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Regulatory


IVDR: from directive to regulation


The EU medical device and in vitro diagnostics regulations improvement campaign has been a subject of discussion for many years, ever since the resulting legislation was published in the Offi cial Journal of the European Union (OJEU) on 5 May 2017, and subsequently ‘entered into force’ 20 days later on 26 May 2017. As the date of application for the new regulatory rules approaches, Gabriel Adusei, director of medtech consultancy Triune Technologies, explains how manufacturers can best prepare for the changes it will bring.


he European Commission advocates that the new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science and progress in law-making. The new regulations create a robust, transparent, and sustainable regulatory framework – recognised internationally – which improves clinical safety and creates fair market access for manufacturers and healthcare professionals. Unlike directives, regulations do not need to be transposed into national law. The MDR and the


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IVDR, therefore, limit discrepancies in interpretation across the EU market. Recent developments, such as the effect of the Covid-19 pandemic, led to the date of application for the MDR being postponed from the original date of 26 May 2020 to 26 May 2021. Despite the change, the provisions made under EU MDR Article 120.3 state that devices covered by valid AIMDD/MDD certificates may continue to be placed on the market or put into service until 26 May 2024, as long as they continue to meet the requirements of that legislation and there are no significant changes in their design or intended purpose.


Medical Device Developments / www.nsmedicaldevices.com


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