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EU Medical Devices Regulations (MDR)
B. Braun Medical Inc. achieved (EU) 2017/745 certification in September 2022. This was through initiation of comprehensive measures and application of resources to ensure compliance with applicable new requirements of the regulation. Our certification includes Class I sterile and Class IIa products within our portfolio.
As provided under the most recent amendment to the regulation, (EU) 2023/607, we are working diligently with our Notified Body (TUV SUD) for extension of our EC Certificates under the allowable four-year time frame for submission and approval of our remaining CE marked product portfolio.
We assure you that we evaluate all measures for the implementation of EU MDR with a sense of responsibility and the greatest possible care. With our extensive portfolio and know-how, we will continue to support our customers and contribute to process improvement and workflow optimization. We supplement this approach with individual system solutions to optimize the economic relationship between costs and revenues.
As the only family-owned company among the 20 largest manufacturers of medical devices worldwide and with 180 years of tradition, we think long-term and want to work together with our customers in a trusting relationship over many years. Partnership and fairness are vital for us.
After publication of the MDR on May 5, 2017, the regulation entered into effect on May 25, 2017 with a transition period through May 26, 2021 (after postponement of one year due to the COVID-19 pandemic). There was then an allowed grace period during which EC Certificates for MDD products could be extended until May 26, 2024. This grace period allowed for EC Certificates to remain valid (e.g. for risk Class II and III products), unless replacement MDR certificates are mandatory (e.g. for Class I products). Subsequently on March 15, 2023, an amendment was published, (EU) 2023/607, which provided conditions by which extension may be approved past the May 26, 2024 date.
The below timeline and link outline grace period and conditions:
https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf
Only devices covered by a Notified Body certificate or a manufacturer’s declaration of conformity issued before May 26, 2021 can potentially benefit from the extended transition period:
Conditions to be fulfilled to benefit from extended transition period: