Proposed delay to medical device reforms in light of the Coronavirus pandemicPrint publication
The European Commission is currently working on a proposal to postpone ‘the entry into force of the new medical device regulations (MDRs) for one year’ Stefan De Keersmaecker, a spokesperson for the European Commission has confirmed.
The MDRs are set to introduce new and extended obligations on manufacturers and others in the supply chain of medical devices. Changes include new risk classification criteria, increased requirements for clinical evidence, new vigilance reporting timescales and obligations on economic operators in the supply chain who must themselves demonstrate compliance.
The EU Regulation on Medical Devices 2017/745 entered into force on 25 May 2017, whereby three and five year transition periods began for the MDRs and In vitro diagnostic Medical Devices Regulations (IVDRs) respectively. It was originally envisaged that these regulations would be directly applicable in EU Member States from 26 May 2020 and 2022 respectively.
Given that the 26 May 2020 date is fast approaching, it is expected that the proposal to postpone the coming into force of the MDRs will be submitted to the European Commission in early April.
What does this mean for medical device manufacturers and economic operators?
It is thought that the delay will relieve pressure ‘from national authorities and industry and allow them to focus on urgent priorities related to the coronavirus crisis’, De Keersmaecker explained. This move will be welcomed by medical device manufacturers and economic operators, who will be able to put aside preparatory efforts to ensure compliance with the new MDRs and instead focus their resource on responding to the Coronavirus pandemic.
A delay of one year will mean that 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, particularly the requirements to obtain CE certificate validity from a notified body. Medical device manufacturers will be able to maintain operation under certificates obtained under the current medical device Directive, which will continue to be valid.
A delay of one year will of course mean that the MDRs are likely to come into effect after the Brexit transition period, meaning that not only will the IVDRs never be in force in the UK, the MDRs will also never be applicable in the UK either. The government will therefore have to address whether they wish to implement similar regulations in the UK following the end of the Brexit transition period.