facilitate the official recognition of CE certification (EU certificates) in Ukraine.
- Analysis of the existing EU certificate and verification of its compliance with Ukrainian regulations.
- Preparation and submission of documents for official recognition.
- Interaction with conformity assessment bodies and regulatory authorities.
- Issuance of a declaration of conformity and affixing of necessary.
- Consultation on further registration and market introduction.
Authorized Representative of the Manufacturer.
We provide official representation services for foreign medical device manufacturers in Ukraine.
- Representation of the manufacturer’s interests before Ukrainian regulatory authorities.
- Preparation and submission of required documentation for medical device registration.
- Interaction with conformity assessment bodies and certification institutions.
- Control over product compliance with Ukrainian Technical Regulations.
- Support for market introduction and further product distribution.
Development of Technical Documentation
We assist in preparing a complete set of technical documentation to ensure medical devices comply with legislation and successfully pass certification.
- Preparation of the technical file in accordance with Technical Regulations.
- Development of user manuals, labels, and product markings.
- Creation of the declaration of conformity and risk assessment.
- Documentation formatting in compliance with ISO 13485.
- Interaction with conformity assessment bodies and certification authorities.
Recently Obtained Certificates
FAQ – Frequently Asked Questions
All medical devices placed on the market or used in Ukraine must comply with the requirements of Technical Regulations approved by resolutions of the Cabinet of Ministers of Ukraine.
This is the process of confirming that a medical device meets the Technical Regulations. It includes various procedures such as self-declaration, certification through conformity assessment bodies, and manufacturing audits.
Yes, but they must go through the recognition procedure to ensure compliance with Ukrainian legislation.
Self-declaration is a procedure where the manufacturer independently confirms compliance without involving a conformity assessment body. It applies to Class I (low-risk) devices.
A contract must be signed with the manufacturer, a power of attorney must be obtained, and the required documents must be submitted to a conformity assessment body for registration.
