Can we fix / improve the MDR and the IVDR?
Or in other words that I’ve asked on this blog before: can the maker repair what he makes? This blog will argue that he can and he should.
It still happens to me: people that say that the MDR or IVDR is ‘new’. In a way of course they are if you look at things on a cosmic timescale, but in objective terms the MDR or IVDR cannot be seen as new anymore – more as renewing because of the constant stream of MDCG (and to a less extent Commission) guidance to fill in the many gaps and the many amendments that have been adopted to keep the MDR and IVDR projects from derailing. Also, it could be seen as new in the sense of ‘naive’, because crucial elements needed to make the MDR and IVDR work properly have not been put into place, notably Eudamed.
But the MDR and IVDR are already so not new anymore. The Commission is already looking into the future to the date of 26 May 2027, on which it needs to deliver its report according to article 121 MDR and 111 IVDR to
“assess the application of [the MDR / IVDR ] and produce an evaluation report on the progress towards achievement of the objectives contained herein including an assessment of the resources required to implement this Regulation. Special attention shall be given to the traceability of medical devices through the storage, pursuant to [Article 27 MDR / 24 IVDR], of the UDI by economic operators, health institutions and health professionals”.Article 121 MDR / 111 IVDR
Remember that the MDR and IVDR were first proposed on 26 September 2012 (11 years ago almost), entered into force on 26 May 2017 and are applicable since 26 May 2021 and 26 May 2022 respectively. This can hardly been seen as new legislation.
The Commission (DG SANTE) has now tasked EY to conduct a study that may provide part of the factual basis for the article 121 MDR report, the EY-coordinated “Study on Regulatory Governance and Innovation in the field of Medical Devices” conducted on behalf of the DG SANTE of the European Commission, for which I am honoured to function as an advisory group member.
How have the MDR and IVDR been doing?
With hindsight everything is clear and obvious of course. However, from my own experience and legal practice that gives me a statistically relevant view on the medical devices market I can mention a number of points:
- The policy choice of not grandfathering devices and notified bodies, combined with an EU under-resourced process for processing notified body applications for designation under the regulations has caused most of the problems that are ongoing with the MDR and IVDR. That the designation process is still not up to speed is shown by the latest Commission figures that show out of a total of 62 applications for MDR designation since 26 November 2017 39 have been designated and out of a total of 22 IVDR applications since 26 November 2017 only 10 have been designated by 22 August 2023. These figures also show that the notified bodies still underway are mostly held up in the JAT review stage. This has also led to the by now notorious bottlenecks that have led to the MDR first having been delayed in becoming applicable and fat-going changes to the transitional regimes in the sense that the already complex legacy device situation became a lot more complicated. This added complexity is supposed to function as a pressure valve for the notified bodies but creates other problems because by now the transitional regime is so complicated that you need Commission Guidance (already in version 2) and Commission provided flowcharts to understand it, and needs to be explained to third country authorities who really don’t understand anymore.
- The MDR and IVDR were built on the assumption that the data flowing through Eudamed would provide the backbone of the regulations. With more than eight years past entry into force of the regulations we are still not close to full functionality and mandatory application of Eudamed. What has arisen is a confusing patchwork of practices and policies by national competent authorities and notified bodies to utilise what parts of Eudamed are already online for use on a voluntary basis, and make that use mandatory in different ways, or diverge completely by setting up national databases and/or expanding existing systems.
- The continuous adaption of MDCG guidance of which the authorities expect stakeholders to follow this without transition period and to the letter has made the MDR a moving target for notified bodies and economic operators. Also, implementing de facto binding rules by means of guidance is very much at odds with proper legislative procedure in a democratic society. The process of adoption of guidance has often been without due regard to stakeholder feedback and development of guidance intended with legal effect by non-lawyers (MDCG). This has led to guidance having been adopted that is ambiguous, sometimes manifestly wrong (PRRC – referring to EU instead of Union), created new obligations (MDCG 2021-27 on 2nd importer), perpetuated confusion caused by translation issues in other guidance (MDCG 2021-27 on placing on the market) or was adopted and applied regardless of its rejection of core principles by multiple member states (2022-5 on borderlines).
