DECEMBER 202196. Changing rules on clinical data requirements for the various device classifications.7. Reinforced need for manufacturers to collect data about the real-life use of their devices after placing them on the market.Some specific properties of orthopedic devices will set an additional burden and are presented in the following.Specific questions of orthopedic devices under the scope of the MDRThe already existing up-classification of joint replacement devices for hip, knee and shoulder prostheses as Class III devices has been extended per Annex VIII 5.4. Rule 8 of the MDR to all total and partial joint replacement devices. Additionally, certain spinal disc replacement devices and implantable devices that come into contact with the spinal column will be up-classified to Class III with some exceptions. A position paper from Team NB and NB MED was presented to the EU Commission in early 2019 with the goal to enable a risk-based and pragmatic approach to classification of spinal devices according to the EU MDR. Due to short or long-time complications of orthopedic devices, revision procedures are common. For those revision cases, primary implants or specialized revision implants could be used. Since there are a lower number of revision cases compared to primary implantations, the collection of clinical data could be more cumbersome. This is also relevant for post-market data which needs to be presented in the PMCF-Report.Another aspect to consider is the huge number of legacy devices. They need to fully comply with the requirements of the MDR, as every first application under the EU MDR will be considered as an initial application. There will be no grandfathering for legacy devices. This could have an impact on the number of available orthopedic and spinal devices on the EU market. Manufacturers should have a plan in place by now addressing these aspects and enabling them to collect the relevant data before applying for the new legislation.This article only highlights some of the aspects relevant for orthopedic and spinal devices under the EU MDR. In the end, the main goal for all stakeholders should be to ensure that only medical devices which are safe, performing as intended and with a benefit-risk profile which is positive when compared to the current state of the art will have access to the EU market under the new framework. The main goal for all stakeholders should be to ensure that only safe medical devices, performing as intended with a positive benefit-risk profile will have access to the EU market under the new framework
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