One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), experts within the industry continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.
As always with the introduction of new regulations, there are early adopters who recognize that it is crucial to engage with the requirements sooner rather than later. This is especially true for the MDR and IVDR given the expected capacity limitation of notified bodies as we approach the application date.
Yet as the new MDR does not grandfather devices that are already CE marked, the Competent Authorities for Medical Devices (CAMD) is still working on the rollout of its roadmap to assist manufacturers during this transition stage. Many suggest that progress is not happening fast enough and little guidance is readily available.
Some experts maintain that the MDR and IVDR expectations have been clear for long enough and that sufficient public information is available, insisting that companies could (and should) have started earlier. But there are still calls for more clarity and concerns that precious resources aren’t being applied appropriately or efficiently.
Industry and Institutions
Healthcare institutions, for example, seem underprepared which is concerning seeing as they will no doubt experience significant changes under the MDR and particularly, under the IVDR.
Many healthcare institutions make and use their own homebrew IVDs. These tests are exempted from the current IVD directive, but the new IVDR has a regime for such tests, which also does not grandfather existing ones. This means that all homebrew IVDs on the market must meet the new IVDR requirements by May 2022.
The medical software industry is also facing big changes due to the new classification rule for standalone software. Most decision-support software and monitoring and diagnostic software will now fall into Class IIa or higher and must be certified by a notified body (as opposed to most currently self-certified as Class I under the MDD). The software will also be subject to a full quality system requirement, which puts added pressure on manufacturers during this transition stage. Manufacturers of class I software are not allowed to rely on the soft transition period and must be ready with CE certification by a notified body by May 2020.
Given the bottleneck in notified body capacity and their lack of software experience (since under the MDD they may not have focused in so much detail on software), these manufacturers face a real challenge. Class I reusable surgical instrument manufacturers are also expected to incur additional regulatory burdens as cleaning and desterilization validations and instructions must now be reviewed by a notified body and certified.
In addition, the new classification rule 19 on nanoparticles could have a big effect on industries where devices are made by milling, as the results of exposure studies on nanoparticles can lead to a higher classification of such devices. It is clear that some manufacturers, mostly in the dental sector, are completely unprepared for this.
Finally, the IVD industry has the same problem as the software industry where most IVDs are currently self-certified and under the IVDR the large majority must be CE certified by a notified body. This, along with the lagging number of applications for accreditation under the IVDR by notified bodies, is likely to lead to bottlenecks towards the end of the transition period for the IVDR.
The Bottleneck Effect
In an industry that requires certification of such a large number of products for the very first time, there are likely to be notified body shortages and severe capacity limitations which put pressure on those who have re-designated and will increase workloads.
Bottlenecks expected within the system will potentially mean that some companies may not be ready to sell certain devices for a period of time after May 2020 because their MDR certificates will not have been granted in time. Issues could arise from companies engaging in portfolio rationalization leading to some devices becoming unavailable without immediate substitutes that hospitals could use.
If a manufacturer does not receive the MDR CE certificate in time and does not manage to implement a plan B (temporary extension of existing MDD, AIMDD, or IVDD certificate, or frontloading of the EU supply chain to bridge a period of not being able to place new product on the market), several things could happen. The manufacturer will not able to place new products on the market and its cash flow and market share in the EU could be undermined. Competitors could take advantage of this and immediately acquire market share, which would take time to regain once a company recovers from the delays. In addition, not having a valid CE mark (even temporarily) could disrupt extra-EU markets where they rely on CE as a passport for access to their markets.
With the potential for such constrained movements in the EU market, it is feared that innovation in the industry could slow down and manufacturers may be tempted away from the EU to prioritize other markets, such as the United States, where it may now be easier to achieve reliable market clearance.
There is the potential for tensions between notified bodies and manufacturers and some notified bodies may consider actions that are not in the best interests of their current customers: choosing closure in a controlled manner, withdrawal, applying for more limited designations or only applying for MDR or IVDR designation for some of their notified body entities (if they are in a group that has multiple notified bodies in different jurisdictions).
Maintaining Good Practice
Where a notified body does not have sufficient capacity to schedule the required conformity assessment activity, there may be a resulting increase in fees in favor of larger manufacturers. Monitoring to ensure equal access to notified body services by all manufacturers, whether large or small, is critical to the European medical devices ecosystem.
Despite notified bodies acting on delegated authority when issuing and managing CE certificates, manufacturers of medical devices have little to no legal recourse against perceived inappropriate business practices and some Member States may view this as a ‘market’ problem that will self-correct. With the increasing panic as the application date of the MDR and IVDR approaches, we can only hope that notified bodies play fairly with all manufacturers.
Any degradation in notified body practices would damage the legitimacy of the CE system for medical devices and given that both the MDR and IVDR explicitly require fair and balanced contract terms from notified bodies, member states have a duty to crack down more on malpractice.
While it is still very hard to predict the readiness of all stakeholders, including the European Commission, member states, notified bodies, and manufacturers, the Commission is working with confidence that the current system is sufficiently robust and staffed to ensure that there will be enough notified bodies certified under the MDR and IVDR and that the essential elements of the Eudamed database will be ready in time.
One consideration that the Commission has no control over is the quality of the applications submitted by notified bodies for designation under the MDR and IVDR. The notification process may be delayed or extended, require significantly more resources if the notified body concerned takes considerable time to fix inadequate applications or address non-conformities raised in the audits of notified bodies with appropriate corrective actions. All of which absorbs more of the limited member state and notified body resources.
The Commission and the member states, while undoubtedly concerned, do not have a direct and specific legal obligation to ensure that there is sufficient notified body capacity available. This means that it is crucial for manufacturers to not only ensure that they have their own houses in order, but also that their notified body of choice is similarly prepared.
Member states must have sufficient resources and strategies to assist manufacturers that are disrupted and invalidated by underperforming notified bodies. Given the lean staffing of medical device authorities in some member states, there are concerns about whether they will be able to deal with orphaned manufacturers and manufacturers of essential devices to the healthcare system that are unable to obtain MDR and IVDR certificates in time as a result of bottlenecks at their notified body.
Also, member states must be prepared to issue the Single Registration Numbers for Eudamed in time as this is a gating issue for progress under the MDR or IVDR. And finally, manufacturers have to be ready to submit high-quality dossiers for MDR IVDR certification as early as possible. To make that happen, they must make sure that they are well informed, aware of the latest interpretations of expectations (a significant manufacturer, notified body, and member state calibration challenge) and minimizing concern over how complicated everything is.
Most of the technical files and supporting data for the self-certified IVDs currently on the market show large gaps that must be bridged to meet IVDR requirements for performance evaluation. Most of the currently self-declared IVDs will need a notified body CE certificate under the IVDR as a result of the new classification rules. As a result, the IVD industry is in for quite a quantum leap and it is expected that there will be a regulatory turbulence that will be much more dramatic than that for devices under the MDR. This is because it is anticipated that there will be relatively less notified body capacity available for phasing in devices currently on the market than is available under the MDR. With such a steep learning curve for many IVD companies, the concern is they will leave it until much too late to begin implementing remediation plans.
The Regulatory Affairs Professionals Society (RAPS) and TOPRA will deliver a workshop in Brussels on Nov. 20 to help regulatory professionals understand the impact of the new MDR on combination products. Click here for more information or to register.
Paul Brooks is executive director at RAPS and has more than 25 years of experience within the medical device regulatory affairs environment. Erik Vollebregt co-authored this piece. Vollebregt is with Axon Science Based Lawyers and he specializes in EU and national legal and regulatory issues related to medical devices.