- The MDR and IVDR have not solved a number of issues under the directives, specifically the problem that decisions with binding legal effect exercising delegated state authority (certification as a condition for market access) are taken without proper legal procedure and without proper legal review rights.
- The costs and unpredictability of the route to MDR and IVDR compliance have caused many clients of mine to ‘rationalize’ their portfolios, i.e. decide that certain devices are not or not in the near future going to be on the market in the Union. This is being felt by health institutions, who bitterly complain about this. Data from April 2022 show that more than 50% of the medical devices companies are planning portfolio reductions, affecting 33% of these companies’ devices as planned for discontinuation. For IVDs 17% of today’s IVD total market will be discontinued, of which 50% is discontinued by small and medium sized enterprises (SMEs).
- SMEs turn out to be impacted more by the MDR and IVDR than larger companies, although they represent 95% of the medical devices and IVD manufacturers in Europe. Discontinuation decisions taken by many SMEs largely are based on the expectation that the IVDR remediation cost will outweigh the product revenue. This happens on top of the devices that have already been discontinued since the entry into force of both regulations on 26 May 2017 and regardless of the additional legacy devices expected to be discontinued by the end of the grace periods for the MDR and IVDR in case their transition to the MDR or IVDR is unsuccessful.
- Clients are dropping the customary Europe first strategy (see also the BCG findings last year), because Europe is being outcompeted by regulatory systems for large market that lead to a much quicker and less costly approval (also taking lifetime cost of compliance for devices). Especially manufacturers complex software devices with AI and very innovative devices for which there is limited clinical data available take the decision to go to other markets where they are met with a red carpet rather than a closed door or unpredictable conformity assessment obstacle course.
You could choose to think that if the measures taken to change the MDR and IVDR transitional regimes do their work we just need to power through this temporary difficult period and the situation will ‘normalise’ in the mid term (one of the assumptions of the Joint Implementation Plan for the MDR). This thinking is misguided in my view because the devices industry is one of long term planning and in that sense resembles a coral reef: whatever you destroy of scare away does not grow back quickly or return immediately. Another resemblance is the sensitivity to environmental conditions and human misunderstanding of this (raise temperature 2 degrees Celcius, how bad can it be?). By now most people do realise how bad it can be with coral reefs. It would be a shame if we would need to end up at that point with devices before we realise that the problem really needs solving. I have written on this blog years ago that we could be going down the ATMP regulation road with the MDR and IVDR (the EU regulation that killed the SME markt for tissue, cell and gene therapy by making market access overly complicated, unreliable and costly and I really hate to say ‘told you so’ but the data for MDR and IVDR is showing that exactly this development is going on and catching momentum. As MedTech Europe concludes: “MDR is currently a disincentive against launching medical device innovation in the EU.” This is absolutely not where we would like to be with medical devices policy for the Union.
Yes, the MDR and IVDR are a step up from the directives, but looking back I cannot personally say that I think that they have performed according to expectations. While they have been made as well as they could be made (yes, Bladerunner reference) they have not been implemented as well as they could be implemented.
But, we will see what the Commission concludes in 2027.
We should not forget that the functioning of the MDR and IVDR is not an abstract concept without consequences in the real world – don’t forget that we are all (potential) patients or users of devices. A malfunctioning MDR and IVDR impact innovation in medical devices and impact individual patient health: a treatment may not be available because the device is not available, which impact the quality of healthcare. There is a growing body of data collected by MedTech Europe that shows that innovation, patients and the quality of healthcare are suffering as a result of the sub-optimal functioning of the MDR and IVDR.
The BVMed and VDGH White paper on the Future Development of the MDR and IVDR
The question is if we can afford to wait until 2027 with starting a dialogue about how the MDR and IVDR have been performing, and whether they need any tweaks to make them work better, when the writing is on the wall already. Data collected and reported about the MDR and the IVDR by MedTech Europe published paint a pretty grim picture [link to reports], both as regards availability of devices in the Union in the near and mid-term future and as regards the innovation climate for the medical technology industry in the Union.
To make something stagnant move again, you sometimes have to cause some waves. BVMed and VDHG, the German industry associations for medical devices and IVDs, have just published white paper with the aim to a start discussion on how to make the MDR and IVDR can be made future-proof beyond the quick fixes and ‘delays’ by proposing potential options for the further development of the regulatory system for medical devices after the final transition from the Directives to MDR and IVDR and ensure their full implementation, in the short, mid and long term.
