Medtech industry calls for major reforms to MDR and IVDR

Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe’s largest medical device trade group, MedTech Europe, said there are fundamental issues within both regulations that can only be addressed through substantial improvements.

Organizations, including MedTech Europe, the European Federation of Pharmaceutical Industries and Associations (EfPIA), and the US-based Advanced Medical Technology Association (AdvaMed) are advocating for the establishment of a single integrated EU body to ensure a consistent interpretation and application of the MDR and IVDR requirements. Additionally, international device makers are proposing the elimination of recertification requirements, saying they are redundant and unnecessary, particularly for lower-risk devices.

These calls were made in response to the EU’s request for public comments on 8 September 2025 regarding potential changes to MDR and IVDR. The European Commission’s aim in hosting the consultation was to identify methods for addressing critical issues faced by the industry due to the regulations. (RELATED: Euro Roundup: Commission consults on changes to MDR, IVDR, Regulatory Focus, 11 September 2025)

Many of these comments were reiterated during an earlier call for public feedback on specific implementation issues related to the MDR and IVDR. (RELATED: Industry groups call for significant reforms to MDR, IVDR, Regulatory Focus 25 March 2025)

The European Parliament adopted the MDR and IVDR in 2017, implementing MDR in May 2021 and IVDR in May 2022. However, both regulations have encountered challenges since their implementation, resulting in several transition periods and delays.

In October 2024, the European Parliament adopted a resolution to update MDR and IVDR to help prevent potential product shortages in the region. This decision came after manufacturers expressed concerns about their ability to meet the deadlines for transitioning their products to comply with the new regulations. (RELATED: EU Parliament passes resolution citing ‘urgent need’ for MDR/IVDR revision, Regulatory Focus 28 October 2024)

The Commission received 441 responses from stakeholders, including industry groups, individual medical device and pharmaceutical companies, notified bodies, regulators, and medical interest groups. Focus reviewed a sample of these comments.

MedTech Europe claims ‘structural problems’ with MDR and IVDR

MedTech Europe is one of the most vocal critics of the MDR and IVDR, calling for comprehensive reforms of both regulations. The group's views are expressed in a series of position papers regarding these problems and suggested reforms.

The organization stated that "after nearly eight years of implementation, the EU medical technology regulations—the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and the Medical Devices Regulation 2017/745/EU (MDR)—have not yet fulfilled their goals of establishing a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic medical devices. This framework is intended to ensure a high level of safety and health while supporting innovation.”

The group observed that there are "structural issues" within both regulatory systems that render the processes slow, unpredictable, costly, and complex, while also lacking agile pathways for innovation. These structural issues cannot be addressed solely by the implementation of IVDR and MDR, MedTech Europe. Significant improvements are needed through both immediate and structural changes to the system.

The group emphasized that a major obstacle to the effective implementation of MDR and IVDR is the substantial administrative burden related to regulatory compliance. They asserted that more than 70% of manufacturers have needed to allocate additional resources to meet the demands of both regulations.

MedTech Europe has identified 83 key sources of administrative burdens associated with IVDR and MDR. They argue that many of these burdens are either unnecessary or inefficient for achieving compliance with regulatory requirements. The identified burdens include the performance evaluation of in vitro diagnostics (IVDs) under the IVDR, clinical evaluations specific to the MDR, assessments by notified bodies, post-market surveillance, the European Medical Device Nomenclature, Unique Device Identification (UDI), and the digitalization of processes.

In the context of performance evaluation requirements under IVDR, the group observed that there is a lack of coordination and harmonization among various ethics committees and regulatory authorities. This situation leads to inconsistencies in requirements and delays in approvals. Additionally, the start date for the mandatory coordinated assessment of multi-country authorizations is too late in the authorization process. As a result, it becomes challenging for sponsors to navigate the different processes and timelines of each country.

In terms of fixing these problems with MDR and IVDR, the group noted in it a paper on future governance that “the regulatory system for [medical devices] and IVDs is overseen and implemented by a number of different actors with overlapping or unclear roles and responsibilities.”

MedTech Europe proposed that the governance of MDR and IVDR be centralized under a single structure at the EU level. This approach would eliminate the fragmentation of responsibilities among various stakeholders. The proposed group would establish a cohesive strategy for the entire medical technology sector in the EU and would oversee the functioning of the European market for all medical technologies, being accountable to European institutions.

AdvaMed: Manufacturers face unpredictable timelines

The Advanced Medical Technology Association (AdvaMed) in the US identified several issues it has with the two regulations.

