The European Commission is working on a proposal to delay the implementation of the Medical Devices Regulation EU 2017/745 (MDR/the Regulation) by one year, which is due to become effective on 26 May 2020. The proposal is expected to be submitted early April. The Commission spokesman Stefan de Keersmaecker emphasised that it is of vital importance that the European Parliament and the Council of Ministers adopt the proposal quickly, as the deadline for the Regulation to enter into force is approaching.
Why does the deadline constitute a problem for healthcare stakeholders?
The new regulation introduces a longer timeline for placing medical devices on the European market. Moreover, all medical devices are required to be re-assessed to ensure that they comply with the requirements. This entails increased responsibility for all actors in the medical device supply chain.
The COVID-19 outbreak, currently being the top challenge for the healthcare sector globally, has significant impacts on the preparations for compliance with these new requirements. On the other hand, the MDR Regulation becoming effective at the end of May 2020 might have serious consequences on manufacturer capacity to produce necessary medical equipment such as breathing masks and protective clothing.
The need for a deferral
Currently, the main focus of the healthcare providers is overcoming the COVID-19 outbreak. The pandemic and its consequences have disrupted preparations to become compliant with the Regulation, as all resources have been directed to manage the coronavirus crisis.
For these reasons, representative bodies in the med-tech industry have been demanding the deferral of the implementation of the Regulation. MedTech Europe, BVMed (the German Medical Technology Organisation), and the Association of British HealthTech Industries (ABHI) have asked for a delay, among others.
Delaying entry into force will help healthcare providers prioritise the actual needs regarding the pandemic, while ensuring that manufacturers will still be able to provide healthcare systems with the necessary medical devices and technologies. Hence, the deferral will alleviate pressure on healthcare stakeholders as they will be able to prioritise the most urgent needs sourced by the current crisis.
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