European Commission Proposes Regulation to Simplify MDR and IVDR

On 16 December 2025, the European Commission published a legislative proposal to simplify and reduce the burden of the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). The proposal responds to strain that has built since the two regulations took effect: administrative burdens, Notified Body capacity shortages, and unpredictable certification timelines have delayed market access for innovative therapies, pressured small manufacturers financially, and in some cases pushed legacy devices out of the European market. The original goal of the MDR and IVDR, a transparent framework that protects patient safety and product traceability, remains widely supported; this proposal targets how that framework is implemented, not its purpose.

This proposal is relevant now because the MedTech sector is approaching several transition deadlines. Manufacturers should not wait for the legislation to be finalized before assessing its impact: the changes will affect compliance strategy, clinical data generation, and post-market surveillance obligations in the coming years.

This article covers the proposal’s core elements: what it changes, how it fits into the EU’s legislative framework, and how it affects medical device manufacturers. Key areas include eliminating the five-year certificate validity limit, easing requirements for the Person Responsible for Regulatory Compliance (PRRC), expanding digitalization rules, and introducing new pathways for breakthrough and orphan devices.

An Overview of the Commission’s Simplification Proposal

The proposal, formally designated COM(2025) 1023 final, amends the regulatory framework established by the MDR and IVDR; it does not repeal or replace either regulation. It introduces targeted amendments to specific articles to correct structural inefficiencies, improve market predictability, and reduce administrative costs for economic operators.

The proposal aims to ensure the smooth functioning of the internal market while maintaining the EU’s patient safety requirements. Medical device and IVD manufacturers, particularly micro, small, and medium-sized enterprises (SMEs), stand to benefit most from the administrative relief. Notified Bodies (NBs) will shift from repetitive paperwork toward continuous, risk-based oversight, and EU Authorized Representatives (EC-REPs) and Importers will also need to monitor these changes, as they will alter compliance verification expectations across the supply chain. The proposal covers the full device market, from low-risk Class I reusable surgical instruments and medical software to high-risk Class III active implantable devices and Class D companion diagnostics.

The proposal functions as a corrective measure within the broader regulatory framework. The MDR and IVDR were designed to set a global standard for device regulation, replacing the Medical Device Directives (MDD/AIMDD) and the In Vitro Diagnostic Directive (IVDD). The complexity of the new rules, however, puts the European market at a competitive disadvantage relative to jurisdictions like the US FDA. With this proposal, the Commission aims to keep the MDR and IVDR workable over time, so they support medical innovation rather than hinder it.

Eliminating the Five-Year Certificate Validity Limit

Under the current MDR and IVDR framework, CE certificates issued by NBs carry a maximum validity of five years. Once a certificate expires, manufacturers must undergo full recertification, even if the device has a clean safety record and no significant design changes. The Commission’s proposal removes this fixed five-year expiration date, and NBs will instead conduct periodic, risk-based reviews to confirm ongoing compliance.

For manufacturers, this is the most significant change in the proposal, both financially and operationally. It reduces the administrative burden and cost of full recertification cycles. Regulatory affairs teams currently spend substantial time compiling technical documentation solely to renew an existing certificate, diverting resources from product development. Under the continuous, risk-proportionate surveillance model, manufacturers retain market access as long as their post-market surveillance (PMS) data remains favorable and they pass regular surveillance audits. The change also eases capacity constraints on NBs, freeing auditor time for new or modified devices rather than legacy recertification.

Reducing the Scope of the Person Responsible for Regulatory Compliance (PRRC)

The MDR and IVDR introduced the mandatory role of the Person Responsible for Regulatory Compliance (PRRC) under Article 15. The current rules require specific educational degrees and professional qualifications for the role. Micro and small enterprises (SMEs) that outsource the PRRC role to an external consultant are also required to have that person “permanently and continuously” at their disposal; a vague standard that has caused contractual friction and operational confusion.

The proposal simplifies these requirements. It removes the detailed qualification prerequisites, giving manufacturers more flexibility to determine who has the appropriate regulatory expertise for their product lines. For SMEs, it also changes the availability requirement: an external PRRC must simply be “available” to the manufacturer, removing the expectation of permanent, continuous oversight.

Modernizing Clinical Evidence and Expanding the “Well-Established Technology” Definition

Demonstrating compliance with the General Safety and Performance Requirements (GSPRs) through clinical evidence under Article 61 is one of the most resource-intensive aspects of the MDR and IVDR. The current rules limit how manufacturers can use equivalence data and require extensive clinical investigations for many standard devices. The proposal codifies a “well-established technology device” concept directly into the regulations, defined as a device with a simple, common, and stable design, no associated safety issues, and a long history of safe use in the EU. It also broadens the definition of acceptable clinical evidence, allowing the safety and performance of certain devices to be demonstrated using non-clinical data, including in vitro, in chemico, and in silico testing, along with computational modeling.

