Our firm advised a Polish distributor on reclassifying medical devices initially designed for professional use to make them available to general consumers. The aim was to enable the safe use of these products in home settings, requiring compliance with new regulatory standards.
The process necessitated a full product registration to meet the requirements for the new target audience, posing significant administrative and legal challenges. We analyzed EU and domestic regulations and engaged with certification bodies in Poland and abroad
We provided comprehensive assistance in establishing contact with relevant entities, assessing costs, and evaluating the feasibility of the entire process. As a result, the client gained a clear understanding of the requirements and financial implications of entering the consumer market with medical devices, enabling them to make informed decisions about the project’s future direction.
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