New Achievements in MDR Compliance: A Comprehensive Update with the Launch of the eIFU (electronic Instructions For Use portal)
Since obtaining our initial MDR certificate
in 2021, we have been actively striving to align
our comprehensive product range with the new
Medical Device Regulation (MDR). Our recent
introduction of an electronic Instructions for Use
(eIFU) portal marks another achievement in our
dedication to quality, patient safety, and techno-
logical advancement, offering digital product
documentation to healthcare providers globally.
Quality Management and First Product Certificates
In 2021, our quality management system was certified according to MDR by our Hamburg-based Notified Body (Medcert/DNV). At the same time, we received our first MDR product certificate for screw-in acetabular cups, marking the beginning of an intensive recertification process for thousands of individual implants and instruments.
Expansion of MDR-Certified Portfolio
To date, we have received a total of 21 Class III product certificates under MDR. These certifications cover a wide range of systems, including the Modular Trauma Heads, the BiMobile Dual Mobility System, the MobileLink Acetabular Cup System, the CFP Hip Stem, and the Endo-Model Knee System (EVO, OptiStems). Our recent Class III approvals culminated in the LINK Embrace Shoulder System, which was also the first product certified by our second Notified Body, ItalCert in Italy. One additional Class III system – MP Monoblock Hip Stem – are still in the certification process and is expected to be approved soon.
Class IIb Systems and Comprehensive Portfolio Transition
In addition to our Class III devices, we have six Class IIb product systems. Four of these have already received MDR certification, while two are still under evaluation. In addition to the implants themselves, all associated instruments have been transitioned to MDR compliance, totaling approximately 10,000 products – approximately 5,500 implants and 4,500 instruments.
As part of this recertification effort, we also decided to discontinue more than ten complete systems or individual product lines because the resources required to update and maintain them under MDR were not commensurate with clinical demand or expected benefit.
Revising Technical Documentation and Transitioning to eIFU
One of the most important undertakings in meeting the MDR requirements was a comprehensive overhaul of our technical documentation. As part of this process, we moved from printed instructions for use to a modern, paperless eIFU system. All newly certified products now carry the eIFU symbol on their packaging, directing users to our dedicated LINK eIFU portal: https://eifu.link-ortho.com.
This portal centralizes all product information, allows quick searches by part number, and provides PDFs for instant download. By eliminating paper inserts, we reduce our environmental footprint, streamline production, and ensure that clinicians always have access to the most up-to-date product information.
Continued Commitment to Quality and Innovation
Our achievements to date demonstrate an unwavering commitment to patient safety, regulatory compliance, and continuous improvement. Achieving multiple Class III product certificates under the MDR reflects the robustness of our quality management system and our willingness to meet the highest international standards. As we move forward with final Class III approvals, our expanding MDR-compliant product portfolio and newly launched eIFU portal together underscore our commitment to excellence in orthopedic care.
