Declaration of medical equipment

Declaration of medical equipment

What we do

  • we help to determine whether the product is medical and, if so, which class it belongs to;
  • identify devices, declaration  of which  can be carried out according to a simplified procedure (for example, self-declaration or recognition of certificates issued in EU countries);
  • we help verify the compliance of medical devices with the Technical Regulations, including by means of an audit of the quality management (control) system.

OUR FEES

Declaration of medical equipment
Negotiated

The cost depends on a number of factors, including the procedure by which compliance verification will be carried out:

  • management quality audit;
  • recognition of already issued certificates in EU countries;
  • tests of a batch of medical products;
  • self-declaration.

WHY CHOOSE US

  • plus

    TRIED-AND-TESTED CONTACTS WITH COMPLIANCE VERIFICATION BODIES

    Having worked in the medical industry for a long time, our company has formed partnerships with bodies accredited to conduct verification of the compliance of medical devices, quality management systems, etc.
  • plus

    ENGLISH-SPEAKING EMPLOYEES SUPPORTING PROJECTS

    Since in most cases our company deals with foreign manufacturers of medical devices, we understand how important high-quality communication is both at the organizational stage and during the verification process. That is why work with the client is carried out by English-speaking client managers and lawyers.

ANY QUESTIONS LEFT?

Our lawyers will advise you!

Ask a lawyer

Documents

  • Findings of a medical device clinical evaluation
  • Quality manual
  • Draft labels and instructions for use

Since various procedures can be used to verify compliance, and also because of the existence of separate regulations for different types of products, the documents may differ from product to product.

REFERENCES FROM OUR CLIENTS

L. Chervonyuk, LLC "Vitalux"

Vitalux company highly appreciates results of cooperation with Law firm “Pravova dopomoga”, can characterize it as a reliable partner and based on personal experience is ready to recommend it to interested persons...... More information

General Manager Stashkevych I.Y., LLC “Trading company” Rud”

We would like to indicate that law firm "Pravova Dopomoga" has become a reliable partner for legal services provision and we can recommend it as a team of qualified professionals who are easy and pleasant to deal with... More information

Chief ophthalmologist of Ukraine, Oksana Vitovska, All-Ukrainian alliance of ophthalmologists

We would like to express sincere gratitute to the team of Law firm "Pravova dopomoga" and personally to Volodymyr Gurlov for professionalism and purposefulness in your work.... More information

President Tedeev E.S., Ukrainian wrestling association

Ukrainian wrestling association would like to express its sincere appreciation to the team of Law firm "Pravova Dopomoga" for mutually beneficial cooperation... More information

General director I.Logvinenko , Bravo Airways

Bravo Airways company expresses its gratitude to law firm "Pravova Dopomoga" for high quality and timely provision of legal services.
... More information

Partner, Denis Y. Lysenko, Vasil Kisil & Partners

... we would like to express our respect and gratitude for the fruitful cooperation.
... our work on joint projects assured us of your high level of professionalism
... More information

General director Skibinskiy V., Yokogawa Electric Ukraine Ltd.

Yokogawa Electric Ukraine Ltd. recommends Vladimir Gurlov and his team of lawyers as a reliable legal partner and advisor for foreign businesses in Ukraine...... More information

Important to know

Time period for compliance verification

Time period for the provision of services is determined on an individual case-by-case basis  according to the compliance verification program.

ANSWERS TO FAQs

Is it always necessary to involve an accredited organization for compliance verification?
No, it is not. In case of declaration of medical devices belonging to the first class as per Regulation No. 753 and products that are not included in the list “A” and “B” and are not intended for self-monitoring and / or evaluation of characteristics as per Regulation No. 754, a self-declaration procedure is possible, in which case involvement of a third-party is not required.
Is it possible to certify a medical device without an on-site audit of manufacturing facilities?
Yes, it is. In this case, you can apply the certification procedure for the whole batch or even individual products. You need to understand that this procedure is impractical with the ongoing pruduction, since the procedure will need to be carried out for each individual batch. In addition, when it comes to sterile equipment, this procedure is not applied at all.

SWIFT OBTAINMENT
AND BEST QUALITY PROVEN BY YEARS OF PRACTICE!

Volodymyr Gurlov, Managing partner

Volodymyr Gurlov, Managing partner

RELEVANT INFORMATION

Compliance verification options

1) In the order of the audit of the quality management system (quality management system, QMS) An audit of the quality system allows you to obtain a certificate of compliance for up to 5 years. Although the certificate is issued for such a long period, the current regulation of this area requires conducting            walk-through audits on an annual basis.

 

The audit procedure for the quality management system at the enterprise involves two main
  • verification of the documents of the enterprise by an accredited organization and work with comments from the organization (if any);
  • field audit and assessment of the manufacturing facilities, which is carried out by auditors of an accredited organization in the amount of at least 2 people.
Although the QMS audit is a relatively complex procedure, it is considered the best option for manufacturers planning  to have an ongoing production of this or that item in large quantities.

 

2) Through recognition of foreign EU certificates

 

Recognition of certificates is the best option for foreign manufacturers of medical products who plan to enter them into the Ukrainian market.

 

Key terms that all parties involved in the process must meet are:

 

  • the foreign authority issuing the certificate is accredited in accordance with the requirements of the relevant directives;
  • The Ukrainian certification body has an agreement on the recognition of the verification results with foreign bodies that issued a certificate.
Ukrainian certification bodies are constantly signing new agreements on the recognition of verification results, and therefore, even if at the moment there is no such agreement, the opportunity for recognition may appear over time.

 

3) By testing individual batches (individual product items)

 

Tests of individual batches cannot be called the best option for most manufacturers, however, in some cases, it is practical, for example with:

 

  • the need to quickly bring certain products into circulation;
  • the products are of little use but expensive enough for the feasibility of single-piece declaration.
In accordance with the legislation governing the certification of medical devices, this method cannot be used for sterile equipment. In the case of sterile products, it is necessary to undergo an audit of the quality management system, including an audit at manufacturing facilities.

 

4) Self-declaration

 

You can declare medical devices yourself if they are:

 

  • medical devices that Regulation No. 753 classifies as belonging to the first class;
  • medical devices that Regulation No. 754 does classify as belonging to A list and B list, and which are not used for self-monitoring / evaluation of characteristics.
For these products, a declaration can be prepared independently with subsequent submission to the State Service.

 

Declaration of medical equipment in Ukraine

 

Regardless of the form of certification, a mandatory first step for foreign manufacturers is the appointment of an authorized representative in Ukraine.

 

Our company can help you at any stage of the process.



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