IVDR certification of Swelab Alfa Plus and Medonic M32 hematology systems

In November 2022, Boule received IVDR certification for Medonic M32 and Swelab Alfa Plus hematology instruments. These Class B devices can thus be CE marked with our Notified Body BSI’s four-digit code 2797.

The in vitro diagnostic device regulation (IVDR) came into force 26 May 2017 with a five-year transition period. Due date for Class A devices was May 26, 2022. Accordingly, Boule’s Class A products such as the system reagents and cleaners all meet the IVDR requirements since earlier this year.

The transition period for Class B devices was prolonged to 26 May 2027. The IVDR certification of Medonic M32 and Swelab Alfa Plus instruments is therefore more than four years earlier than the regulations require for these Class B devices.

An in vitro diagnostic device directive (IVDD) has been in place in the European Union since 1998 (COUNCIL DIRECTIVE 98/79/EC). However, interpretation and application of the directive has been challenging, particularly as it only provided a low level of product review. IVDR allows for a more effective adoption of the IVD rules by clarifying the obligations for device manufacturers and other economic operators.

Compared with IVDD, IVDR increases emphasis on life-cycle management and demands more rigorous post-market surveillance work to ensure clinical safety. Traceability is enhanced by introduction of the unique device identifier (UDI), and transparency is increased by making performance studies public and accessible on the European Database for Medical Devices (EUDAMED). Through the designated notified bodies, control and monitoring by the national competent authorities and the Commission is improved.

With the IVDR certification of Medonic M32 and Swelab Alfa Plus instruments, Boule has taken its quality work one step further by adopting the more stringent IVDR requirements for these products. The clinical evidence for the devices is based on performance data and evaluations that demonstrate:
• Scientific validity
• Analytical performance
• Clinical performance

Post-market surveillance procedures, including post-market performance follow-up, are in place for continuous evaluation of the products throughout their life cycles.
The new regulation creates a robust, transparent, and sustainable regulatory framework that helps Boule ensure clinical safety of its products.



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