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EU MDR: Medtechs Must Look At The Bigger Picture Of Regulatory Compliance

UK ABHI says regulation should be seen as more than merely compiling a technical dossier and applying a CE mark

Executive Summary

The EU MDR represents the biggest collective change in many years for medtech companies in terms of how they prepare their approach to market. With time running short for companies’ preparations ahead of the regulation’s implementation date of 26 May next year, the UK ABHI’s final pre-MDR regulatory conference in late October will be both a checklist for companies en route to compliance and a debate about the wider role of risk in regulatory compliance.

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