By Sean Fenske, Editor-in-Chief
 
Companies were beginning to get nervous in terms of keeping their products on the market in the EU. With the impending deadline for transition of MDD to MDR for legacy products already in hospitals and doctor’s offices, there would have been a significant shortage of medical devices available, potentially impacting quality of care. As a result, the EU Parliament voted to extend the deadline.
 
To find out the details of the new deadlines for transition and its impact on testing for medical device manufacturers, Jordan Elder, director of regulatory affairs at Regulatory Compliance Associates Inc., and Thor Rollins B.S. RM(NRCM), VP, global market segment leader—Medical Device at Nelson Labs LLC, took time to address a number of questions around this important issue. They provided a comprehensive overview of what considerations medtech firms should keep in mind when looking at the new deadlines and their products they’d like to keep on the EU market.
 
Sean Fenske: The EU MDR went into effect in May 2021 so can you please explain what was postponed with regard to the latest action involving the MDR?
 
Thor Rollins: One of the latest actions involving the EU MDR that was postponed was the application of the Unique Device Identification (UDI) system for certain low-risk medical devices. The EU has delayed the UDI system’s full implementation for low-risk devices until 2027. Also due to the limited capacity of Notified Bodies, the general need for registration was also pushed back.
 
Jordan Elder: To expand on that second portion, this update does not change any of the current safety and performance requirements under the MDR, nor does it change any of the newly introduced regulations. This extension only amends the transitional provisions to give more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation. This extended transition period applies only to “legacy devices” or those covered by a certificate or declaration of conformity issued under the MDD before May 26, 2021.
 
For medical devices covered by a certificate or a declaration of conformity issued before May 26, 2021, the transition period to the new rules is extended from May 26, 2024 to December 31, 2027 for higher risk devices (Class IIb and Class III), December 31, 2028 for medium and lower risk devices (Class I and Class IIa), and May 26, 2026 for Class III implantable custom-made devices.
 
However, the extension of validity for these devices only applies if one of the following conditions is met:
 

1. The manufacturer has signed a contract with a Notified Body for the conformity assessment of the device in question at the moment of expiry.
2. A national competent authority has granted a derogation in accordance with Article 59 of the MDR.
3. A national competent authority has required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR.

 
The “sell-off” date—the end date after which devices that have already been placed on the market and remain available for purchase—has been withdrawn. Under the original requirements, any previously approved devices that had yet to be recertified but were still available for purchase would have been required to be completely removed from the market by May 26, 2025.
 
Fenske: What’s the situation in the EU that brought about the reason for this delay?
 
Rollins: There were many factors that went into the reason for the delay, two of the biggest reasons was the COVID-19 pandemic, which has put significant strain on medical device manufacturers, notified bodies, and regulatory authorities, and also the number of notified bodies and their resources. These two factors made it evident that keeping the original date would risk having approved medical devices for the market.
 
Elder: Regarding the number of notified bodies, currently, 36 have been designated under Regulation (EU) 2017/745. As of October 2022, an additional 26 notified body applications were being processed, with three of them at an advanced stage in the application process. At the time, notified bodies reported they had received a total of 8,120 applications from manufacturers for MDR certification. It was also reported only 1,990 MDR certificates had been issued to manufacturers. According to an estimation presented by the notified bodies, the number of MDR certificates issued to manufacturers by the original deadline (May 2024) would likely only reach around 7,000 with the current issuance rate.
 
In 2022, due to the reduced number of notified bodies and a significantly slower rate of MDR certificate issuance than initially expected, many regulators and government officials began to voice concerns that the current compliance deadline would create a shortage of legally marketed medical devices, putting patient safety at risk.
 
The MDR certificate bottleneck was further exacerbated by COVID-19, as Thor mentioned, and its impact on the global supply chain and clinical investigations. In order to prevent a medical device shortage and reduce the strain on the notified bodies and manufacturers, the European Parliament agreed to adopt the transition delay.
 
Fenske: What changes come with the MDR with regard to testing?
 
Rollins: The MDR introduces new requirements for testing medical devices, including new rules on clinical data requirements, post-market surveillance, and clinical investigations. The MDR also requires testing to the most current ISO standard; this includes tests like extractable and leachable testing and toxicological risk assessments. These tests were not required when most of these devices were originally approved and, therefore, have gaps when looking to renew their approval under MDR.
 
Elder: Exactly. The MDR requires manufacturers to submit significantly more documentation covering the total product lifecycle than previously under the MDD. A critical change with MDR is the clinical evidence necessary to demonstrate the safety and efficacy of the device. The rules on equivalence have been revised, making it more difficult for manufacturers to use this route in their clinical evaluation. Under the new regulation, device product classification is expanded with new and revised terms and classification rules. Manufacturers must be aware of how their product is now regulated to fully understand the level of clinical information required for their device and whether clinical testing is required.
 
