It was announced this week that the European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.
The new regulation was due to come into force on 26th May this year but in light of the pandemic, and calls from trade bodies, the Commission has confirmed it is working on a proposal to postpone the application date.
The Commission said: “With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May, its deadline for entry into force. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the Coronavirus crisis.”
Trade association MedTech Europe, who called for the postponement of its implementation earlier this week, welcomed the Commission’s action, but said that a similar solution is needed for In Vitro Diagnostic Regulation (IVDR) – which is due to come into force on 26 May 2022.
A statement from MedTech Europe read: “We welcome the announced intention of the European Commission to propose the postponement of the date of application for the Medical Devices Regulation by 12 months, and we also welcome the support that the European Parliament has expressed for this.
“Once adopted, this measure would enable healthcare stakeholders to maintain focus on fighting the COVID-19 pandemic while keeping healthcare systems running. Rest assured that our industry is putting all its efforts to deliver needed medical technologies to patients and healthcare professionals during these difficult weeks.
“For the In Vitro Diagnostic Regulation, we remain convinced that a similar solution is needed. Although this Regulation has a longer implementation time, diagnostic manufacturers and authorities alike must prepare for major changes and requirements to adapt to the new regulatory framework. Right now, their capacity is focused on the critical task of keeping diagnostic tests available, despite the challenges the pandemic is creating for their production and distribution. By providing the same solution for the in vitro diagnostics and medical devices sectors, the EU would be doing, even more, to keep health systems up running effectively in times of the COVID-19 pandemic.”