New EU regulations: IVDR and 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 IVDR has an impact on all in-vitro-diagnostic medical devices, including blood glucose meters and test strips. The MDR covers all medical devices, including insulin pumps with related consumables, lancing devices, and diabetes management apps. 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 these products to be used in the EU.
At Roche Diabetes Care, we understand that the new regulations aim to increase patient safety by improving the quality and safety of medical devices and harmonising the legislation within the European Union. We are committed to managing the important transition over the coming years, to meet both regulatory requirements and our customers' needs by ensuring availability of our products to healthcare professionals and people with diabetes. We are committed to recertify all products as soon as reasonably possible and within the deadlines set by the regulatory authorities. All necessary processes and steps are in place to meet the changes within the designated timeframe.
Roche Diabetes Care has assessed the impact of the new regulations on its products and has allocated skilled personnel and the appropriate resources to address the regulation changes. A project team within Roche Diabetes Care has been working on implementing the new regulations since 2018 involving all affected areas of the organisation.
In 2020, Roche Diabetes Care successfully certified all of its Class I medical devices to be compliant with the MDR. The Notified Body of TÜV Süd Product Service GmbH certifies that the mySugr app with the modules mySugr Logbook (Class IIa) and mySugr Bolus Calculator (Class IIb) comply with the new Medical Device Regulation (MDR). Roche Diabetes Care is therefore confident that necessary processes and steps are in place to ensure continued market access for our product portfolio.
ISO 9001:2015 Certification
ISO 9001 is the internationally recognised standard for Quality Management Systems (QMS).
Roche Diabetes Care is ISO 9001:2015 certified, and we strive to consistently provide products and services that are of high quality, meeting statutory and regulatory requirements. We regularly perform internal audits to ensure our QMS is working efficiently, and identify where improvements to our processes can be made. This ensures we can serve our customers to the highest standard, enhancing customer satisfaction.