The legal framework for medical devices is determined in the EU by the Medical Devices Directive 93/42/EEC (MDD). This divides medical devices – based on their hazard potential – into four classes (I, II a, II b, III). We advise you with the classification and assist in compiling the technical and regulatory documentation. The classification of your "borderline products" is also in good hands with our specialists.
With our subsidiaries and partners we are in a position to open up the global market for worldwide registration of your products.
Our experts and specialists worldwide can help with your individual queries related to medical devices. Get in touch!