The COVID-19 pandemic is having a significant impact on the medical device industry, including preparations for the upcoming implementation of the Medical Devices Regulation.
On April 17, 2020, the European Parliament voted in favor of the Commission’s proposal to postpone the effective date of the Medical Device Regulation (MDR) by one year to May 26, 2021. Although the legislative process is not yet complete, this vote makes the postponement highly likely. The changes will take effect upon publication in the Official Journal.
A delay to prevent shortages
The postponement helps prevent regulatory-related shortages of already-approved medical devices and allows for exceptions (derogations) to the normal conformity assessment procedures for specific devices throughout the EU, in order to ensure the rapid availability of devices needed to address the COVID-19 crisis.
It also aims to give national authorities, notified bodies, manufacturers, and others time to prioritize the fight against the coronavirus pandemic. However, the postponement does not alter the fact that notified bodies make independent decisions regarding when to accept applications for recertification under the directives.
Requirements for Swiss Manufacturers
Medical devices may be placed on the market within the EU single market under the current European and national regulatory framework until May 26, 2021. Even if the effective date is postponed, manufacturers must continue their efforts to address existing gaps in the MDR.
The one-year transition period, once finally adopted, means that the current Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) would continue to apply until May 26, 2021. Swiss manufacturers will not be required to meet the requirements of third countries before May 26, 2021, as the current Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) falls within the regulatory framework of the directives. There is no guarantee that the MRA will be updated in time, as the crucial referendum scheduled for May 17 was canceled due to the COVID-19 pandemic. The Swiss government will likely not set a new date until the end of May.