The white paper was developed, refined, commented on and finished by BVMed and VDHG in cooperation with their members over the course of a few months, during which I have spent an exhilarating time working on it in with the BVMed and VDGH team.
The white paper has gotten significant traction with other medical technology industry associations in other member states too, such as France, Spain, Italy, Spain, Austria, Switzerland and the UK.
I encourage all interested to read the white paper (published today and available here at BVMed and here at VDGH), and I know that it has already been received with interest by the Commission, member states, notified bodies and other stakeholders. The following is not a summary of the white paper, but rather my own personal perspective on its context. This blog therefore does not necessarily reflect BVMed’s or VDGH’s position, but is rather my very personal view on the white paper. The below summary is therefore also a very high level summary, the white paper itself is much richer with details.
The white paper consists of five pillars and is drafted in the ‘problem – context – solution’-model for each subject within a pillar:
- Proposals to amend the regulations with missing elements currently missing, such as a procedure for orphan devices;
- Proposals to increase efficiency of the system and implement principles of good administration;
- Reformation of the standard five-year certification cycle;
- International cooperation and reliance; and
- Centralisation of responsibility.
The MDR and the IVDR are intended to improve healthcare for all patients, yet they do not do justice to all patients because they do not contain regimes for devices for specific groups of patients with very specific conditions, such as rare diseases or a specific age group (pediatric devices). They also do not contain an orphan devices regime. Other jurisdictions with a developed regulatory regime for devices have such procedures, such as the US, China, Japan and Brazil. The lack of an effective regime under the MDR has been observed by clinicians in the CORE-MD project as well, and has been identified as a missed opportunity in a peer reviewed publication authored by several well-known paediatric specialists and a civil servant from the devices unit at the Commission.
Another missing element in the MDR is the option of fast tracking of assessment of specific devices, such as is possible under the highly successful FDA Breakthrough Devices program, which gives priority to review for innovative devices that enable a significant improvement in medical state of art. Other jurisdictions with evolved regulatory systems have similar pathways. The consequence is that in this globalised economy other regulatory systems are outcompeting the EU, which does not only not have similar procedures but also has the problem that the approval procedures it has has become unpredictable in terms of cost and duration. As a result an increasing number of European and other companies is abandoning the ‘Europe first’ strategy for market access that has served the EU very well for decades. The white paper recommends adopting a similar procedure for the Union.
Increase efficiency and principles of good administration
The white paper makes a number of recommendations for improving efficiency of the regulatory approval system, which may be seen as a next step to flank the MDCG 2022-14 position paper measures, of which the effect unfortunately still is not really felt in the system because of the stunted roll-out of these no- legislative measures by the MDCG. As I have explained before on this blog, many of the points in the position paper are fully under control of the MDCG and the member states, or the MDCG is not part of a quick solution because procedures proposed by notified bodies in response to the position paper (such as a harmonised structured dialogue procedure) get held up at the MDCG. In that blog post I have referenced the Titanic and the member states as orchestra on the Titanic, and this still does not seem to have changed with the ponderous and unhurried pace at which the MDCG implements the actions in the position paper.
The proposals made in the white paper are intended to make the implementation and application of the rules more predictable, level the playing field for access to notified bodies and manage the overlap between national legislation and EU level rules better.
A long time point of mine is the implementation of principles of good administration, which should be inherent to any regulatory system as a matter of checks and balances in a democratic society and protection of fundamental rights of citizens. These also overlap largely with WTO recommended good regulatory practices for medical products, which include under this heading ‘legality’ as key elements:
- The regulatory framework should provide the necessary authority, scope and flexibility to safeguard and promote health.
- Delegation of power and responsibilities to various levels of the regulatory system should be clear and explicit.
- Systems should be in place to ensure that regulatory decisions and sanctions can be reviewed.
- The regulatory framework should clearly define the scope and lines of authority of the institutions that form the regulatory system to ensure its integrity.
- The regulatory authority must be held accountable for its actions and decisions to the public, those regulated and the government within a legal framework.
