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The implementation of the EU Medical Device Regulations is delayed by one year in light of the current Coronavirus pandemic

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09/04/2020

The European Commission have now considered and accepted their earlier proposal to postpone the entry into force of the EU Medical Device Regulations (MDRs) by one year, in light of the current Coronavirus pandemic.

The Commission have acknowledged that any delays to getting medical devices certified and on the market at this time must be avoided so fighting the global pandemic can be prioritised. This postponement will be welcomed by the health sector and economic operators alike who are now able to put aside preparatory efforts to ensure compliance with the new MDRs and focus their resource on meeting the ever increasing demand for medical devices across the EU.

Stella Kyriakides, Commissioner for Health and Food Safety stated in a Commission press release that ‘Our priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided. Today’s decision is a necessary measure in these very exceptional times.’

The Commission have set a new deadline of 26 May 2021 for the entry into force of the MDRs, by which stage medical device manufacturers and the wider supply chain must ensure they are compliant with the increasingly stringent regulatory requirements.  Of course, this date exceeds the deadline of the Brexit transition period, meaning the MDRs will never be applicable in the UK. It remains to be seen whether the government seek to implement similar regulations in the UK following the end of the Brexit transition period.

In the meantime, those in the medical device sector will continue to operate as they have done within the transition period, whereby devices can be placed on the market under the current EU Directives. To further support the continued supply of critical medical devices, regulatory flexibility has been provided at this unprecedented time, meaning non-CE marked medical devices can be supplied where there is a significant clinical need and no CE marked devices are available.

It is clear that the European Commission is taking pragmatic steps to support both manufacturers and end users across the EU by ensuring the availability of vitally important medical devices whist maintaining patient health and safety. Undoubtedly, these actions will be welcomed across the industry at these challenging times.

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