Certification in the EU
To enter the European market, it is necessary to comply with the European Regulation MDR (Medical Device Regulation) 2017/745. Unlike Ukrainian technical regulations, MDR includes a number of additional requirements that must be implemented to enter the European market. Specifically, you need to register in the EUDAMED electronic database, implement a UDI labeling system, structure clinical evaluations and risk assessments, and establish a post-marketing surveillance system.
In general, the approximate plan for entering the European market is as follows:
- familiarize yourself with the MDR requirements and conduct training for staff
- appoint a person responsible for regulatory compliance within the company (must have at least 2 years of experience in medical device manufacturing and/or quality management systems)
- conduct an internal audit for compliance with Regulation 2017/745
- address identified non-compliances and update the technical file
- appoint an authorized representative in the EU
- register in the EUDAMED database
- find a suitable notified body
- submit an application and undergo certification
Typically, the certification process with a European notified body takes about a year. For low-risk medical devices (Class I), involvement of a notified body is not required; registration is done through the EUDAMED database and interaction with a local competent authority (analogous to the State Drug Administration).
Med Quality helps clients meet the requirements of MDR 2017/745 to provide European consumers with high-quality Ukrainian medical devices and to assist Ukrainian companies in entering the European market and expanding their sales channels. The company’s experience enables us to quickly identify and address weaknesses in the quality system and prepare a technical file for medical devices considering all possible MDR requirements. We assist in staff training and selecting a notified body to ensure not only the fastest but also the highest quality path to the European market.
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