Clinical trials of medical devices

Consulting Service Plus offers services of clinical evaluation of medical devices - a special study with the participation of people, which is conducted to assess the functionality, effectiveness and safety of the tested product.

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The procedure of clinical trial of medical devices:

Trials are conducted on special accredited bases. Upon completion of clinical trials, the following documents are drawn up: the conclusion of the ethics commission, the program, the protocol, the report.
Clinical trials can be initiated only after encouraging results have been obtained in preclinical studies (studies on biological models and laboratory animals), as well as the approval of the ethics committee and a positive decision of the authorized body to conduct the trials.

Before the start of clinical trials, a log and an act of informed consent of the patient are drawn up.
Informed consent is a process that allows a patient or healthy volunteer to freely confirm their willingness to participate in a clinical trial. The informed consent form is a document that is signed by the trial participants (patient and investigator).
The research doctor informs the patient about all aspects of clinical trials that may affect the decision to participate in the experiment (benefits, risks, time costs, possible side effects, etc.) Therefore, such consent is called informed. After all aspects of participation in the clinical trial are explained to the potential participant, the researcher gives the patient written information describing the details of the study (duration, procedures, risks, potential benefits, etc.). Having carefully studied the document again, the participant decides whether to sign the consent or not.

A trial participant can withdraw from the study at any time without giving any reason.

If the manufacturer of medical devices provides materials of clinical trials conducted earlier, a specialized evaluation of clinical trial materials is performed. Patients do not participate in this study. Experts process the data provided by the manufacturer and draw up a report.

Based on the documents obtained as a result of clinical trials or specialized evaluation of clinical trial materials, the authorized conformity assessment body decides on the conformity of the medical device with the technical regulations or non-compliance.

The company "Consulting Service Plus" has extensive experience in organizing clinical trials (specialized evaluation) of medical devices, so we have direct contracts with accredited centers, laboratories and hospitals.

Clinical report for medical devices

Preparation of a clinical report for medical devices

Consulting Service Plus offers services for the development of clinical reports for medical devices in accordance with the requirements of the current legislation of Ukraine and international standards.

Why do you need a clinical report?

A Clinical Evaluation Report (CER) is a mandatory document that confirms the safety and efficacy of a medical device based on clinical evaluation data.

This report is required for:

- The report is a component of the technical file

- Obtaining a marketing authorisation for a medical device on the Ukrainian market;

- Ensuring compliance with technical regulations, in particular, the Technical Regulations on Medical Devices approved by the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2013;

- Passing the conformity assessment procedure and obtaining a declaration of conformity or certificate;

- Registration of the product in other countries, if required.

Requirements for clinical reports for medical devices in Ukraine

In accordance with the requirements of Ukrainian legislation and EU standards, clinical evaluation of medical devices is carried out in accordance with DSTU EN ISO 14155 and the provisions of Technical Regulation No. 753.

The main stages of clinical report preparation:

1. Collection of data on the medical device, including its design, technical characteristics and purpose.

2. Analysis of available data from the clinical literature, including the results of studies of similar products.

3. Comprehensive analysis of risks and benefits of the product.

4. Preparation of a report in accordance with the requirements of the law.

How do we work?

The specialists of Consulting Service Plus have experience in the field of medical device certification and preparation of clinical reports since 2003.

We offer:

Professional approach. Our experts carefully study the characteristics of the product and all available data.

Comprehensive support. We help to collect and organise the information required to prepare the report.

Compliance with the requirements. Reports are developed in accordance with Ukrainian and international standards, including EU requirements (MDR 2017/745).

Saving time. We organise the process to minimise your time and resources.

What is included in a clinical report?

- Identification of the medical device

- A list of applicable standards for products harmonised with Ukrainian legislation

- List of clinical data sources

- Critical analysis of literature data

- Analysis of risks and benefits of the product.

- Comparison with similar products.

- Clinical trial results or literature review data.

- Conclusions on the product's compliance with safety and efficacy requirements.

Why choose Consulting Service Plus?

Expertise. We specialise in the certification of medical devices and know all the intricacies of regulatory requirements.

Individual approach. Each product and client receives personalised service.

Compliance with international standards. We prepare clinical reports in accordance with the requirements of MDR 2017/745, which is important for working in the EU markets.

Efficiency. We work quickly and efficiently, minimising the risks of certification denial.

What do you get?

- A detailed clinical report analysing the safety and efficacy of the product.

- Documentation ready for submission to the conformity assessment bodies.

- Consultations on all stages of certification.

Contact Consulting Service Plus!

We will help you to prepare a clinical report that will become a reliable basis for certification of your medical device in Ukraine and on the international market.

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

Answers to frequently asked questions

What documents are required for certification?

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.

Validity of certificates?

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.

What is the difference between registration and certification?

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.

What are the stages of the certification procedure?

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.

What you get after all the certification procedures?

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

Is there a specific list of medical devices subject to mandatory certification?

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.