LLC EXPORT CENTER provides not only assistance in MDR REGULATION (EU) 2017/745 implementation, but also a new regulation requirements training. Our specialists are competent in every respect from regulation distinction and skills of successful application up to the communication ability of information delivery on the subject to any specialist and the ability to achieve the necessary regulations requirements with minimal cost. They can warn you in advance if the standards’ requirements are difficult or impossible to implement in your business.

We don't undertake projects that we can’t get the job done.

We help to implement not only MDR, but also ISO 13485, GMP and other standards. The implementation of these standards will help you if you’re really concerned about the developing new markets.

Here is some general information that you should know in order to make a decision about the MDR implementation requirements or transition from MDD to MDR.

The transition EU MDR period ends in May 2025. So it will be impossible to work in the EU without a certificate in July 2025. The MDD 93/42 certificate must be upgraded by May 2021, but not by the end of the transition period. Not every company will have the opportunity to use it up to 2025, because some of the changes are already critical.

Why do we need a new EU MDR regulation?

MDR REGULATION 2017/745 unifies the rules for medical products in all the EU. The rules had previously differed from country to country that made free trade more difficult.

What is the MDR aimed at:

The regulations implementation can be divided into 10 steps in a particular organization:

  • 1. Medical device definition of the use scope and its classification that will affect the further actions. And that’s why it is necessary to take them reasonably and accurately. Especially if the product may have a border medical purpose or other classification depending on the rules comment
  • 2. The necessary determination processes and resources are carried out by using the design, processes, a quality management system and other documents development
  • 3. Risk minimization, general safety verification and performance requirements are fulfilled through the risk management planning, benefits and risk report, market oversight plan
  • 4. Clinical evaluation includes the clinical evaluation plan development, an after-sales clinical observation plan and other documents that depend on the classification and device novelty
  • 5. Drawing up technical documentation - "Unique Device Identifier" (a method of using bar codes in order to track devices wherever they are distributed in the European Union) and other documents including those that were prepared earlier for carrying out the previous steps
  • 6. Drawing up agreements on the medical products distribution – that means compliance with the rules on the information exchange with distributors and/or the appointment of a EU representative with a clear definition of his authority. The EU MDR implies a mandatory legal presence in the EU in order to be able to accept reclamations
  • 7. A manufacturer and the goods registration in the authorized bodies. As a result, you should have a single registration number, UDI data that will be uploaded in EUDAMED and the conformity declaration of the European Union
  • 8. Conformity certificates can be obtained in any authorized body that was accredited for a required product type
  • 9. Verification of all the necessary documentation and beginning of export
  • 10. Current obligations fulfillment according to the MDR requirements after the goods registration, namely:
    • support risk management concept
    • completion of planned after-sales clinical activitie
    • updating of technical documentation
    • improvement of the quality management system, etc.

    • Our experts rework the documentation that you have and accompany the whole process of getting the EU MDR certificate by your company. Our specialists are competent and have professional experience work with foreign and national medical companies. Leonid Belabko is one of them (Lead Auditor IMQ Certification body IMQ S.p.a, LL-C Czech, Quality Austria, PECB Canada) and sales managers that are ready to make the cooperation well-organized and efficient.


LLC EXPORT CENTER options for assistance in the field of certification (part or full range of services):

— information and advisory assistance in choosing the system and country of certification, analysis of your readiness and implementation prospects for your business;;
— development and implementation of quality management and chain of custody systems whatever you have already or haven’t any at all. The whole cooperation will be based on you needs;
— carrying out a preliminary audit, calculate the cost of implementing one of the systems and its certification;
— updating of quality management systems to the requirements of the standards’ latest edition;
— assistance in obtaining the missing required documentation;
— training of your employees according to the standards;
— advising on the selection of a certification body;
— supporting of the certification audit and solving all the arises questions during the process and after it;
— accompanying the process of obtaining a certificate with a guarantee of the result that is specified in the contract.

We united together highly experienced experts, qualified auditors, international certification bodies and got a professional certification support center – called LLC EXPORT CENTER. We guarantee high-quality and efficient implementation of your project, because our experience covers not only all sectors of the economy, but also all countries. All our customers from Belarus, Russia, Estonia, the UK and other countries have received the necessary certificates already, and from our side we guarantee the result for your company.


More than 15 years in the field of certification
Over 150 completed projects
Responsible work approach
Flexible pricing
Certificate Guarantee


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