As one of the most impactful regulatory updates to the EU medical device market in recent years, the European Union’s Medical Device Regulation 2017/745 (MDR) has been a hot topic of conversation since it entered into force in May 2017.
Affecting some 500,000 medical devices, it was intended that MDR enforcement would begin in May 2020, after which any new device submissions for EU clearance would be required to comply. Devices that were already on the market would also need to be resubmitted under the new regulation once their clearance needed renewal — up to five years from the issue date or at the latest four years from the time of enforcement in May 2024.
However, with the COVID pandemic causing massive disruptions in global medicine, labor forces, and medical device supply chains, it became clear that the May 2020 deadline was unrealistic. To adjust, the enforcement date for new device submissions was initially pushed back one year to May 2021, while the May 2024 deadline for devices already on the market remained unchanged.
Now, the European Parliament has voted to delay the MDR transition further, with a staggered deadline extension schedule based on medical device risk.
The purpose of transitioning to the MDR
Moving from the previous Medical Device Directive (MDD) to the MDR carried one main objective: to offer a higher level of protection of health for patients and users. Under this umbrella, all medical devices, including new submissions and previously reviewed legacy devices currently on the EU market, would need to undergo a biological evaluation to make sure they are truly safe to be used on the patient. The MDR additionally expanded pre-market scrutiny for high-risk devices, enhanced the scope of regulated medical devices (some devices were “up classified”), strengthened post-market surveillance, and required more stringent clinical evidence and documentation.
While the goal of this transition – increased patient safety – is something we all strive for, the journey there has been an unexpectedly bumpy ride.
The transition means that all medical devices, old and new, must go through extra checks to make sure they are safe for use on patients. But, with so many devices needing review, both the companies making them and the EU notified bodies (NB) in charge of reviewing them are struggling to keep up. Despite encouraging progress being made, this has led to the point where NBs are facing the inevitability of not being able to review everything by the initial deadline of May 26, 2024, as set forth in Article 120(3) of MDR.
MDR extension proposal
In light of this, the European Commission (EC) proposed an official amendment to the MDR (and the IVDR) to help ease the pressure by extending the deadline set forth in the regulation. On Feb. 16, 2023, the European Parliament voted overwhelmingly to approve this amendment to the MDR to avoid the much-dreaded scenario of a shortage of life-saving products in the economic region. Due to risk to public health, the approval came without the standard 20-day waiting period.
The amendment takes into consideration the inherent risk a given medical device carries and recommends different deadlines for the required transition based on those risks. For example, devices that pose a higher risk will have a shorter extension (December 2027 deadline), while less risky devices will have a longer extension time window (December 2028 deadline). In addition, the amendment introduces a clear transition period (May 26, 2026) for class III custom-made implantable devices, which are currently not covered by Article 120(3) of MDR. For these special devices, an extension is given to obtain certification of their quality management system by a notified body.
This, however, does not mean we can lay back nor step back from this remediation pathway. This additional allocated time is granted to provide all sides with the most valuable resource we have to invest into the process and reach to the goal of implementing the MDR and ensure the devices out there are indeed safe to be used.
It is also important to note that the proposal strongly highlighted that the extensions are based on certain conditions; for example, only devices that are safe and for which the manufacturer has already taken steps to transition to the MDR will benefit from the additional time.
With this extension, the EC is trying to avoid a situation where currently marketed safe devices with expiring MDD certificates are pulled from the market simply due to non-conformity to the updated MDR (since they haven’t yet received their remediation certificate), leaving an unintentional gap and causing shortages of medical devices that could put patient safety at risk. In short, no one wants to create a scenario where a necessary medical device is not available for the patients who need it.
Much-needed collaboration on both sides
The Medical Device Coordination Group (MDCG), composed of representatives of all Member States and chaired by a representative of the EC, has addressed this issue in its position paper MDCG 2022-14, released in August 2022. The report proposes some possible solutions to increase NB capacity, including the introduction of hybrid audits and modification of the frequency of complete re-assessments by NBs, for instance.
The MDCG report also calls for the medical device manufacturers to ensure they take on this transition in a timely manner and avoid leaving it to the end of the transition period. The MDCG emphasizes the need for a structured dialogue between the NB and the manufacturers to increase efficacy and predictability of the review process. From my own experience, if this collaborative framework and dialogue can occur, the transition will be much smoother. Better understanding of the NB position, as well as their guidelines and best practices, will definitely add to this as well.
The MDCG also emphasizes the need to reduce the overall complexity of the conformity assessments for safe and effective legacy devices. For example, the appropriate use of clinical evidence for legacy devices is mentioned. The report also highlights that in cases where the device has a current CE mark under the MDD, the MDCG strongly encourages the NBs to leverage this evidence from the previous review cycle to avoid unnecessary duplication of work. Obviously, if evaluation standards have changed significantly since the MDD certification (e.g., more detailed toxicological evaluation for implantable devices per ISO 10993-18 and -17), additional information may be needed from the manufacturer to demonstrate continued safety for the device. However, if there are no substantial changes and there is no recognized risk from the device, then, based on available data and clinical use, there should be an avenue to streamline the transition.
The MDR aims to provide a higher level of protection for patients, but the transition has been anything but smooth. Manufacturers are struggling to keep up with the extra checks, and the EU notified bodies are overwhelmed. The MDCG also addressed the issue in its position paper, proposing solutions to increase NB capacity and encouraging manufacturers to engage in a two-way collaboration with the NBs to ease the transition process. The MDCG also highlights the need to reduce complexity and streamline assessments for legacy devices. The journey from MDD to MDR has been unexpectedly challenging for all. However, we can all agree that ensuring a fluid transition while maintaining patient safety is the ultimate goal.