MDR Transition for B. Braun
B. Braun Medical Inc. has initiated comprehensive measures and provided resources to ensure the implementation of the EU MDR. The implementation of EU MDR with the applicable new clinical requirements, additional documentation, and reporting obligations involves considerable work and a coordinated effort as well as increased cost for us as a manufacturer.
During this ongoing process we have extended our EC Certifications under the allowable four year time frame for compliance to EU MDR for our CE marked products until May 2024. Although we have extended our EC Certifications, we are pursuing the scheduling of our EU MDR site audits with our Notified Body and are working diligently to transition our Quality Management System and CE marked products to the new requirements.
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 decisive for us.
Areas of Focus for New EU MDR
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 evey 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.
MDR Implementation Timeline
After publication of the MDR on May 5, 2017, the regulation entered into effect force on May 25, 2017 with a transition period until May 26, 2021 (after postponement by one year due to the COVID-19 pandemic). During the MDD grace period which extends until May 26, 2024, MDD certificates will still remain valid (e.g. for risk class II and III products) unless replacement by MDR certificates is mandatory (e.g. for class I products). After May 26, 2025 products covered by MDD certificates cannot be placed on the market any longer.
Registration of medical devices in EUDAMED, as well as reporting of UDI data, will be required starting in May 2022, as the EUDAMED launch date was postponed from the original May 2020 date.
Helpful MDR Information Links
- Current version of EU MDR: https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=uriserv:OJ.L_.2017.117.01.0001.01.DEU&toc=OJ:L:2017:117:FULL
- Regulation on the postponed MDR implementation due to COVID-19 pandemic: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:130:TOC
- European Commission Medical Device Coordination Group (MDCG) Documents: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
- Notified Body Operations Group (NBOG) Documents: https://www.nbog.eu/nbog-documents/
- Manufacturer’s of Medical Devices Factsheet: https://ec.europa.eu/docsroom/documents/31201
- Step by Step Implementation Model for MDR: https://ec.europa.eu/docsroom/documents/30905
- List of Requirements for Manufacturers of Medical Devices: https://ec.europa.eu/docsroom/documents/30961
B. Braun OEM & Material Information Contact
OEM EU MDR Customer Letter
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