How The MDR Is Making The EU Competitively Backward
Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.
When it comes to guidances supporting the implementation of the Medical Device Regulation, major issues are being created because there is “no real possibility for industry to actively and meaningly engage in drafting EU guidances” and provide input on how to make the new system work efficiently, Elizabeth Gfoeller, corporate director, regulatory affairs at MED-EL, an EU manufacturer of globally marketed hearing loss solutions, told the first day of the meeting on 13 September.
This is one of several issues making Europe “competitively backward” when it comes to the regulation of medtech products, Gfoeller said while representing the manufacturer viewpoint during a panel exploring the regulatory situation in the EU just four months after the full application of the MDR.
In terms of application of guidances, “we are in a very pedantic versus a very pragmatic stage of implementation of the MDR,” Gfoeller said, “and no one wants to do the wrong thing.” Notified body auditors and reviewers are on a steep learning curve as they assess products under the new MDR for the first time, she said.
This is leading to audit and product approval delays and confusion where there is no possibility for industry to respond and suggest alternative approaches, she lamented.
The situation is compounded because, unlike in the US, there is no public consultation on guidances in the EU. Nor is there an official process in the EU where stakeholders can flag issues or gaps in guidances and new processes, she stated.
Guidance Shortfall And Industry Playing Catch-Up
And despite the plethora of guidances that have been issued, Gfoeller says that not all needed guidances are available even now, some four months after the 26 May 2021 MDR application. The Medical Device Coordination Group (MDCG) continues to work on finalizing the documents.
Indeed, because many much-needed guidance documents were not in place at the date of application, there has been a very staccato, stop-start process for notified bodies and manufacturers trying to apply and follow these guidances. This has led to long periods of indecision among notified bodies and manufacturers about how best to apply the regulations while these documents have been pending.
Moreover, each time a new guidance document has been published, manufacturers have been forced to review and update their procedures. In some cases, a new guidance has been published one day and then applied during a notified body review the next day, leaving no time for the company to assimilate the information and reflect the guidance in its processes and documentation.
Inconsistent Yet Pedantic Application Of Guidances
Even with guidances in place, their application by notified bodies is frequently inconsistent, Gfoeller said.
This is made more challenging because, while in theory guidances are not binding, in practice they are being applied in black and white by notified bodies, and “very pedantically” in some cases, the MED-EL director asserted.
She spoke of additional confusion within some of the guidances, giving the example of MDCG 2020-6 which incorrectly states that the terms “intended use” and “intended purpose” mean the same thing.
Also, Gfoeller explained, there is a drive by some authorities to designate previous AIMD devices as Class III by default, even though the MDR rules of classification clearly state that all devices should be classified in their own right.
Such discrepancies and additional workloads create an unnecessary ongoing debate between the manufacturer and the notified body, she said, and limit progress towards conformity assessment.
Gfoeller likened challenges with guidance to one of three storms that her company has been battling while bringing product into compliance with the MDR.
She explained that MED-EL was an early adopter of the MDR, being one of a handful in world to be certified to the MDR in 2020. At that time, she said, the company was able to have reviews despite most guidance documents not being available. It was a combination of “best guess and best practice,” she said.
The company’s first quality management certificates covering many product scopes and several product certificates were issued under the MDR in March 2020. It passed its first MDR audit in November 2019, so there was a long delay from the audit until the certificate was issued for the QMS given all the teething challenges, Gfoeller explained.
“We knew it would be challenging,” she said, but the company had expected to cope well because it was a highly reviewed and scrutinized high-risk device manufacturer. She added: “Five years on, we are a bit bruised and less naïve.”
Inexperienced Reviewers and Clunky Conformity Assessments
What MED-EL has discovered is that “change is the only constant with MDR.”
The issues of ongoing change and the newness of the system have made progress towards conformity assessment “slow and cumbersome,” Gfoeller added.
She said that progress is made even more difficult because the company has been “frequently encountering inexperienced review teams in the context of an immature system where reviews have been fraught with massive learning curves for our company and on the notified body side.”
The lack of predictability both within the notified body and between the notified bodies means that our “timelines for projects are all over the place and remain so,” she lamented, referring to this as a second of three big storms that MED-EL has been dealing with.
Notified Body Capacity Issues
The third big storm that has thrown challenges in the way of the company is the lack of capacity at notified bodies. With many new recruits and the steep learning curve, this is leading to delay, increased timelines and rising costs for industry.
Notified bodies are under an immense amount of external pressure from authorities, with many showing points of strain already.
While many new recruits have been hired, their inexperience can cause further problems just as all notified body personnel, along with manufacturers, are playing catch-up with new guidances, realizing the rules are not always logical but have to be applied anyway.
What this means is that right now, the EU has a very unpredictable, and at times chaotic, complex system which is trying to lurch to get on its feet.
“This is very unfortunate given that we are only in 2021 – and we all know that the big wave is coming in 2023/24,” Gfoeller said, referring to the upcoming 26 May 2024 date by which all products will have to fully comply with the MDR. That includes products that will have benefited from the “grace period” rules allowing them to remain on the market under the former directives.
The Way Forward
In Gfoeller’s view, the MDR needs cool, calm objective inputs and decisions to settle the MDR system down and dispel the storms. Patients and their continued access to safe and effective devices must be the driving wind, she said.
Having had experience getting conformity assessment certificates under the MDR during this time of the MDR infancy, she recommends that notified bodies should be more focused on the risk and benefits that devices offer to patients and be less pedantic in the way they apply the text.
“We need a clear more predictable pathway to approval in Europe,” she said. Reviewers should be able to be specific as to why a review would get a deficiency and state what is missing or wrong. But that is not happening at the moment, as such feedback is considered “consulting” which NB are not allowed to do. And this means it is more difficult, time-consuming and expensive for manufacturers to understand the deficiency sufficiently to resolve it and receive approval.
“We need to return to the common-sense European approach based on a risk assessment and proportionality. We need to make sure the European system has a flexible, quick, understandable, and efficient pathway to market and make it competitively attractive internationally again,” Gfoeller stressed.
She also called for allowing pre-submission meeting possibilities and opening other approval pathways in the EU such as the breakthrough pathway, humanitarian device exemption and compassionate use options, which exist in other major markets such as the US, Japan, China.
A focus on facilitating access to the EU, Gfoeller explained, will help attract new technologies to Europe and serve unmet patient needs.