Did Christmas come early to the EU? Proposal to simplify EUMDR

When it was released in 2017, the European Medical Device Regulation (EUMDR) promised high safety standards but instead created widespread regulatory friction. Even in 2018, when the medical device company I was working with first started working towards EUMDR compliance, our regulatory professionals predicted that the EU would no longer be the primary region to bring a medical device to market if this regulation didn’t change.

And 8 years after its publication, we’ve seen companies continue to resist EUMDR due to lengthy conformity assessments due to the lack of notified bodies and disproportionate costs to manufacturers. And, in some cases, companies have even withdrawn from the region entirely. 

Yesterday, however, the European Commission issued a proposed change to the regulation. These changes have not been finalized, but given that the medical device industry has been expecting a change to these regulations since March of 2025, it’s likely that what is being proposed is what will eventually become what some are calling EUMDR 2.0. 

The European Commission’s targeted revision (COM(2025) 1023 final) is a critical course correction. This is not a retreat from patient safety, but a strategic effort to streamline the bureaucracy that clogged the market, making the regulatory framework leaner, more predictable, and ready for global alignment.

For medical device leaders today, this moment is an opportunity for a reset: to stop trying to manage compliance chaos and implement a globally optimized Quality Management System (QMS).

BONUS RESOURCE: Click here to download your free GSPR template to help you ensure aherance to the general safety and performance requirements of EU MDR.

The two main goals of this proposal are to reduce red tape & reward innovation

The core motivation behind the EU's proposed amendments is easing the burden identified in recent evaluations. This streamlining targets the two most stressful compliance areas: continuous approval cycles and access for novel devices.

The document of proposed changes is 170 pages long, so it’s going to take some time for the industry and legislation to absorb. Some of the more far-reaching changes found in the proposal can be summarized as follows:

• Less Bureaucracy, More Stability: Instead of rigid 5-year certificate renewals, the plan aims to remove the maximum validity period for certificates. Notified Bodies will shift to regular, continuous surveillance based on the risk of the device, creating predictable stability for manufacturers and ensuring continuous quality maintenance.

• Adaptive Pathways for Novel Devices: The revisions introduce formal pathways for “breakthrough devices” and “orphan devices” (those for small patient populations). Devices meeting these criteria can undergo a priority and rolling review process, significantly accelerating market access for crucial innovations. Additionally, manufacturers can now leverage a wider range of data, including advanced in silico testing, promoting modern scientific methods over reliance purely on traditional clinical trials.

• Lighter Administrative Load: The proposal specifically cuts down on unnecessary paperwork. Requirements for the Periodic Safety Update Report (PSUR) and the Summary of Safety and (Clinical) Performance (SSCP) are reduced or streamlined, allowing manufacturers to focus resources on quality rather than duplicative documentation.

This is one step closer towards a global quality imperative

These proposed European changes arrive amid the shift in U.S. regulation, from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), which takes full effect on February 2, 2026.

The QMSR replaces the old QSR by incorporating the international standard ISO 13485:2016 as its foundation. This harmonization means that all medical device manufacturers globally must now operate on an ISO-based quality system to sell in both of the world’s largest markets.

The convergence of EU simplification efforts and U.S. harmonization demands a single, modern QMS strategy.

The solution to globally shifting regulations: a digital QMS blueprint.

The reality is, handling documentation using manual spreadsheets and scattered paper files will become increasingly difficult. We’re likely to continue seeing other regions adopt overlapping yet distinct requirements, such as the U.S. retaining of specific mandates for Medical Device Reporting and Unique Device Identification, that coexist on an ISO foundation.

Manufacturers will increasingly need to operate in a QMS that is truly digital, centralized, and integrated.

As the QMSR effective date draws closer, and as these proposed EUMDR changes become legislation, it’s important to look at your QMS and consider what some of the best-in-class medical device manufacturers have already done:

1. Eliminate Documentation Conflicts. The QMSR formally eliminates old terms like the Device Master Record (DMR) and Device History Record (DHR), consolidating documentation requirements into the Medical Device File (MDF), aligning with ISO. A centralized digital system is the only scalable way to manage this structural transition, ensuring all your specifications, design files, and manufacturing records are connected and instantly retrievable.

3. Integrate Risk and Data. The future of medtech expects enterprise-wide risk management, not just siloed risk assessments. A specialized digital QMS enables the automatic, closed-loop integration of design, production, and post-market data, turning data analysis into a proactive tool for continual improvement, a key focus of the QMSR.

4. Ensure Audit-Readiness. Both the EU proposals and the QMSR emphasize digitalization. Crucially, the QMSR removes previous exemptions, giving the FDA the right to inspect internal audit reports and management review minutes. This mandates a system that ensures these sensitive records are always factual, objective, and perfectly organized, providing peace of mind during any inspection.

BONUS RESOURCE: Click here to download your free GSPR template to help you ensure aherance to the general safety and performance requirements of EU MDR.

Can your QMS handle evolving regulatory requirements?

The revised MDR is paving the way for a more efficient Europe, while the FDA’s QMSR is forcing global alignment. There’s never been a better time to choose a QMS that is equally prepared to pivot toward this harmonized, efficient future.

At Greenlight Guru, we built our eQMS solution for medtech companies because we know that the ever-changing standards and regulations (like EU MDR) are a lot to handle for even the most seasoned medical device professionals. If you’re ready to experience the power of a purpose-built QMS, then get your free demo of Greenlight Guru today!