The appointment of notified bodies is arguably the most pivotal part of the implementation of the EU's new Medical Device Regulations, but it is also the area where there seems to be the least clarity.
The device and diagnostics industry wants to know how many notified bodies there are going to be, and what their capacity will be and what the timing of their designations will be so companies can plan regulatory strategies. But this information is only partially available and sometimes solely based on rumors.
There are constant gripes that there is not enough transparency, so Medtech Insight spoke to Oliver Bisazza, director of regulations and industry policy at trade association MedTech Europe in Brussels, to find out what insight he has on the issue.
"One of the reasons the notified body issue is so key is that it affects whether there is enough time for recertification of existing products. The concerns are definitely real."
In a separate article, Bisazza discussed particular concerns with the first-come, first-served schedule of notified body designation decisions. (Also see "How Notified Body Notifications Could Handicap Parts Of The Medtech Industry" - Medtech Insight, 23 Feb, 2018.) Below, is a broader discussion on notified body appointments.
While questions continue to abound, industry will be relieved to hear that some member states are committing more resources to help process notified bodies through to designation, and there are plans for new notified bodies to be set up. But there needs to be clarification around not only notified body numbers and capacity, but also the timing of notified body designations, the potential application of the extension derogation, and the possibility of pilot audits, for example, Bisazza says.
Questions put to Bisazza on these topics and his responses follow below.
Timing Of Appointment Of Notified Bodies
Medtech Insight: How soon do you think the earliest notified bodies will be appointed, and at what rate will they continue to be appointed?
Oliver Bisazza: We are pressing the Commission, member state authorities, and notified bodies to do all they can to ensure notified body designations happen as soon as possible, to the highest standards possible and to communicate when the notified bodies will be ready to begin working with manufacturers.
The timeline put forward by the Notified Bodies Operations Group (NBOG) suggests notified body designations may not happen until 26 July 2019. That is just 10 months before the May 26, 2020, date of application for the MDR and two years, 10 months before the May 26, 2022, date of application of the IVDR. While this may be guess work, and we are hopeful some designations may occur before this, equally we are aware that some will take longer.
There is a real sense of urgency as the time left for manufacturers to be audited by notified bodies is looking unreasonably short. At one time, it seemed that there was going to be a transition period of three years. But if you have hundreds of thousands of products going through the system in what may be little more than nine months instead of three years, as may now happen, then this is going to overload the system. The consequence is likely to be that a significant proportion of manufacturers will be unable to meet the deadlines and products may need to be removed from the market, or otherwise have their certification postponed to a later date.
The later notified bodies become available, the more uncertainty and ability to plan and the less time manufacturers will have to recertify their products. To wait 18 months until designation is too late to maintain business confidence.
How real are the concerns that there will be a failure to (re)certify existing products in time under the current medical device directives or the MDR/IVDR because of notified body capacity issues, and these products will then need to be removed from the marketplace?
Bisazza: One of the reasons the notified body issue is so key is that it affects whether there is enough time for recertification of existing products. The concerns are definitely real. But the concerns are less about the entire industry, and more about certain parts of industry because of the breadth of coverage that results from the early notified body designations
. For instance, notified bodies competent in the area of diabetes therapies might hypothetically become available first, but what if it takes many more months before notified bodies competent in the area of orthopedic implants become available?
If there is not enough time for certification, the fear is that certain legacy products will be retired, voluntarily, by the manufacturers. The question is how do companies manage a huge workload in limited time? Either you find more time or more capacity or reduce workload by retiring or postponing the recertification of existing products because costs are too high and margins too low.
Won't the derogation, under the new regulations, that introduces an extension for already CE-marked products help?
Bisazza: The option to recertify these products one more time under the directives is an essential part of our transition periods. In theory, between May 26, 2020, and May 27, 2024, under the MDR and May 26, 2022, and May 27, 2024, under the IVDR, companies which meet certain conditions and whose products are certified against the current directives may continue to place these CE-marked products on the market.
That is the theory, but in practice there are a number of significant limitations and we need a great deal more clarity about the conditions providing companies entitlement to use it, so that companies can really rely on it and plan around it during the transition period. For instance, this derogation is only an option for those products that are subject to notified body supervision under the Directives – in the case of IVDs, this is 15-20% of all IVDs at best.
"From what I have understood ... notified bodies can do pilots audits under the new Regulations."
Can notified bodies do pilot audits of companies so that everyone gets a head start?
Bisazza: From what I have understood from the notified body session at our MedTech Forum, notified bodies can do pilots audits under the new Regulations – but only once they have been designated and notified against those Regulations.
The European Commission will not allow notified bodies to do pilots in any official capacity before receiving their designation and notification under the new Regulations. But there are a lot of further questions surrounding the working relationship between companies and their notified bodies which are currently under discussion. Other issues include, consultancy, for example, which is not allowed.
But what defines consultancy, and must consultancy services be removed outright from the notified bod services or can they legally still exist provided they are a completely separate part of the business?
When we spoke in November
, you emphasized that was important for a sufficient amount of "ambition and resources" to be thrown at the challenge by authorities. Has it?
