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The new guidance from the European Medical Device Coordination Group (MDCG) covers borderline products not easily categorized as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.
In addition, the MDCG guidance includes additional references and resources to support manufacturers in determining whether their borderline product qualify as medical devices or medical products.
See our blog about the Borderline Products Classification in EU here.
BioReg experts can help you to classify your product, build the most viable regulatory strategy and bring the product to the market.
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