Roche signs EU Declarations of Conformity for Class I devices
All Class I diabetes care medical devices made by Roche comply with Medical Device Regulation (MDR) after the company completed official documentation, it has been announced.
Roche has now signed the EU Declarations of Conformity which means insertion devices such as the Accu-Chek Link Assist and lancing devices like the Accu-Chek FastClix AST, fully comply with the MDR requirements.
The Conformity mark is an important step in Roche’s strategy towards MDR certification of its entire diabetes care portfolio.
In a press release, the company said it is “on the right track” in achieving a smooth transition for all Class IIa, IIb, and III medical devices in its diabetes care portfolio, such as its insulin pumps, sterile consumables and lancets.
Due to the COVID-19 pandemic, the European Commission had 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.
Greg Smith, Global Head of Global Quality and Regulatory Affairs at Roche Diabetes Care, said: “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.
“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.”