For manufacturers, this creates a more predictable path to CE marking for legacy and low-risk devices. A product that qualifies as a well-established technology will face more proportionate clinical evaluation requirements. The legislative acceptance of in silico testing and computational modeling also lets manufacturers use simulation software to demonstrate device safety and structural integrity, rather than relying solely on clinical investigations or animal testing. This shortens development timelines and lowers the barrier to iterating on existing, clinically proven technologies.

See also: European Commission Expands Well-Established Technology Lists Under MDR

Accelerating Digitalization Through Electronic Instructions for Use (eIFU)

Current rules restrict IVD manufacturers’ use of electronic instructions for use (eIFUs), generally limiting them to professional-use devices that do not involve near-patient testing. The proposal supports digitalization of regulatory procedures by expanding eIFU use to professional-use IVDs intended for near-patient testing. It also clarifies that the EU Declaration of Conformity and the technical documentation file can be drawn up, maintained, and submitted to authorities in fully digital form.

For manufacturers, this reduces printing, packaging, and logistics costs. Moving to eIFUs for near-patient diagnostics also lets manufacturers update safety information and usage instructions through a secure, centralized web portal, which improves environmental sustainability. On the submission side, digital technical documentation standardizes conformity assessment procedures with NBs, supports automated data uploads to EUDAMED, and facilitates remote audits, which the proposal also encourages.

Reclassifying Software and Streamlining Post-Market Surveillance (PMS)

Rule 11 of the MDR’s classification criteria pushed most Medical Device Software (MDSW) into Class IIa or higher, regardless of actual patient risk, disrupting Europe’s digital health sector. The proposal adapts the classification rules through structural changes to Annex VIII, widening the possibility for certain software, reusable surgical instruments, and accessories to active implantable devices to be reclassified into lower risk tiers. It also simplifies Post-Market Surveillance (PMS) reporting: it reduces the required frequency of Periodic Safety Update Reports (PSURs) and extends the timeline for reporting serious incidents not involving immediate public health threats or death from 15 days to 30 days. It also reduces the scope of devices requiring a Summary of Safety and Clinical Performance (SSCP).

For manufacturers developing Software as a Medical Device (SaMD), this reclassification matters commercially. A downgrade to Class I allows self-certification, bypassing the Notified Body queue and speeding deployment of digital health tools to hospitals and patients. The extended vigilance reporting timeline gives quality assurance and clinical teams more time to conduct root-cause investigations of field incidents, rather than submitting incomplete preliminary reports to meet the previous 15-day deadline.

Creating Dedicated Pathways for Breakthrough and Orphan Devices

Unlike other major global markets, the EU has lacked dedicated, accelerated pathways for highly innovative technologies and devices intended for rare diseases. The proposal addresses this gap by introducing defined criteria and dedicated regulatory pathways for “breakthrough devices” (those offering a high degree of novelty and significant clinical impact for life-threatening or irreversibly debilitating conditions) and “orphan devices” (those treating rare diseases with small patient populations). These devices will be eligible for prioritized conformity assessments and rolling technical reviews by NBs.

For manufacturers, this restores the EU as an attractive launch market for new medical technology. Manufacturers developing novel cardiovascular implants, AI-driven diagnostics, or specialized pediatric surgical tools will no longer sit in the same certification queues as legacy devices. Rolling reviews let manufacturers submit technical documentation in sequential modules as clinical data becomes available, supporting ongoing dialogue with NBs and shortening time-to-market. For orphan device manufacturers, the pathway helps ensure that the low return on investment for small-population therapies is not consumed by disproportionate regulatory and auditing fees, which supports continued development of niche products.

How MedEnvoy Can Support 

The simplification of the MDR and IVDR is a welcome development for the EU regulatory landscape. Legislative proposals take time to navigate the European Parliament and Council, so manufacturers must maintain compliance with the current regulations while preparing their portfolios for the proposed changes. Navigating the transition between the current mandates and the future simplified framework requires regulatory expertise and a proactive compliance strategy. If your organization needs support navigating the EU medical device regulatory landscape, MedEnvoy can help.

Maintaining market access in Europe is critical to your global business objectives and to the health of the patients who rely on your technologies. MedEnvoy provides end-to-end support for device manufacturers navigating the complexities of the European market. Whether you need a qualified EU Authorized Representative for EU market access, EU Regulatory, or QMS Compliance Consulting Support, our team is available to help.

Do not let regulatory uncertainty delay your product innovation or disrupt your European market presence. We invite you to contact MedEnvoy today to discuss how our regulatory services can help keep your medical devices compliant, competitive, and accessible.