Conformity assessment of medical devices

The manufacturer must notify the authorized body in advance of any planned significant changes in the list of products or their safety, changes in the quality management system. The decision on the necessary actions to approve such changes will be made by the authorized body.

After receiving the Certificate of Conformity, a Declaration of Conformity is drawn up, which is used at customs and accompanies the goods in circulation. 

We offer a range of services that allows you to minimize financial costs and certification time: 

We organize the conformity assessment procedure approved by  Technical regulations in the authorized bodies. 

We conduct an examination of the dossier and issue a declaration of conformity. 

We conduct clinical trials, specialized evaluation of clinical data. 

We are developing a bilingual (Ukrainian-English) Agreement on the Authorized Representative in Ukraine. 

We translate the necessary documents. 

We compile the Technical file in accordance with the requirements of the relevant Technical Regulations. 

We choose the Authorized body for conformity assessment, submit documents, pay for the work of the authorized body, pass the procedure of examination of documentation, respond to comments, agree on objects, dates and inspection plan. 

We organize a visit of inspectors to the production. We develop a draft labeling. We draw up a Declaration of Conformity with the requirements of Technical Regulations.

The list of documents submitted for the assessment of conformity to the requirements of the Technical Regulations. 
✔ Power of attorney of the manufacturer to the authorized representative
✔ List of medical devices for conformity assessment
✔ Certificates of conformity of the manufacturer:

1. Certificate of compliance of the quality system with the requirements of EN ISO 13485.
2. Technical file on MV.
3. Product description.
5. Product classification.
6. Specification for the product.
7. Specification for materials and components.
8. Labels (primary and secondary packaging).
9. List of applicable standards.
10. Risk analysis.
11. Confirmation of compliance with the basic requirements ("checklist").
12. Process diagrams.
13. Information on packaging.
14. Confirmation of conformity of measurement accuracy (if applicable).
15. Declaration of conformity of the MV with the requirements of the Directive.
16. Instructions for use of MV.
17. Report on preclinical studies (evaluation).
18. Report on clinical trials.
19. Quality guidelines.

Conformity assessment with the involvement of the authorized body provides a choice of two options:
By assessing the quality management system of the production site (inspection), resulting in the issuance of a certificate of conformity assessment for a medical device for a period of 5 years, associated with a certificate for a quality management system for a period of 3 years. By batch conformity assessment, which provides for the issuance of a certificate for a specific batch (supply) of medical devices as a result of examination of documentation and testing of product samples.

Medical products, that have undergone state registration, are included into the state register of medical equipment and medical products and is approved for use on the territory of Ukraine, the validity of the certificate on state registration of which is restricted or ends after July 1, 2015 – it is possible to deliver on the registration certificate until 01 July, 2017. Product certification is the conformity process of product quality standards, established by the legislation requirements in Ukraine. Certification is carried by specifically accredited organizations. Supporting documents are issued on the results of certification – certificates of conformity, declaration of conformity.

To obtain a certificate of conformity assessment for a period of 5 years it is necessary to:

✔ Obtain an authorized representative of the manufacturer in Ukraine, to perform all related legal formalities. 
✔ Choose a combination of procedures, according to class, manufacturer’s documentation, and other factors. 
✔ • Form a technical file as required by the relevant regulations; prepare the application form and a check-list. 
✔ Select the authorized body for conformity assessment and to apply, pay for the work of the authority. 
✔ Undergo the documentation expertise procedure to respond to the comments. Finalize the object, date and plan of the inspection. 
✔ Organize inspectors visit on production. 
✔ Eliminate the comments received as a result of the inspection. 
✔ Get a decree of the regulatory body on the quality management system of the production site. 
✔ Get a certificate of conformity assessment of the medical product requirements of the Technical Regulations. 
✔ Issue a declaration of conformity with the Technical Regulations. 
✔ Apply conformity mark and the identification number of the regulatory body to the labeling of the medical product; make sure that the other requirements for labeling and instructions (user manual) comply with the requirements of the Technical Regulations and the currents legislation.

Declaration of conformity replaces the registration certificate at the customs clearance of medical products.

There is no such list as a separate document. However, technical regulations divide medical devices into classes according to the level of potential risk to the patient. According to the class, some medical devices are subject to a mandatory self-declaration procedure, and the rest are subject to the requirements for involvement of the designated conformity assessment bodies in conformity assessment for placing on the market in Ukraine.