Self-declaration of the Technical Regulations
PE “Consulting service plus” offers services on self-declaration of medical products by Technical Regulations.
Self-declaration procedure by Technical Regulations is applied to:
- I class non-sterile medical products, without measurement functions.
- In-vitro medical products, which are not included in the list of “A” and “B” of the Technical Regulations, which are not intended for self-control
Medical devices that fall under the self-declaration does not necessarily apply to the authorized bodies for conformity assessment. To meet the requirements of Technical Regulations of medical devices it is necessary to:
- Get the power of attorney for the authorized representative of the manufacturer in Ukraine
- Form the Technical File, which includes:
- general description of the medical device, including any planned modifications of the product and its intended use;
- design drawings, information about the methods of production of said medical device, and schemes of components, sub-assemblies, circuits, etc.;
- descriptions and explanations necessary for understanding these drawings, diagrams and operation of the medical device;
- risk analysis results, information on the standards applied in full or in part, from among those included in the list of standards that comply with European harmonized standards and voluntary use of which may be perceived as evidence of compliance of medical devices requirements of the Technical Regulations on medical devices, as well as descriptions of the solutions adopted to meet the requirements of the Technical regulations on medical devices in the event of partial application of these standards;
- results of the design calculations and checks. If the medical product is intended for connection to other medical devices for the purpose of the intended use, provided confirmation of compliance with the requirements of the Technical Regulations on medical devices when connected to other medical products;
- pre-clinical evaluation results;
- clinical evaluation results
- label and instructions for use.
- Make translations of the manufacturer’s documentation into Ukrainian language.
- Make declaration of conformity with the Technical Regulations.
- Make a marking with the conformity mark.
- Submit in the State Service a copy of the manufacturer’s Agreement for the authorized representative, a copy of Declaration, information letter, submit an electronic form.
We offer a range of services that allows minimizing the financial costs and time limits of self-declaration:
- Make a list of necessary documents from the respective Technical Regulations.
- Carry out documentation examination.
- Develop a bilingual (English-Ukrainian) Agreement on Authorized Representative in Ukraine.
- Translate necessary documents.
- Compile the Technical file as required by the Technical Regulations.
- Conduct clinical trials, specialized evaluation of clinical data.
- Organize letters for the customs authorities with proof of medical devices membership.
- Develop a marking project.
- Make Declaration of conformity with the Technical Regulations.
- Submit to the State Service a copy of the Agreement from the manufacturer to the authorized representative, a copy of the Declaration, information letter, and send in an electronic form.
High professionalism of our employees and the company's long experience in the field of registration and licensing of medical products enable us to find the optimal solution for the customer in terms of performance and costs, as we have our own accredited centers, laboratories and hospitals.
We look forward to collaborating!