The European Union In-Vitro Diagnostic medical devices Regulation (IVDR) fully applies as of May 26, 2022.
Making sure patients and healthcare professionals can access safe, high quality and effective diagnostic solutions has always been our number one priority at Roche. This is why, since 2017, teams from across Roche have worked tirelessly to ensure we can continue to provide essential diagnostic solutions for patients and customers that meet the new European Union (EU) quality and safety standards.
5 years in the making
In 2022, Roche is on its way to full IVDR compliance having taken all the necessary steps to successfully meet IVDR. Our journey started in 2017 with six quality management systems (QMS) and over 2,500 material numbers to transition to the new regulation. After years of demanding groundwork, the first important milestones were reached in 2020, with the designation of our two notified bodies and the first QMS audits passed. As we closed 2021, Roche successfully passed its six QMS audits and received its six IVDR QMS certificates.
At the date of application for IVDR on May 26th, 2022, the vast majority of Roche’s IVD portfolio was recertified, thanks to over 1,000 employees involved in the transition worldwide, and tens of millions in Swiss Francs invested in our programme over five years.
With IVDR now in full force, Roche will focus on re-certifying all outstanding products (dependent on the availability of external infrastructure), having full oversight on third party readiness, and ensuring post market surveillance.
Adjustments to the IVDR’s transitional provisions
On 15 December 2021, the European Parliament voted in favour of adopting in full the IVDR amendment proposed by the European Commission regarding the adjustment of transitional provisions to allow a progressive rollout of the regulation. The amendment was endorsed by the Council on 20 December 2021 and then published in the EU Official Journal (OJ) on 7 January 2022.
To ensure patients can continue to benefit from future innovation in diagnostics, it’s essential that the supporting regulatory infrastructure is in place to do so. Roche shares the goal of regulators and authorities to successfully transition to the IVDR, and to safeguard timely supply of compliant, vital products to healthcare systems and patients.