- 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.