Yet, the MDR and IVDR are seriously lacking in some of these respects and should in my view take a large step to evolve as a serious regulatory system, if only for the reason that the lack of appeal and legal review options is at odds with the EU’s own principles of fundamental rights, as well as with the European Convention of Human Rights to which the EU member states are signatories. These principles require that where state authority affect the rights and obligations of citizens is exercised (you get or are denied a certificate entitling you to market access for your device) this authority must be subject to procedural and substantive controls for exercise of state authority, which it currently is not. The white paper proposes a number of solutions to help the MDR and IVDR evolve to more mature regulation compliant with fundamental rights.
The cornerstone of the MDR and IVDR is the conformity assessment leading to a CE mark. Where notified bodies are needed for the conformity assessment the manufacturer can only declare conformity based on a certificate issued by the notified body. Currently these certificates have a five year validity, which means that – depending on the life cycle of a device – a device will undergo repeated re-certifcation. This is somewhat of an anomaly internationally in the regulation of medical products. The international standard for medicines and medical devices is initial regulatory approval followed by strict PMS over the life time of the device. The MDR and IVDR have implemented a system in which all of this happens (especially world class PMS, which is also a significant investment in terms of time and resources) but in addition the market approval is revisited every five years, adding massively to cost of compliance but also to administration required to process these repeat certifications of products with a spotless PMS record. For the authorities this is fine, as supervision is outsourced to notified bodies this way, but for industry this leads to growing problems – especially for devices that are not huge blockbusters. Under normal circumstances re-certification could be OK, but we are faced with capacity restrictions for years to come as a result of the massive amount of legacy devices that still need to be assessed for MDR and IVDR certificates.
These issues with the certification cycle and the costs of approval mentioned above come together in an example described in a recent peer reviewed publication of certain paediatric atrioseptomy catheters for which cost of regulatory assessment in Europe is €135 844 every 5 years compared to €3030 for the lifetime market access in the USA].
For these reasons the white paper proposes to rely more on the increased PMS controls and their surveillance by notified bodies under the MDR and IVDR rather than stick to the current certification cycle, which imposes a significant burden on the system in terms of costs and time. Such a cycle would be justified in other sectors to which CE marking applies because these regulations invariably are not subject to the same intense notified body surveilled PMS and PMCF/PMPF, but rather rely on market surveillance by competent authorities.
International cooperation and reliance
Since most devices are identical across the globe, international cooperation and reliance make a lot of sense. The IMDRF (and its predecessor GHTF) plays an important role in this respect. However, there is much more that the EU can do in terms of furthering recognition- and reliance practices and to promote international convergence of Union regulation. The white paper proposes a number of things, such as countering regulatory fragmentation by exploring revival of the existing EU—US mutual recognition agreement for medical devices (if only for the PMS and vigilance data exchange part) and exploring MRAs with the UK and Switzerland.
The white paper identifies a number of other areas where the EU can step up efforts, such as in serious EU MDSAP participation and recognizing MSDAP audit reports (presently only recognized indirectly, via notified body review).
Centralisation of responsibility
I have joked on occasion that the member states can sometimes be likened to the runners in the famous Monty Python sketch of the 100 meters for people without sense of direction, each runner running off in a different direction at the starting gun. Yet, this is not dissimilar to how the member states operate in the MDCG as a result of the decentralized responsibility that is inherent in the system.
An important example is member states explicitly dissenting with the core principles of important MDCG guidance (such as the definition of the concept of pharmacological mode of action in MDCG 2022-5, one of the most important principles for borderline qualifications – Italy and Germany explicitly distanced themselves, stating in no uncertain terms that
- “The vague definitions do not support effective and aligned implementation of the legislation. Uncertainties among manufacturers, notified bodies and authorities should be avoided. This Guidance does not provide a common understanding of how the MDR should be applied in practice aiming at an effective and harmonised implementation of the legislation.” (Germany)
- “The mode of action to qualify a substance as a medical device or a medicinal product is not sufficiently clear. In particular, the amended definition of “pharmacological means” is insufficient to clarify the issue. Although the introduction of the concept “typically at a molecular level” can help, on the other hand it’s still not enough to a clear application. Moreover the conclusions reported in the guidance in relation to devices incorporating, as an integral part a substance which, if used separately, would/may/can be considered a medicinal product, are controversial causing confusion in the application of the rule. These uncertainties do not help in a proper implementation of the legislation and should be avoided. The guidance does not provide a proper tool to an harmonized implementation of the MDR.” (Italy)
Does this sound like a harmonised approach to borderline devices? Not really. And this is only an example where the member states concerned did choose to publicly and explicitly dissent, rather than just do things differently at national level as is standard operating procedure. For example, during the COVID-19 epidemic certain member states (e.g. The Netherlands) allowed MDR audits to take place remotely, whereas others did not (Germany). There are other examples, like the application of the article 97 MDR / article 92 IVDR exemption for formal non-compliance.
