The European Commission has published the Final Summary Report of its Targeted Evaluation of the EU Medical Devices and In Vitro Diagnostic Regulations (MDR/IVDR).
Early analysis by MedTech Europe has shown the following:
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Reforms should prioritise simplification, a risk-based and proportionate approach, and clearer guidance to enhance implementation.
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There is support for harmonised EU regulations; however, compliance costs remain high, posing significant challenges, particularly for SMEs.
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Both regulatory frameworks are perceived as barriers to innovation, with the IVDR attracting greater concern.
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While the goal of enhancing patient safety is widely acknowledged, its implementation is seen as overly burdensome and inconsistently applied.
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Sustainability and environmental impacts are largely overlooked in both sets of regulations.
You can find the report here. You can share your feedback with regulatory@bivda.org.uk who will pass it on to MedTech Europe.
