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Roche completes certification of all Class I medical devices in its diabetes care portfolio under the new Medical Device Regulation

Roche announces that it has concluded the certification of all of its Class I medical devices in its diabetes care portfolio to the Medical Device Regulation (MDR). By officially signing the EU Declarations of Conformity, Roche commits itself that all of its Class I medical devices in its diabetes care portfolio, meaning devices with low-risk to patients like insertion devices (e.g. Accu-Chek Link Assist/ Accu-Chek Solo insertion device) and lancing devices (e.g. Accu-Chek FastClix AST), comply with the requirements of the MDR.

The EU Declarations of Conformity mark an important step in Roche ?s strategy towards MDR certification of its entire diabetes care portfolio. Realising that advanced preparation and early action is key to ensuring a smooth transition to the new requirements, Roche initiated the necessary steps early on. Roche has proven to be on the right track in achieving a smooth transition for all Class IIa, IIb, and III medical devices in its diabetes care portfolio with a higher risk to patients, such as insulin pumps, sterile consumables, and lancets. Due to the COVID-19 pandemic, the European Commission has postponed the date of application of the MDR by one year until 26 May 2021.

However, Roche was able to complete the important transition of Class I medical devices of its diabetes care portfolio to the new MDR ahead of schedule. “Ensuring compliance before the extended deadline strengthens our position as a leader and trusted partner in diabetes care for providing products of high quality and safety”, said Greg Smith, Global Head of Global Quality and Regulatory Affairs at Roche Diabetes Care.

“The official declaration resulted from a multi-disciplinary effort and marks a milestone in our commitment to ensure compliance with the new regulation. Now our sole focus shifts to working with our Notified Body to confirm compliance with our Class II and III medical devices.”


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