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RAPS' Latest | 15 June 2017 | By Paul Brooks
When the EU’s new Medical Devices Regulation (MDR) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. 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. Following are six things you should be doing to get ready.
In order to figure out where you are going, you need to know where you stand. Manufacturers should initiate a plan to assess all of their current CE marked devices relative to the new MDR guidelines. For some products, this also means considering changes in classification, but for likely more than 90% of medical devices, their classifications will remain the same. That said, don’t assume just because a legacy device is not reclassified, that the steps to ensure it remains compliant will be quick or easy.
Understanding what has changed between the existing Medical Devices Directive (MDD) and the MDR is critical as it is highly probable for most legacy devices (CE marked under the MDD) that a review of Annex I, General Safety and Performance Requirements,will identify new conditions that will need to be addressed for every device. Clinical data, technical documentation and labeling will need to be updated. Also, it will be necessary to revisit processes including the quality assurance, risk management and postmarket expectations that will require careful review, planning and updating to re-implement in compliance with new requirements.
Your company is responsible for ensuring all its products will meet all the general safety and performance requirementsdescribed in Annex I, so it is important to identify potential deficiencies. Under the new EU regulatory approach, there will be no grandfathering of legacy or pre-MDR devices. This means that by the end of the transition process, every CE marked device must by fully compliant with the MDR. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that more than half a million different devices currently CE marked under the MDD must transition to fully comply with the MDR.
While many MDR requirements are similar to current state-of-the-art requirements under the MDD, the MDR is much more prescriptive and many devices will not have been fully evaluated against the newest requirements. Under the MDR, there is much greater emphasis on more thorough reviews by Notified Bodies to confirm manufacturers are fully compliant and devices are fully supported by adequate data and technical documentation. The MDR’s requirements for acceptable clinical evidence are more strict as well so it is very likely you will need new data and updated, robust clinical evaluations for most legacy devices. For some legacy products, you may determine the return on investment is not sufficient to justify the time and resources required to bring them into compliance. Conducting a thorough gap analysis will help you to evaluate how criteria changes will affect your products so you know where you will need to focus most of your time and efforts.
Time may be the most challenging aspect of the transition to the new requirements. Three years may seem like quite a long time, but as I alluded to earlier, there is much to do. 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.
For legacy, pre-MDR devices, the gap assessments should include elements that would normally be considered premarket, such as general safety and performance data, clinical evidence, risk assessments, technical documentation, planned postmarket clinical follow-up, UDI, labelling, entering data in the EU database when ready, etc. There are general ongoing requirements that need to be addressed, including quality management, risk management, general compliance, traceability, maintenance of technical documentation, consideration of new standards. You also will need to account for implementation of specific postmarket activities to meet the new, more prescriptive requirements. These include updated vigilance requirements, planed postmarket surveillance, periodic safety update reports and updating data in EU databases.
Once you have those the gap assessments completed, you will need to conduct the work to address the gaps you identified, supplementing the required data and documentation, and addressing the process and system changes. When you add up the hours of work involved, you may find you need to add more regulatory team members to handle it all. If so, factor in additional time and resources devoted to hiring new staff or identifying appropriate external partners. Budgets may have to be adjusted accordingly.
It is important to keep in mind that all stakeholders—device manufacturers as well as Notified Bodies and Competent Authorities—will be getting up to speed on the new requirements at the same time. There are likely to be practical challenges involved in compiling, reviewing and accepting data, and calibrating the level of data required among all stakeholders that may not be fully understood until the work is in progress, so give yourself some extra time to account for differences in expectations and unexpected interpretations.
Depending on the number of devices in your product portfolio, the amount of new compliance data and technical documentation you need could seem overwhelming. My suggestion is not undertake everything all at once. Rather, I suggest a pilot process, compiling data and documentation for one or two products as examples (for wide range of devices consider examples from different classification levels and different technologies) for Notified Bodies to evaluate to gain a consistent interpretation of what is considered acceptable under the new expectations. Almost all technical documentation will need some degree of updating, and all labeling also will need to be reviewed for MDR compliance. Once you analyze the requirements and develop a solid understanding of the Notified Bodies’ interpretations and have completed a calibration exercise, you will better positioned to assess the work required and you will be able roll out the update process more efficiently and confidently across the full portfolio of legacy, pre-MDR, products.
During the three-year transition period (May 2017–May 2020), for devices requiring certification, manufacturers can choose to comply with either the current MDD requirements or the new MDR. For those choosing the former, there will be up to four years’ additional transition time after the MDR date of full application in May 2020 when these legacy products may continue to be sold on the EU market. However, since all products eventually must comply with the MDR, and any changes to pre-MDR products after full application of the MDR negate MDD compliance, being prepared for full MDR compliance during the transition period may be highly advisable. Failure to do so may introduce additional challenges.
Managing product portfolios and systems under two differing sets of regulatory requirements could be tricky to balance. Companies with devices that comply with the MDR earlier may claim a competitive advantage in the market, and some procurement agencies and regulators that recognize CE marking outside of Europe maybe become conditioned to expect CE certificates to meet the latest requirements. 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 means waiting too long could be a particularly risky strategy.
As of today, we know that Notified Bodies will not be allowed to apply for designation under the MDR before November 2017, and the designation process could take 12–18 months or more to complete, meaning that the effective transition window will be significantly reduced. Many Notified Bodies currently designated under the MDD may not achieve designation under the MDR, or may decide not to apply for the designation. It is possible that some Notified Bodies may feel confident to begin conducting some conformity assessment work with manufacturers before designation, which may provide some valuable lead time to get ahead of late transition bottlenecks. In any case, it is strongly recommended that you start early and work with committed long-term Notified Bodies to confirm common expectations, and submission and assessment timetables.
While perhaps less than 10% of medical devices will be affected by reclassification, all manufacturers should become thoroughly familiar with the classification changes and determine whether they will have any impact on their devices. For those that are reclassified, there will be an additional learning curve and additional gaps to address. Up-classified products will need more significant Notified Body review, which will demand additional resources to prepare and take time to complete the necessary additional conformity assessment procedures with perhaps several rounds of questions. Some products in the orthopedic space, devices to administer medication via inhalation and active therapeutic devices, including closed-loop systems and automated external defibrillators are among those affected by reclassification. In addition, the MDR introduces new classification rules to determine the correct class of software and devices incorporating nanotechnology. If you are involved with any of these device types, be sure you know exactly how the revised classification rules affect your products.
One final important factor to consider is that although the MDR is published, a lot of guidance is still needed. Some details will be filled in later by the European Commission under implementing and delegated acts. Changes are inevitable, but if you are well prepared ahead of time, you will be better positioned to implement the necessary adjustments.
There will be a pre-conference workshop and multiple sessions during the 2017 Regulatory Convergence devoted to examining the new regulations, and RAPS is already working on updating the EU Fundamentals book. Additional RAPS resources can be found online at www.RAPS.org/mdr-ivdr.
Paul Brooks is executive director of RAPS.
Tags: Europe MDR, medical device regulation, new device regulations in Europe