By Sean Fenske, Editor-in-Chief
 
The EU has been providing information regarding its transition to a new regulatory system for some time. The region replaced its Medical Devices Directive (MDD) with the Medical Device Regulation (MDR). If that’s not enough, the EU also elected not to grandfather in any preexisting devices to the new standard, thereby requiring all legacy medical devices to be recertified to the new system.
 
To further complicate matters, COVID entered in the midst of the rollout and created chaos and the need for a delay of some deadlines. As such, the new regulatory system has many orthopedic device manufacturers confused with regard to what they need to do, when, and why. At the top of the list for many of these companies is determining what testing they need to do to become compliant to the new MDR.
 
Fortunately, there are companies ready and willing to help clear up the confusion. Elizabeth Sydnor, director of microbiology at Eurofins Medical Device Testing, addresses a number of questions regarding the MDR in the following Q&A. She speaks to the impact on legacy products, the common pain points being encountered, and what testing needs to take place.
 
Sean Fenske: Is the EU’s MDR relevant to all orthopedic device manufacturers?
 
Elizabeth Sydnor: The European Medical Device Regulation (EU MDR) is relevant to orthopedic device manufacturers (legal manufacturers) that intend to produce, market, or sell their medical device on the European market, which includes all EU Member states.
 
Fenske: With regard to existing products already being used under MDD in the EU, what’s the impact of MDR?
 
Sydnor: Device manufacturers that have legacy products that are compliant with the previous Medical Device Directive (MDD)/Active Implantable Medical Devices Directive (AIMDD) are allowed to continue operating in the EU. According to Annex 1, most legacy devices that obtained CE marking under MDD will need to be recertified. However, careful considerations must be given in order to be compliant with the new regulation within the timeframe allotted for the legacy devices transition.
 
Fenske: Can you please identify and explain where the pain points are with MDR for orthopedic device manufacturers?
 
Sydnor: The new regulation is significantly longer with more annexes than MDD. The new regulation is not inherently different than MDD; however, being compliant will be no easy feat for an organization. MDR takes a more holistic approach when it comes to the medical device lifecycle in the market—development, testing, manufacturing, safety, etc. At the time of its release in 2021, an average of less than 20% of manufacturers were compliant to these new requirements.
 
One of the pain points is the need for increased traceability, requiring each medical device to have a unique device identification (UDI). The UDI is intended to provide a heightened level of traceability for all devices throughout the supply chain process.
 
Another challenge is that the scope of medical devices has expanded to include some non-medical devices, and these devices are intended to be used in a similar manner.
 
The final issue is the need for a clinical evaluation report (CER). This report is intended to show compliance to Annex 1 and provide objective evidence of such compliance.
 
Fenske: What is a clinical evaluation report and why is it important with MDR?
 
Sydnor: In Article 61, a clinical evaluation is explained as a process in which medical device manufacturers will plan, conduct, and document in a report the conformity of the product to the requirements provided in Annex 1.
 
Some of the requirements listed that should be considered are the process in which the evaluation is performed, a thorough review of existing scientific literature, a critical evaluation of the results of all clinical investigations, and the consideration of available alternative treatment options.
 
The good news for manufacturers is that a previously completed clinical evaluation process—in accordance with MEDDEV 2.7/1 rev 4—is essentially in compliance with the new requirements. However, this should be closely assessed.
 
Fenske: With regard to essential laboratory testing, what’s the impact as a result of MDR?
 
Sydnor: Testing laboratories have seen an increase in global medical device manufacturers needing supplemental testing to adhere to the new requirements of MDR. From a testing perspective, there are no major changes to the actual tests being performed from a chemical or microbial perspective. However, MDR (as with other regulations) continues to require manufacturers to provide evidence of execution of applicable testing along with evidence of material degradation and maximum number of uses.
 
Fenske: Can you speak to and explain the differences of MDR on single-use orthopedic devices compared to those that are reprocessable?
 
Sydnor: According to the regulation, only single-use devices that have been placed on the market prior to May 26, 2021, may be reprocessed. It also states any person that reprocesses a single-use device to make it suitable for further use will be considered the manufacturer of the reprocessed device. They will be required to adhere to the obligations relating to traceability as stated before for all other medical devices.
 
Fenske: What is the timetable for orthopedic device manufacturers to transition to MDR?
 
Sydnor: There are several transitional provisions in place. Devices that have obtained a certificate from a notified body between May 25, 2017 and May 26, 2021 will be allowed to continue operations in the EU market until December 31, 2027.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
 
Sydnor: It’s important to understand how this regulation will impact your organization’s daily operations. Some other items to consider are the impacts to the organization’s quality management system, the maintenance of open communication with notified bodies as changes are being made in order to avoid a bottleneck, and the knowledge of when your specific device will need to be complaint to continue operations in the European market.
 
Click here to find out more about Eurofins Medical Device Testing >>>>>