The problem with the decentralized nature of the devices regulatory system in the Union is that nobody seems to feel completely responsible because nobody is. Member states typically ‘wait for Brussels’ when this is opportune, but will at the same time not hesitate to take measures that frustrate matters that Brussels does take up enormously, such as setting up national databases for devices and registration of economic operators where the Commission has asked them not to do this or restricting notified bodies in remote audits where the Commission says this is possible.
Establishing a central accountable managing structure for medical devices would have important advantages over the current system. It would lead to a scenario where good administration is applied to decisions concerning certificate grant and certification status, just like with medicinal products and as is actually required under the EU Charter of Human Rights and the European Convention on Human Rights (ECHR).
I am also specialised in EU pharmaceutical law, which gives me a unique perspective to compare the legal systems for medicines and medical devices. Although also the EU medicinal products regulatory system has its own issues (which is why it is radically revised at the moment to fix these by the way) it is much better developed in the field of legality aspects as referred to in the WTO recommended good regulatory practices for medical products. I often invite people to do the ‘what if this happened in medicines?’ thought experiment, which I have designed especially for politicians and authorities who often do not seem to realise the crucial role of medical technology in healthcare. I notice that especially politicians and civil servants in the ministries tend to see devices policy as something abstract that is outsourced to Europe and the private sector and can be managed on a national level with basically zero resources and low sense of urgency. The experiment confronts people with the harsh reality of regulatory karma: suboptimal rules and suboptimal policy affect everything downstream negatively, and forces one to answer the question if that leads to acceptable outcomes. This thought experiment is quite simple: for every issue with devices regulation and policy ask the question: ‘would we accept this in medicines regulation and policy’? After that first question ask the follow-up question: ‘so why is this acceptable for devices then?’ For example here is a simple one: would we accept for medicines marketing authorisations that there is no fixed duration for an approval procedure or that there is no legal recourse against a decision to decline a marketing authorisation? Of course we don’t accept that. So why do we accept it for devices? You tell me! I’ve been saying from the inception of the MDR and IVDR that this was a missed opportunity.
This experiment is useful for national politicians that often do not seem to realize to what extent they can make a positive difference in Brussels, by supporting harmonization and ensuring that the resources strapped structures function. They can make a positive difference in the MDCG, by making it actually work and to require that makes work of implementing its position papers. The slow implementing of MDCG 2022-14 is a case in point. We are still waiting for quite a number of things to happen that are completely under MDCG (structured dialogues anyone?) or individual member states’ control (they just need to make their own medicines agencies do the work needed).
In any event, whether or not we would accept something for medical devices that we would not accept for medicines, it’s important that the MDR and the IVDR start to function and deliver on their promise. Hopefully I’ll make a contribution to this with my work on the proposals in the BVMed and VDCG white paper and my work in the EY study for the Commission, because Europe deserves world class medical technology regulation. Some things need to be fixed, other things can be improved about the MDR and the IVDR and in my view we should not sit on our collective hands to to capitalise on the low hanging fruit changes.
It’s still not too late to work on this, and not everything needs to happen immediately or all at the same time, which is why the white paper contains a neat table with things to remedy in the short, medium and long term. There is a lot to choose from to improve different parts of the MDR and IVDR. We have a new Commission starting next year that can put its weight behind this. We have European Parliament members who have indicated that mere moving of deadlines is not enough to solve the issues with the MDR and the IVDR. Let’s hope we do not need to have see things get worse before things can get better.
It’s time to give Europe the medical technology regulations that the patients, users and innovators deserve and engage on this with improvements in the short, middle and long term.