The new Medical Device Regulation (MDR) goes live
Starting from today, the new Medical Device Regulation (MDR) replaces the Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) in the European Union. With the full implementation of the MDR that governs the production and distribution of medical devices, compliance is mandatory for all companies that want to bring Conformité Européenne (CE) marked products to the market.
At Roche Diabetes Care, preparation was key to meet this important deadline so our vital products continue to be available to healthcare professionals and people with diabetes without interruption. Antje Nagler, MDR/IVDR Project Leader at Roche Diabetes Care, shares her experiences about the transition to the new regulation. Read about the milestones reached and those ahead, about complex challenges, and a good night's sleep.
Was the MDR deadline giving you and your colleagues sleepless nights?
Our MDR team did a great and incredible job so far - knowing that the transition to the new regulations is on top of daily business activities and other projects. This is one reason I still sleep well, even though the workload for the entire team is extremely high and nights are sometimes quite short. A big thank you to the team for their endless enthusiasm, motivation, and energy to make our MDR journey a success so far!
What difference will the new MDR make for people with diabetes?
The new MDR ensures higher patient safety and more transparency. For instance, it requires the publication of information on devices and on clinical and performance studies related to their conformity. The new European Database for Medical Devices and In-Vitro Diagnostic Medical Devices EUDAMED will play a central role in making data available and increasing both the quantity and quality of data – for the manufacturer and the customers which are on our end people living with diabetes and healthcare professionals.
Was Roche Diabetes Care able to certify all of its medical devices on time?
Yes! We accomplished all necessary certifications for the MDR date of application on 26 May 2021. Our strength at Roche Diabetes Care is that we can rely on a robust Quality Management System which has been established over many years. We at Roche Diebates Care and mySugr successfully passed the MDR audit for our Quality Management System in 2020. On the product side, all class I devices from Roche Diabetes Care are compliant with the MDR with the exemption of the software. Our notified body TÜV SÜD also certifies that the mySugr app with the modules mySugr Logbook, mySugr Bolus Calculator and the mySugr Pump Control comply with the new MDR from July 2020 on. Recently the entire Accu-Chek Solo micropump system passed three different TÜV SÜD tech file reviews and one clinical audit so the entire system is now MDR compliant.
These first certifications show that all our necessary processes and steps are in place to ensure a smooth transition for our portfolio. However, a lot of our medical devices with certificates issued under the previous directives may continue to be placed on the market until 26 May 2024. We are committed to managing timely certification for all of these products and meet both the regulatory requirements and our customers´ needs.
After the deadline is before the deadline: What's next on the agenda?
In addition to the MDR transition, Roche Diabetes Care must also be compliant with the In-Vitro-Diagnostics Regulation (IVDR) by 26 May 2022, as this regulation relates to our blood glucose monitoring product portfolio. We are confident that all our glucose meters will be IVDR-certified on time. As a first milestone, the IVDR audit for the Quality Management System was successfully passed in April 2021. In addition, we are working hard on the labelling changes, re-registration outside of the EU and global supply chain in order to safeguard the distribution of the CE marked devices worldwide. We are all aware that this is a tough timeline particularly for those devices which must be compliant by 26 May 2022, but as a team we will manage all the challenges within Roche Diabetes Care and together with our Roche Diagnostics colleagues. We look forward to successfully facilitating both transitions and helping people with diabetes to further experience true relief.
About the new Medical Device Regulation (MDR)
In 2017, the European Parliament and the European Council adopted two new laws, the Medical Device Regulation (MDR) and the In-Vitro-Diagnostics Regulation (IVDR). The MDR covers all medical devices, i.e. instruments and software, intended, interalia, to diagnose a disease or to support the treatment of a disease (e.g. insulin pumps with related consumables, lancing devices, diabetes management apps). The IVDR has an impact on all in-vitro-diagnostic medical devices, i.e. non-invasive tests that are performed on biological samples (e.g. blood glucose meters and test strips).
The aim of both regulations is to establish an effective, safe and harmonised regulatory system and to ensure better protection of public health in the field of in-vitro-diagnostic medical devices and medical devices. Compared to the current regulatory system, the new environment implements a lot of new and more stringent requirements (e.g. new classification system, vigilance, Notified Body involvement) that need to be followed as a pre-requisite for market access in the EU.
For more information contact: [email protected]