Regulatory
The ongoing challenges of MDR compliance
According to Diogo Geraldes, director of regulatory strategy, Europe at Veeva MedTech, manufacturers withdrawing from Europe due to the MDR often do so due to affordability. Allocating resources to conformity assessment with a notified body can cost hundreds of thousands of dollars, while compiling data, including devices’ technical documents and clinical evaluation reports (CER), is resource-intensive.
“The MDR brought up an increased level of scrutiny and barriers towards compliance for entering the market by a fair bit, meaning some devices were not able to meet those requirements,” Geraldes explains. Alongside the EC’s initial slow designation of notified bodies that led to bottlenecks and the EC’s first MDR compliance timeline extension, the narratives around the problems with the regulation are “not necessarily specific to the content of the MDR, but to the way this transition was managed”, according to Dr Royth von Hahn, senior vice-president and global head of medical and health services at notified body TÜV SÜD. The issue at the outset was the EC’s decision not to allow any grandfathering of products from the MDD into the MDR, Hahn says, alongside changes such as increased documentation requirements that have “affected manufacturers and notified bodies alike”. To help with the MDR transition, the EC has been releasing Medical Device Coordination Group (MDCG)- endorsed documents to help stakeholders apply and interpret the regulation. However, these documents have at times held seemingly “contradictory requirements”, Hahn says, thereby adding further confusion for some stakeholders.
“The legal status of these documents is also not very
clear, because it’s not an implementing act; it’s not the law, and different European authorities deal with these guidance documents in different ways,” Hahn adds. Adding to this point, Srivisan notes that a single device can have multiple expectations, depending on which notified body reviews it, and that this inconsistency will make it difficult for manufacturers. In cases where MDR requirements are unclear, Marlene Kießling, senior associate at law firm Clifford Chance, highlights that case law and regulatory practice can provide additional direction. Meanwhile, manufacturers can engage with notified bodies, trade associations or consultants to address compliance questions early, she adds.
Due to ongoing developments of regulatory guidelines and practices, Kießling advises that manufacturers should adopt a “risk-based approach, closely monitor regulatory developments at both EU and national level, and then document key interpretations, decisions and their considerations.” “Obtaining and keeping on file legal advice can help reduce exposure and support interaction with authorities, notified bodies and third parties,” Kießling says.
www.medicaldevice-developments.com
Documentation complexity aside, Hahn notes that capacity at notified bodies, something that added initial strain around achieving MDR compliance, is “no longer an issue”. Compliance remains challenging, however, in part due to various requirement updates by the EC regarding documentation. This has meant that manufacturers have had to put considerable resources towards “updating or creating the necessary clinical evidence and technical documentation required”, Hahn says, with such updates adding burden to notified bodies, too, as they are now required to look at certain documents in a “deeper, slightly different way”, he adds.
The evaluation uptick While not set in stone, the EC’s December 2025 proposal aims to address the MDR’s documentation burden and streamline the overall certification process. Kießling says: “The proposal includes longer validity periods for certificates, extended deadlines for reporting serious incidents, streamlined procedures and greater use of digital processes.” While certain proposals in the policy document would reduce burdens on manufacturers, the EC’s suggested shift to a continuous data-reporting stance would add considerable complexity to the MDR overall. Some manufacturers’ approach to the MDR has been to “throw resources” at it, such as hiring more people to handle it. With the proposed posture shift, however, this approach “may no longer be sustainable”, according to Geraldes.
He says: “The move to a state of continuous compliance means that manufacturers will be expected to maintain compliance across their whole system, meaning the likes of technical documents need to be constantly updated, and live within the European Database on Medical Devices (EUDAMED), not just things fixed in time.”
EUDAMED is viewed as a key constituent of the MDR. Positioned as a “living picture” of the life cycle of medical devices made available in Europe, manufacturers must file various data relating to their devices in this database. The first four modules of EUDAMED, including Unique Device Identifier (UDI)/ and device registration for new devices, and Notified Bodies & Certificates, became legally mandated on 28 May 2026.
“Regarding documents like quality system, complaints and others, manufacturers may think, ‘I’ve done my uploads to EUDAMED, so I’m compliant’, but that’s not really the problem. The biggest problem is going to be maintaining that data and making sure that it is clean,” Geraldes explains. Geraldes’ view is that manufacturers will fundamentally have to reimagine how they operate to meet this shifted reporting posture, with those who embarked upon the MDR process sooner, and with deeper pockets, more likely to be able to pivot and
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