In addition to the updated clinical requirements, biological evaluations are under more scrutiny by the notified bodies under the MDR. Manufacturers should be careful to ensure all stages of preclinical safety testing, including chemical characterization and evaluation, biocompatibility, and a toxicological risk evaluation, have been completed, as Thor mentioned.
 
In order to facilitate some of the new testing requirements, the MDR officially recognizes harmonized standards as a method for manufacturers to demonstrate conformity to the General Safety and Performance Requirements (GSPR). Demonstrating compliance with applicable harmonized standards allows manufacturers and notified bodies to streamline the conformity assessment process.
 
Fenske: Might this delay cause some companies to reassess their regulatory strategy in either keeping a medical device on the EU market or getting a new device to replace it certified?
 
Rollins: Yes, it certainly could. Ultimately, the delay provides more time for companies to prepare for compliance, but it also means they may have to continue selling their devices under the older Medical Device Directive (MDD) until the new regulations are fully implemented.
 
Elder: In addition, companies that have struggled to make the transition might want to reassess their strategy if they had considered discontinuing their MDR certification due to the rapidly approaching deadline. However, since the expectation is companies have already demonstrated their intent with their notified body to transition to MDR, most companies would not need to reassess their regulatory strategy beyond accounting for updated timelines.
 
Fenske: Given the delay for the recertification of MDD devices under the MDR, what timeline should device manufacturers be working under to keep a product on the market?
 
Rollins: Device manufacturers should work under the timeline of the EU MDR’s transitional provisions, which was extended as Jordan explained earlier. High-risk devices are subject to the shorter transition period ending in 2027, while low- and medium-risk devices have until the end of 2028 to complete a conformity assessment.
 
Elder: The MDR delay and subsequent MDD certificate validity extension require that manufacturers have already taken steps with their notified body to transition to MDR. Although the delay provides manufacturers more time to transition to MDR, manufacturers transitioning from MDD to MDR should work with their notified body to ensure an appropriate submission/review timeline and a smooth transition.
 
Manufacturers should avoid delaying their MDR transition more than necessary to ensure the notified body has sufficient time to review and issue the MDR certificates. Currently, notified bodies are scheduling technical file reviews more than 24 months out. Under today’s notified body timelines and bandwidth, a company that chooses to delay its transition for 20 months would be pushing its MDR certificate issuance into 2027, assuming there are no major issues (technical file deficiencies) or unforeseen delays from the notified body.
 
Fenske: From the testing standpoint, what changes with the MDR are creating the greatest challenges and why? What should device makers be doing in preparation?
 
Elder: The greatest challenge manufacturers face from a testing standpoint is the increased clinical evidence data requirements. Manufacturers should review the updated classification rules to determine whether their product’s device classification has changed under the MDR. A clinical evaluation plan (CEP) must be established. Manufacturers should review the new requirements for claiming equivalence to understand if their device may continue to utilize this pathway as a part of the clinical evaluation (where applicable). Manufacturers must demonstrate their device is “state of the art” as part of their clinical testing/evidence. Manufacturers should be aware that the need to include post-market clinical follow-up (PMCF) data as a part of the technical documentation conformity assessment will depend on the device’s risk classification and available clinical data.
 
Rollins: In addition to the clinical data and evidence challenges, I’d also point to the new rules on post-market surveillance and vigilance, and the stricter requirements for clinical investigations. Device makers should prepare by conducting comprehensive risk assessments and by conducting more extensive clinical studies and collecting more data on their devices’ safety and performance.
 
Elder: One last item to remember is a periodic safety update report (PSUR) is required for Class IIa, IIb, and III devices.
 
Rollins: Keep in mind, the changes are putting more emphasis on the chemical characterization requirements for high-risk devices and, because the industry is limited in capacity of these tests, manufacturers should not wait to start evaluating the biocompatibility requirements under MDR.
 
Elder: Manufacturers should not assume their clinical evaluation under the MDD will provide sufficient clinical evidence under the MDR. Manufacturers should review their existing clinical data and conduct a gap assessment to determine whether the device “conforms with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio is based on clinical data providing sufficient clinical evidence,” as is stated in Article 61 of the MDR.
 
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?
 
Elder: Don’t delay your MDR transition due to the deadline extension. Notified bodies are already at capacity and are scheduling more than 24 months out for MDR Technical File reviews. Use this extra time to ensure your company can seamlessly transition from the MDD to MDR.
 
Rollins: Well said. Medical device manufacturers should prioritize compliance with the EU MDR and work closely with notified bodies and regulatory authorities to ensure their devices meet the new regulation requirements. They should also stay informed about any new developments or changes to the regulations and be prepared to adapt their strategies accordingly.
 
Click here to find out more about Nelson Labs >>>>>