When COVID-19 caused the Commission to delay the MDR date of application by a year (May 2021), it was advised that the extra year be spent ensuring compliance with the new regulation. As the pandemic continues to pose an obstacle for the medical device industry, many device manufacturers are also citing the fact that they cannot complete conformity assessments under MDR since it typically requires an in-person visit from notified bodies.
The Commission’s Medical Device Coordination Group (MDCG) recognized the obstacle of in-person audits during the pandemic when it published guidance in April regarding remote assessments.1 The guidance, however, was framed for the soon-to-be-obsolete MDD and IVDD directives and offered very little guidance for MDR provisions. The guidance from the commission did not call out any flexibility as far as the MDR or IVDR, which could leave medical device firms in limbo.
If manufacturers cannot get audited under MDR and IVDR, it could cause bottlenecks as we get closer to the deadline. If firms have to wait until travel restrictions or social distancing measures are lifted before getting audited, that will cause a surge in demand that might potentially overwhelm the system. In light of this potential issue, the MDCG is asking the commission to allow notified bodies to perform virtual audits under MDR and IVDR. Additionally, they called out the concern that unless virtual audits are permitted, devices that are necessary for the pandemic would not be available on time under the new regulations.2
The MDCG references the belief that sufficient technology exists to effectively perform both initial audits under MDR and IVDR and surveillance audits. With teleconferencing technology, and even more innovative products like smart glasses or virtual reality, the group strongly asserts that virtual audits can be just as effective as in-person. If you need help navigating the EU requirements during the pandemic or need guidance on how to conform to MDR and IVDR requirements, EMMA International can help. Give us a call at 248-987-4497 or email firstname.lastname@example.org to get connected with our team of experts.
1European Commission (April 2020) Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions retrieved on 06/18/2020 from: https://ec.europa.eu/docsroom/documents/40705
2MDCG (June 2020) The need for virtual audits under the MDR and IVDR in the context of a pandemic retrieved on 06/18/2020 from: https://www.medtecheurope.org/wp-content/uploads/2020/06/MedTechEurope_PositionPaper_Virtual-MDR_IVDR-Audits_during_pandemic.pdf