The new European Union Medical Device Regulation ("EU MDR"), published in May 2017, represents the largest regulatory overhaul in the medical device industry in decades. The new regulation brings about substantial changes for both medical device companies and Notified Bodies, in an effort to enhance transparency and patient safety. The mandatory deadline for compliance is May 2020, and while that may seem far away, there is an enormous amount of work to be done. Paul Brooks, Executive Director at the Regulatory Affairs Professionals Society ("RAPS"), noted in an article titled 6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation, "For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key...Just fully understanding the MDR, conducting the gap assessments and analyses needed to identify where more work is required and plotting a course to compliance is quite time-consuming itself."
Achieving compliance with the EU MDR is an exhaustive, time-consuming undertaking, requiring a detailed and documented implementation plan, cross-functional input and coordination, full executive management buy-in, formal governance and oversight, and proactive involvement of both internal and external resources. All of this needs to be done the right way, and that takes time. Many companies have wisely not only begun their implementation work, but are well underway on their path to timely compliance. However, there are some that are choosing to push off their preparations, even planning to wait until 2019 to get started...these companies are playing with fire and, unfortunately, could find themselves in crisis mode come 2020.
With 123 Articles, followed by 17 Annexes, the EU MDR is quite dense and voluminous. It carries many substantial changes that need to be addressed, including enhancements in critical areas such as clinical documentation, post-market surveillance, vigilance and trend reporting, labelling, the EUDAMED database, classification, and more. Industry experts, including representatives from Notified Bodies, have been urging companies for months to commence and progress their implementation work as soon as possible. Here are just 5 of the warnings we've been hearing regarding the risks associated with delaying this critical work:
1) Notified Body Backlogs - Notified Bodies are required to obtain specific designation under the EU MDR before they can conduct the necessary audits. As a result of this designation requirement, as well as the additional workload and scrutiny that the new regulations bring, the number of Notified Bodies is shrinking; a trend that will likely continue. Therefore, demand for the services of Notified Bodies is expected to far exceed the available supply. The Notified Bodies themselves have been alerting the industry that there will likely be significant backlogs in scheduling audits, and manufacturers should plan their timelines accordingly. RAPS reiterated this concern on their website as follows: "There is also a very real concern about the capacity of Notified Bodies to complete all the necessary conformity assessments required for compliance with the MDR. There is the potential for significant backlogs toward the end of the transition period which means waiting too long could be a particularly risky strategy." The last thing you want is to find yourself in the helpless position of waiting months and months to get on the audit calendar of your Notified Body while the deadline draws closer. The solution...start now to stay ahead of the game.
2) Limited Resources - In order to satisfy the extensive requirements of the EU MDR, most companies are prudently utilizing a combination of internal staff and external consultants. Given that EU MDR is a new regulation and organizations are going through the implementation for the first time, the population of qualified subject matter experts is tight to begin with. With each passing day, this pool of experts will continue to dwindle as more and more of these talented consultants get scooped up by companies moving quickly to progress their implementation efforts. Those organizations that get started early will have their choice of the best and brightest consultants in the industry, while the companies that delay will have a much less impressive talent pool to select from. Moreover, as the available supply of qualified experts diminishes, the costs for such labor will undoubtedly increase since only very limited resources, if any, will remain to satisfy the ongoing demand.
3) More Time-Consuming Audits - Those Notified Bodies that successfully obtain designation under the EU MDR are finding themselves under increased scrutiny and pressure. Consequently, there is a strong expectation that the audits, including unannounced inspections, will be even more detailed, more extensive, and more rigorous than what manufacturers have experienced in the past. The number of questions posed by the auditors and procedures performed will expand, and the number of audit issues, comments, and nonconformities will likely escalate driving the need for increased remediation efforts. What does all of this mean? Quite simply, audits will take much longer to complete, and companies will need to consider this extended timeline when planning their implementation work.
4) Uncertain Financial and Business Impacts - Achieving and maintaining compliance with EU MDR will certainly impact budgets. Exactly how much it will cost obviously will vary from company to company, with more insight coming only once companies complete their gap assessments, determine the specific action steps and resources needed, and commence compliance activities. Further, it is expected that EU MDR compliance will impact a multitude of crucial business decisions including ROI assessments, new development procedures, and product portfolio prioritization and "go/no-go" determinations. Acquisition and divestiture analyses may also be affected by these new requirements. These are highly important factors for any medical device company, and regardless of compliance deadlines, executive management will want, and expect, clarity on these uncertainties as soon as possible. Late in the game surprises with respect to cost and business impact will not be well-received...get started so you can get the answers early.
5) Severe Consequences of Non-Compliance - The EU MDR has become a central focus in our industry, rising to the very top of priority lists for quality and regulatory leaders. Missing the deadline is simply not an option, as the consequences of doing so can be disastrous. Losing CE mark certification, having to withdraw devices from the market, or delaying the introductions and launches of certain devices can be crippling for any company. Such outcomes would not only bring about incremental costs and financial distress, but would also potentially cause long-term damage to the business and reputation of many otherwise outstanding organizations.
One of the Notified Bodies, BSI, explains with regard to EU MDR, "Given the magnitude of the changes involved, it is prudent to start developing your implementation plans as soon as possible in order to have time to navigate the complexities and accommodate external factors outside your direct control." Remember, not only is this new for you, but it is new for Notified Bodies. As such, it is likely that there will be bumps in the road and unforeseen obstacles, and you would be wise to assume everything will take longer than initially expected as all parties navigate their new responsibilities for the first time. If you happen to be one of the lucky few that sail seamlessly through the entire implementation without any issues, then it will be time to celebrate... there is no penalty for getting it done early. You'll simply find yourself in the enviable position where you can sit back and relax while others are scrambling.