European Commission proposes delaying the May 2020 application of the EU Medical Devices Regulation 2017/745/EU
The European Commission has confirmed it is working on a proposal to delay for one year the date of application of the new EU Medical Devices Regulation 2017/745/EU (the “MDR”) in light of the Covid-19 global pandemic.
In a statement given by a spokesperson on 25 March 2020, the Commission confirmed that it intends to submit a proposal to the European Parliament and the Council in early April and called on those institutions to adopt it quickly given the approaching date of application of the MDR.
Absent such delay measures, the MDR will have mandatory application from 26 May 2020, introducing significant new and intensified requirements in terms of both pre-market assessment (subject to time-limited derogations for specified products) and post-market obligations on manufacturers and other economic operators in the supply chain.
The announcement will come as a welcome relief to medical devices manufacturers, especially those who were already facing challenges in obtaining requisite Notified Body certificates due to Notified Body capacity issues. The Covid-19 pandemic has only increased those challenges as Notified Bodies are not able to conduct on-site audits to issue certificates. It has also put significant strain on manufacturers who are facing increased demand for medical devices and personal protective equipment whilst experiencing disruption in their own supply chains.
The statement comes after MedTech Europe, the European industry association representing medical devices and in vitro diagnostic devices manufacturers, formally called for EU institutions to delay the implementation of the MDR and the In Vitro Devices Diagnostic Medical Devices Regulation 2017/746/EU (due to come into application 26 May 2022). MedTech Europe emphasised the need to ensure the main focus of manufacturers and other stakeholders (including national Competent Authorities) can be on helping healthcare systems cope with the pandemic in the coming months.
