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EU Medical Devices Regulations (MDR)

(EU) MDR Transition and Compliance for B. Braun 

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.

Areas of Focus for New EU MDR

eu-medical-devices-regulation

Essential scopes include:

  • Within the rules of classification there have been several changes. In addition to the implementation of the new Class Ir (reusable surgical-invasive instruments), the requirements for implantable products have increased significantly. Moreover, numerous product categories were matched to a new risk class, which can mean an upgrade for those products.
  • The MDR increases requirements for the clinical evidence of medical devices. In the future, all medical devices need to be provided with a clinical evaluation regardless of their risk class.
  • The newly implemented “Scrutiny“ procedure constitutes an increased surveillance before market entrance for new, implantable products of the risk Class III, as well as drug-eluting products of Class IIb. Several requirements have to be accomplished to assess medical devices. There is also an obligation to conduct unannounced audits of manufacturers.
  • A “Registration Master File” will exist for every medical device, within which technical documentation of the product will be provided by the manufacturer. The MDR raises the requirements concerning the technical documentation by the manufacturers and makes the documentation more extensive and complex. 

New (EU) MDR Timeline

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:

  • May 26, 2021: All devices, except those covered by the extended transition period, must comply with the MDR (e.g., Class I, new devices with a significant change)
  • May 26, 2021: End of transition period for legacy devices that do not meet the conditions for application for the new transition periods
  • May 26, 2021: End of derogation for Class III custom-made implantable devices
  • Dec. 31, 2027: End of transition period for Class III and Class IIb implantable devices
  • Dec. 31, 2028: End of transition period for other Class IIb, IIa, Class I sterile/measuring devices, devices requiring notified body involvement
     

Conditions to be fulfilled to benefit from extended transition period:

  • May 26, 2024: Deadline to lodge an application for MDR conformity assessment and have an MDR QMS in place
  • Sept. 26, 2024: Deadline to sign a written agreement with a Notified Body and transfer appropriate surveillance to a MDR Notification Body (where applicable)
  • Devices continue to comply with previously applicable EU legislation (MDD/AIMDD)
  • No significant changes in design or intended purpose
  • Devices do not present an unacceptable risk to health or safety

 

Helpful MDR Information Links

B. Braun OEM and Material Information Contact

Email: info-usa@bbraunoem.com

Phone: 1-800-359-2439