Experts hope MDR, IVDR reforms will improve predictability, reduce burdens

ROTTERDAM, NETHERLANDS — A panel of experts representing industry, notified bodies, and regulators said they hope upcoming reforms to the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) bring greater consistency and predictability for stakeholders, while addressing costly administrative burdens.

The experts delivered these remarks during the opening plenary session of RAPS’ European Lifecycle Management Conference on 28 October.

Royth von Hahn, senior vice president of global medical health services at TÜV SÜD Germany, noted that it's been eight years since MDR was first enacted, which is around one third of the time that the Medical Devices Directive (MDD) was in effect. However, he noted that stakeholders are still talking about MDR as something new, which shows how difficult the implementation has been.

Von Hahn said there were two significant problems with MDR from the start – the content and structure of the legislation and the way it was transitioned from the MDD, which took effect on the whole market at once and required certifications from scratch.

"We need to look at the substantial cost drivers, and in the end, we are talking about cost, everything you can translate to cost," said von Hahn. "On an abstract level... It's missing consistency, it's missing predictability... and it's the administrative burden.

"Our technical experts are spending 40% of their time doing administrative stuff, documentation, and coordination in the product projects," he added. "That is not the best use of what these people are educated for and how they want to really use their expertise and look at the risk of products."

Ultimately, von Hahn hopes the reforms will address the cost drivers to make things easier and faster for all involved.

Jana Russo, medical devices manager at MedTech Europe, echoed several of von Hahn’s concerns and said Medtech Europe also has asks in terms of the reforms they would like to see in December that would address efficiency, innovation, and governance. In terms of efficiency, she said they would like to see a reduction of administrative burdens by eliminating tasks that don't add value and improve patient safety.

"We could think about, for instance, reporting obligations, having to submit vigilance reporting to competent authorities, but also to notified bodies," said Russo, "We could think about recertification, where it doesn't really add so much value to the process."

She said there are ways to drive innovation through efficiency. She noted that regulators, medical societies, industry, and notified bodies have collaborated on developing guidance and a pathway to bring orphan devices to market more efficiently, but they need to go further.

"We need also a pathway for other special types of devices," said Russo. "We need a pathway for breakthrough innovation... We are again actively involved in contributing as a stakeholder to the MDCG guidance on breakthrough innovation, but we also feel that this should be addressed in the legislation as well to have a proper framework."

Furthermore, Russo said the reforms should improve the governance structure to foster predictability and clarity for manufacturers. She said the current system is too fragmented and has many diverging opinions.

"We have the European Commission, the independent authorities, and MDCG, but there's no one single responsible entity for the devices getting into the market and getting to the patients," said Russo. "This is something that we feel is really the core problem and that needs to be addressed if we are to see the current challenges alleviated.

"We really are advocating for a thorough reform of our system," she added. "We have not seen the revision proposal, so we do not know how that is being addressed [but] we are very much hopeful that it will be addressed."

Gearóid O'Connor, a medical officer at the Irish Health Products Regulatory Authority (HPRA) said MDR has resulted in better traceability and transparency of medical devices, notified body reforms, and pathways for specific types of devices. However, he acknowledged that there is a need for changes and there's hope that the reforms could potentially reduce administrative burdens, provide regulatory clarifications, and bring more competition and innovation to the medical device market to benefit patients.

"We'd like to see more adaptive and specific pathways for specific types of devices," said O'Connor. "We'd like to see a reduction in the burden and the kind of unnecessary administrative requirements to manufacturers, that doesn't mean stripping out wide parts of the legislation without caution, because that could impact patient safety and patient care, but we do acknowledge there is some burden that can be reduced.

"Costs need to be fair, they need to be justifiable, they need to be transparent," he added. "There needs to be a greater addition of scientific rationale behind the kind of implementation of regulation."

While the reforms are important, O'Connor said that it's more important to ensure the changes can be implemented.

"There's a lot to be said that MDR is a long way from being currently implemented, even as it currently stands," he said. "There needs to be an investment in the infrastructure, there needs to be a commitment to implementing the new regulation, and there needs to be a focus on scientific expertise and a greater operational coordination amongst the entire environment."

Tom Melvin, an associate professor of medical device regulatory affairs at Trinity College Dublin and the regulatory affairs chair of the Biomedical Alliance in Europe, said that some of the issues raised by medical device experts, such as the implementation of clinical data management regulations and clinical and scientific expertise resources, were raised as far back as the early 2000s.

"Although we have expert panels now, as well as many more activities and notified bodies with things like structured dialog, I think what we really have to do in Europe is to figure out how to have a small but appropriate number of clinical and scientific expertise working on behalf of Europe, because right now, things can be very siloed," he said. "We have to figure out how to do things like deliver advice, guidance and specifications coming from a central European source, because this will help us to make clinical evidence pathways clearer."

Melvin hopes the proposed reforms can facilitate more regulatory advice in product development. Unlike in Europe, he noted that researchers and product developers can often engage with the US Food and Drug Administration (EMA) early through pre-submission meetings to address issues such as study designs and endpoints that can empower them and attract research funding.

"That kind of certainty is not really there in Europe, because you can't get that clear type of clinical advice at the critical time when it's needed," he added.

Melvin also said that in-house IVDs used by hospital laboratories, especially to diagnose rare diseases and used for precision medicine, are critical to patient care, but face significant regulatory challenges which he hopes will be addressed in the reforms.

"Hopefully, Article 5 of IVDR will be subject to a significant revision, because we really have to better empower these diagnostics labs," he said. "Everything is very well-controlled; there's batch and product verification under strict quality management systems.

"It's happening safely at the lab level, but they have a lot of challenges with complying with Article 5," he added.

Silvy da Rocha Dias, head of the office for expert panels and groups at the European Medicines Agency (EMA), said regulators have already implemented specific changes to ensure expert panels operate effectively and can help implement MDR as it currently stands and any future reforms. She noted that some of that has been thanks to pilot programs, such as when panels directly advise manufacturers about their product clinical strategies and investigations, which mainly address methodological issues and study designs. She said they are also looking to implement a pilot program next year to allow manufacturers to receive parallel advice from Health Technology Assessment (HTA) bodies to help streamline and accelerate product development.

Da Rocha Dias also mentioned that they have pilot expert panels for pediatric and orphan diseases, which they plan to roll out as standard procedures next year as well.

There's a lot that panels can do. They are already very active at the moment," said da Rocha Dias. "I don't think it's that visible, because we're a little bit behind the scenes, and it is a small part of the MDR that we are implementing, but anything that requires scientific expertise, medical expertise, we do have it as well, with the expert panels, and it is complementary with notified bodies."

Nebojsa Serafimovic, medical device assessor and senior expert at the Austrian Agency for Health and Food Safety (AGES), said that the Commission is going full speed to conduct its targeted evaluation of MDR and IVDR, noting that it has canceled meetings and is working overtime to develop proposed reforms by December. While he's not at liberty to discuss the reforms his colleagues are working on, he highlighted that the subsequent obligatory evaluation of MDR is scheduled for 2027, which means the proposed reforms have a very short period before being reevaluated.

RAPS European Lifecycle Management Conference

Experts hope MDR, IVDR reforms will improve predictability, reduce burdens

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