Medical device labelling: key rules and ISO standards
Advantages of working with us
Reliability
Professional experience of the company with a team of highly qualified specialists in their field. We combine our knowledge and experience, use connections and contacts in the field of medical products certification since 2003.
Work without intermediaries
Our specialists are directly involved in the preparation of all documents and interaction with the relevant state authorities.
Guarantees
We guarantee the result of timely provision of services and cost. Compliance with the principles of confidentiality when working with clients. Rich experience allows us to solve problems and find solutions in any situation.
Short terms of work execution
Prompt execution of documents.
We control the timing of work and the correctness of documents at all stages. An integrated approach.
2003
Year of foundation
420
Regular customers
35
International partners
Our clients
We offer a whole range of services that allows you to minimize financial costs and terms of self-declaration:
✔ We compile a list of necessary documents from the relevant Technical Regulations.
✔ We carry out examination of documentation.
✔ Developing a bilingual (Ukrainian-English) Agreement on Authorized Representative in Ukraine.
✔ We translate the necessary documents.
✔ We compile the Technical file in accordance with the requirements of the Technical Regulations.
✔ We conduct clinical trials, specialized evaluation of clinical data.
✔ We organize letters for customs authorities with confirmation of belonging to medical devices.
✔ We are developing a labeling project.
✔ We draw up a Declaration of compliance with the requirements of Technical Regulations.
✔ Submit to the State Service a copy of the Agreement from the manufacturer for an authorized representative, a copy of the Declaration, an information letter, send an electronic form.
Answers to frequently asked questions
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.