Bisazza: No, not yet. We want to know if the Commission and member state authorities who assess and designate notified bodies are at least willing to attempt faster timelines than 18 months despite their challenges and resource limitations.
Indeed, it is a mixed bag in terms of responses when it comes to additional investment at authority level towards joint assessments of notified bodies towards designation. We have been reassured multiple times across the board that authorities are taking this challenge seriously and that some, at least, are trying to devote more resources to these problems.
But, we do not know how many auditors' member states have made available to the joint assessment audits. I have been told it is it is "an optimistically high number". This is good news as it means that the designation of notified bodies could go more quickly. But if more auditors are being made available, why are we not being informed of how much capacity there will be and how many notified bodies can be assessed in parallel? Transparency about this could go a long way to preserving business confidence.
Are member states increasing their overall medtech workforces to better manage the implementation of the new Regulations?
Bisazza: We are aware that some member states authorities are significantly increasing the size of their internal workforces to cope with the greater size of the regulations when compared to the medical device directives.
Although I cannot reveal which they are, we have heard that both smaller and bigger authorities are among them. But, we are also aware it is not happening across board. I have even heard of at least one member state that is unable or is either reducing or not replacing staff. That is very disappointing when we are clearly calling for investment in people, time and resources commensurate with the size of the regulations.
"We are also hearing about potential new notified bodies that may be created in some countries in partnership with the state."
Numbers of notified bodies
There has been a lot of talk about notified body numbers dropping, but, as of early this month, they have bounced back from 55 in May 2017 to 58 under the MDD just recently. What do you think this is a sign of?
Bisazza: The Nando database has been quite out of date for a while, so this change in numbers could be due to corrections, rather than new designations. That said, we are hearing all the time about new players entering the space – both from within Europe and outside. This is encouraging. We remain optimistic that this trend towards creating new notified bodies will bode well for future capacity but the main issue is not just that new notified bodies are appearing, it is about how much capacity they will bring, which technology areas they will specialize in and how soon they will be available.
We are also hearing about potential new notified bodies that may be created in some countries in partnership with the state. Bear in mind that many notified bodies are private players, but not all of them. There is no obligation for them to be private – what matters is that they are independent. These new players may be needed in countries where either a notified body does not exist and there is a need for it or ones where a notified body does exist but is understood to be disappearing. The aim is to fill gaps that remain and to give local industry a service in their language and to offer them someone who understands the local environment. There are several notified bodies that are still linked in one way or another to the government. I understand this still applies, for example, to notified bodies in Portugal, Spain, Italy and Ireland and potentially others.
To your knowledge, how many notified bodies that are not members of TEAM-NB have already applied to be designated under the MDR or IVDR?
Bisazza: We are still seeking out this granular information but there are many conflicting rumors. We hope to know more soon. We would welcome a scenario in which the authorities make this transparent. I understand this is not yet on the table but it would go some way to reassuring the industry about what is happening.
Timing and derogation
To what extent does the FAQ paper put out by a subgroup of the European Commission's Competent Authorities for Medical Devices Group (CAMD) provide clarity about how companies can make use of the derogation allowing products CE-marked under the directives up until the last minute before full application of the MDR/IVDR to remain on the market for considerably longer?
Bisazza: While the FAQ document published by the CAMD answers a lot of questions about companies' ability to use the transition period, not everything is made clear yet in that document. The more we can iron out, the more companies will have confidence in this transition period and be able to plan around it.
One of biggest areas is the concept of "significant design change." Companies who wish to rely on the derogation for an extension to May 2024 can do so but during that time they can't make significant design changes to the product. We need to know very clearly what is and what isn't a "significant design change" – a concept that regulators have been working on and off for decades and never, in my opinion, in a completely harmonized manner. Clarity is needed for this to be a viable option.
The other consideration in terms of deciding whether or not to use the derogation for an extension is to remember that decisions around the CE marking of medical devices and IVDs can have international implications. The CE marking often opens up access to other markets. But this also comes with consequences: when you need to change CE marking by recertifying to the Regulation, that can create work in the international markets. You may need to re-register or re-notify the other markets’ authorities. That is a consideration that companies want to work around. They might postpone or deprioritize the recertification of existing products to also postpone the work that would need to be done beyond the EU. Having enough time to do all of this in a logical fashion is essential.
With so many concerns that the new system is not going to be up and running sufficiently well in time, how much talk is there about the need for extra extensions to the deadlines beyond the four to five year extension in the Regulation with the added conditions?
Bisazza: We hear rumors all the time but I have never heard any authority propose in any official context an extension of the deadlines. My understanding is that modifying the transitional provisions, just like modifying any other parts of the legal texts, would require reopening the text and taking it back to the Council of the EU and to Parliament.
Bisazza: As for the CAMD subgroup, my understanding was that their main task was to deliver the FAQ. Then, management of the transition at a higher strategic level would have to be driven by the full CAMD or even the Medical Devices Coordination Group. [MDCG - which supports the Commission with implementation, among other things.] We noted with much interest that the final version of the roadmap included a whole new work stream 8, dealing with Overarching and Cross-Cutting Priorities. Work stream 8.1 talks specially about contingency planning during the transition if it turns out to be untenable because of the absence of certain actors. It seems to be for the full CAMD to work on that.