Recognition of EU certificate of Ukraine

Consulting Service Plus offers professional services for the recognition of certificates of conformity issued in Ukraine for use in the European Union. This is an important step for manufacturers of medical devices, disinfectants and cosmetic products who plan to introduce their products to the EU market in accordance with the requirements of Regulation (EU) 2017/745 (MDR) and other regulations.

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Certificates are recognised by the following notification bodies:

Certificates of conformity issued in Ukraine may be recognised by notification bodies accredited in the European Union, which are responsible for assessing the conformity of products with Regulation (EU) 2017/745 (MDR) or other EU regulations.

TÜV SÜD Product Service GmbH (Germany) – code 0123

DEKRA Certification GmbH (Germany) – code 0124

BSI Group The Netherlands B.V. (Netherlands) – code 2797

GMED SAS (France) – code 0459

SGS Belgium NV (Belgium) – code 1639

National Standards Authority of Ireland (NSAI) (Ireland) – code 0050

IMQ S.p.A. (Italy) – code 0051

Intertek Semko AB (Sweden) – code 2862

Polskie Centrum Badań i Certyfikacji S.A. (Poland) – code 1434

TÜV Rheinland LGA Products GmbH (Germany) – code 0197

Eurofins Product Testing Italy Srl (Italy) – code 0477

HTCert (Cyprus) – code 2803

ITALCERT Srl (Italy) – code 0426

Kiwa Cermet Italia S.p.A. (Italy) – code 0476

UDEM Adriatic d.o.o. (Croatia) – code 2696

SZUTEST (Turkey) – code 2975

What is EU recognition of Ukrainian certificate?

Certificate recognition is a procedure of adapting the certificate of conformity issued in Ukraine to the norms of the European Union. It allows to confirm that the products meet European standards of safety, quality and efficiency.

The service is relevant for companies that:

✔ seek to enter the European Union market;

✔ want to minimise time and money spent on certification;

✔ plan to confirm the conformity of their products without the need for additional audits in production.

Advantages of certificate recognition with Consulting Service Plus

1.Avoiding audits at the production site.

The procedure avoids additional audits at production facilities, which greatly simplifies the process.

2.Time saving.

The use of already existing certificate in Ukraine significantly accelerates the entry into the EU market.

3.Guarantee of conformity.

A certificate recognised in the EU confirms the compliance of products with the requirements of Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR).

4.Minimise costs.

You save on additional testing, audits and the development of new documents.

5.Professional support.

Our team provides a full range of services: from analysing documentation to liaising with European notification authorities.

Legislative basis of the recognition procedure

The procedure is based on:

1.European legislation:

✔Regulation (EU) 2017/745 (MDR) — regulates medical devices;

✔Regulation (EU) 2017/746 (IVDR) — for in vitro medical diagnostic products;

✔Directives 93/42/EEC and 90/385/EEC, which apply during the transition period.

2.Ukrainian legislation:

✔ CMU Resolutions No. 753, No. 754, No. 755 vid 02.10.2013 - regulate requirements for medical devices;

✔ Law of Ukraine ‘On Technical Regulations and Conformity Assessment’ (No. 124-VIII of 15.01.2015).

3.International standards:

✔ ISO 13485 — quality management systems for medical devices;

✔ ISO 14971 — risk management.

Stages of certificate recognition

1. Analysing the existing certificate.

We check the certificate of conformity for compliance with European standards, including MDR.

2.Preparation of the technical dossier.

Formation of a package of documents including:

✔ technical description of the product;

✔ clinical report or evidence of safety and efficacy;

✔ test reports;

✔ ISO 13485 certificate.

3.Transmission of documents to the EU notification body.

We liaise with the European authorities to verify and harmonise the certificate.

4.Receipt of validation.

After successful verification, your certificate is recognised in the EU, allowing you to start selling your products.

Documents required for the recognition procedure

✔ Certificate of conformity issued in Europe;

✔ Technical documentation for the product;

✔ Clinical data and evidence of efficacy;

✔ ISO 13485 certificate;

✔ Test reports and declaration of conformity.

Why choose Consulting Service Plus?

✔ Expert approach.

✔ Time and cost savings.

✔ Professional support.

✔ Guaranteed result.

Ready to have your certificate recognised in the EU?

Entrust this process to professionals! We will ensure fast and efficient certificate recognition of your products, guaranteeing their compliance with EU standards.

Contact CSPlus today to start the recognition process and open new markets for your products!

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.

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.