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March 2022

Why regulatory strategy is essential for startup managers

Knowledge & Resources /

Medical device startups are mainly combining latest technologies (i.e., interconnectivity of medical devices, software and machine learning diagnosis with the help of Big Data). In doing so they demand highly skilled resources in each field of it. EUMEDIQ is often asked by startups for support in regulatory consulting during design & development stages. The experience […]

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The MDR approach on substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’)

Knowledge & Resources /

One of the big changes in EU MDR 2017/745 in contrast to the MDD are the clear requirements on the handling of substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’). Fortunately, manufacturers are not meant to define by themselves which substances are considered CMR. REGULATION (EC) No 1272/2008, Annex VI, part 3 provides

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