The group stated that “despite recent progress, manufacturers still face unpredictable timelines and costs in securing device certification in the EU. Different interpretations and implementation of regulations by different Notified Bodies have led to inconsistent outcomes for similar products. A lack of publicly available performance data from Notified Bodies, as well as clear timelines and costs, clouds accountability and makes it difficult for companies to make informed decisions.”

AdvaMed endorsed MedTech Europe's proposal to centralize key tasks and responsibilities for overseeing MDR and IVDR within a new unified structure outlined in the MedTech future proposal paper.

“This governance framework should prioritize patient needs, focusing primarily on ensuring the timely availability of safe and effective devices for patients, healthcare professionals, and health systems. Additionally, it should enhance innovation capacity and improve the competitiveness of the medical technology sector.”

EfPIA: MDR and IVDR have had ‘unforeseen’ effect on medicine development

The European Federation of Pharmaceutical Industries and Associations (EFPIA) commented that the implementation of MDR in May 2021 and the IVDR in May 2022 has had “unforeseen effects” on the development of medicines and the initiation of clinical trials in the EU.

According to a 2023 survey by EfPIA, “A significant number of clinical trials were expected to be delayed, affecting up to 42,200 patients over a period of three years. These regulations are not only blocking access to new treatments for patients with conditions like cancer and rare diseases but also delaying the launch of therapies reaching patients in Europe.”

The group's comments reflect its concern with single integral drug-device combination products, co-packaged drug-device combination products, medicinal products developed for use alongside a companion diagnostic, and medical devices and IVDs used during the clinical development of medicinal products.

EfPIA also recommended the establishment of a single, integrated EU accountable body to ensure a harmonized interpretation and application of MDR/IVDR requirements. "This body should oversee the designation, monitoring, and periodic oversight of NBs, the adoption of EU-wide decisions regarding the interpretation and scope of IVDR and MDR, and the development, issuance, and periodic revision of guidelines, technical documents, and recommendations applicable throughout the EU."

BD, Siemens, Medtronic want to eliminate five-year recertification cycle

At least three companies proposed eliminating the five-year recertification cycle. The MDR and the IVDR establish a certification cycle for devices with a maximum validity of five years.

Becton Dickinson said that “the mandatory 5-year recertification cycle represents a fundamental misunderstanding of continuous device safety management. Recertification creates an illusion of safety oversight while adding no genuine protection, as device modifications are already subject to continuous review through design controls, announced and unannounced surveillance audits and robust post-market surveillance including PMPF/PMCF [post-market clinical follow-up and postmarket clinical follow-up] activities. If safety concerns arise, immediate corrective action is required instead of waiting for the recertification window.”

Siemens said that this recertification affects “unchanged, well-established products with proven safety records.” Such recertification “results in redundant reassessments of documentation already reviewed during initial certification and ongoing surveillance, significantly straining Notified Body (NB) capacity.”

Instead, Siemens recommended that regulators adopt a surveillance-based certification approach, where certificates remain valid based on ongoing market surveillance and audit results, rather than fixed-term recertifications.

Medtronic concurred that the recertification step should be eliminated. The company called the recertification “redundant” with Notified Bodies already conducting ongoing post-market surveillance (PMS) of marketed products.

TÜV SÜD: Notified Bodies are not to blame for bottlenecks

In TÜV SÜD’s comments, the company sought to dispel the notion that notified bodies are to blame for the so-called bottlenecks in the certification process.

“Public perception often misrepresents notified bodies as bottlenecks in the MDR/IVDR certification process. In reality, TÜV SÜD and other notified bodies have built sufficient capacity and have reached a steady operational state. We see that delays are increasingly caused by late or incomplete manufacturer submissions or responses. This leads to underutilization of expert resources and prolongation of certification timelines. TÜV SÜD, as a Notified Body under EU MDR and IVDR, fully supports the Regulations aim to ensure safety, performance and innovation in medical devices. We welcome efforts to improve harmonization, clarity, and efficiency, whilst maintaining patient performance and safety.”

BSI objects to onsite audits

BSI, another notified body, stated that on-site audits are unnecessary under MDR and IVDR for manufacturers facilities with no physical manufacturing activities at that site.

“Annex IX of MDR and IVDR require quality management systems to be conducted on-site for both initial certification and surveillance activities. While this is appropriate for sites having physical manufacturing activities, requiring on-site audits for manufacturers who have no physical manufacturing activities on site is excessive and leads to additional costs for manufacturers and takes up resources for NBs.”

The group recommended that regulations be revised to allow remote or hybrid audits. The group asserted that remote and hybrid audits have created an additional capacity of 2,500 audit days per year for the last three years.

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Medtech industry calls for major reforms to MDR and IVDR

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