Euro Roundup: Legal expert warns about changes to MDR notified body fees
Planned changes to the Medical Device Regulation (MDR) would impose “invalid and unenforceable” fee requirements on notified bodies, according to a legal opinion shared by Team-NB.
The association published a 69-page opinion by Prof. Dr. Ulrich Haltern, LL.M., of the University of Munich, prepared at the request of TÜV Verband. Haltern assessed the legal basis for Article 50 of the European Commission’s proposed update to MDR, which would require notified bodies to accept fee reductions, payment deferrals for micro and small enterprises, and other financial changes.
According to the opinion, the requirements clash with EU legislation on the freedom to run a business. Haltern interference between mandatory fee reductions and pricing autonomy, plus issues with the compelled-acceptance mechanism, while warning that the payment-deferral requirement shifts risks onto notified bodies.
“Taken together, those mechanisms produce a still more serious cumulative interference: notified bodies may be required to charge less, receive payment later, bear greater financial risk, and accept the very engagement that generates those burdens,” according to the opinion.
The paper acknowledged that the goals of the MDR reforms are “legitimate and weighty” and that, in a limited sense, the proposed measures “are capable of contributing to the objectives pursued.” However, Halpern took issue with the means the Commission has chosen to pursue its goals.
Through Article 50, the Commission is using “private notified bodies as the financing mechanism for a policy designed to relieve selected categories of manufacturers,” according to the opinion, which posits that the Commission could have pursued the same objectives through less obtrusive means, such as public compensation, reimbursement, or voucher schemes, and cost-based criteria for fee regulation.
Instead, the Commission will impose “an excessive burden on notified bodies,” Halpern wrote, adding that while notified bodies remain private, for-profit businesses, Article 50 “would make them carry burdens resembling public-service obligations without the public financing, cost-recovery safeguards, or institutional status that normally accompany such obligations.”
Halpern contrasted the MDR proposals with EU pharmaceutical law. Drugmakers benefit from fee relief, for example, for orphan drugs and small businesses, but the financial support is “embedded in a public, cost-based, and institutionally secured framework.” Article 50 adopts parts of the pharma model but omits its financing logic.
While the document is the opinion of one expert, the conclusions suggest that the Commission could face legal challenges if it adopts Article 50. Arguing that the proposals “would not validly empower the Commission to specify the structure and level of notified-body fees,” the paper said implementing acts adopted by authorities would be vulnerable because the legal basis would be defective.
MHRA seeks feedback on planned progressive route to rare disease authorizations
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation on plans to introduce an investigational marketing authorization (IMA) that will change how orphan drugs reach the UK market. IMAs are part of a push to make the UK a global leader in rare disease innovation.
Pitched as a significant regulatory innovation, IMA is a single authorization that combines approval to conduct a clinical trial with a continuously reviewed marketing authorization. MHRA plans to issue IMAs when there are “clear and measurable barriers” to conventional clinical development or to obtaining marketing authorization through existing routes. Companies will need “compelling but limited evidence.”
“The model supports modular data submissions and staged regulatory reviews, allowing decisions to evolve as new data emerge,” MHRA wrote in the draft. “This means that evidence generation, clinical use, and regulatory oversight progress in parallel under a clearly defined framework.”
Safety and efficacy monitoring plans, including reviews of real-world evidence at predefined intervals, will apply to drugs covered by IMAs. The clinical trial methodology will serve as the backbone of evidence generation for IMAs, with optional scientific opinions to aid development and decision-making at key points.
The model allows regulatory activities to happen incrementally as evidence accrues. IMA is designed to help large drugmakers diversify into very rare indications with more iterative investment strategies and a more predictable regulatory environment. The mechanism is also intended to give smaller biotechs and academics earlier regulatory certainty and structured scientific advice.
MHRA’s guidance explicitly supports adaptive and innovative trial designs, such as basket trials, umbrella trials, and hybrid designs incorporating real-world evidence. Surrogate or patient-relevant endpoints may be accepted when conventional endpoints are not feasible. MHRA is open to the use of computational modeling, digital twins, and non-animal methods where scientifically justified.
The agency is accepting feedback on the draft until 30 July.
Press Release, MHRA Consultation, More
MedTech Europe warns Council plans risk creating complexity and regulatory burdens
A medtech trade group has warned that the Council of the European Union’s proposed changes to efforts to simplify digital legislation risk introducing complexity and regulatory burdens.
The Digital Omnibus proposal aims to simplify regulations on data, cybersecurity, privacy, and artificial intelligence. In a statement created with groups representing other industries, MedTech Europe said the proposal “is a concrete and important opportunity to address overlapping, fragmented, and often contradictory rules.”
Yet while the organizations support the intent, they warned that compromise texts drafted by the Council “significantly weaken key simplification goals of the proposal while introducing additional burdens.” The organizations’ concerns include the Council’s rejection of a proposed EU-level system for cyber incident reporting in favor of “fragmented and overlapping national reporting channels.”
“If this trajectory continues, the outcome will fall short of meaningful simplification and represent a missed opportunity, with tangible consequences for Europe’s ability to compete, innovate, and attract investment,” the organizations said. “A course correction is urgently needed.”
In addition to supporting EU-level cyber incident reporting, the organizations called on the Council to maintain the Commission’s targeted changes to data privacy rules, including “an innovation-enabling definition of scientific research.”
MedTech Europe published the joint statement shortly before sharing feedback on the proposed revision of the Cybersecurity Act. The trade group supports the overarching goal of the revision but highlighted a need for measures that “deliver clarity, avoid fragmentation, and remain workable for highly regulated sectors such as healthcare.”
Use of the first four EUDAMED database modules becomes mandatory under MDR and IVDR
The use of four modules in the European Database on Medical Devices (EUDAMED) became mandatory on 28 May.
Established under MDR and the In Vitro Diagnostic Regulation (IVDR), EUDAMED has experienced delays as authorities work to establish a fully functional system. The Commission made progress last year when it declared the functionality of the first four modules and started a six-month transition to mandatory use. The transition period ended on 28 May.
Starting this week, use of the modules on actor registration, UDI/devices registration, notified bodies and certificates, and market surveillance is mandatory. The change means anyone wanting to place medical devices on the EU market must be registered in EUDAMED, in line with MDR and IVDR.
“Mandatory registration supports better oversight of medical devices throughout their lifecycle and strengthens cooperation between manufacturers, notified bodies, national authorities, and the European Commission,” the Commission said. “All operators must ensure that their registration and device information is complete and up to date in the database.”
