The proposed changes to MDR and IVDR amount to the most significant reform of the regulations since their adoption in 2017, when they replaced Europe’s long-standing Medical Device Directive (MDD).
Liz Renzaglia, Biovia Domain Lead for Medtech & Digital Health, says: “Over the past few years, the MDR and IVDR have placed undue strain on European innovators. These revisions aim to decrease administrative burden, compliance-related costs and legal uncertainties — improving Europe’s health innovation to the benefit of both enterprises and patients.”
The simplification is part of the EU’s strategy ‘Choose Europe for Life Sciences’ and its efforts to improve European competitiveness. With the proposed changes to the MDR and IVDR, the Commission aims to boost innovation and reduce certification-related costs for the industry by more than €3 billion per year.
The MDR and IVDR bottleneck
In the EU, medical devices are divided into four risk classes (I, IIA, IIB and III), depending on their intended purpose and inherent risks. The higher the risk class, the stricter the safety and performance requirements. Companies must be assessed by an independent ‘notified body’ before they can receive their CE marking and place their products on the European market.
There have been two core issues for innovators since the MDD was replaced by the MDR and IVDR, explains Renzaglia: “When the new regulations were implemented, there weren’t enough notified bodies to deal with the huge surge in applications, leading to a severe backlog in certifications,” she says. “But the main hurdles still affecting companies today are clinical evidence requirements and multiple products being up-classified under the MDR and IVDR, for example from Class I to Class IIA.”
These changes meant that companies had to re-certify existing products — even if they’d been on the market for years — but also that the re-certification process was subject to more stringent conditions in terms of technical documentation, clinical evidence and auditing.
“Certification should never be the reason your product doesn’t make it to market — or that your company fails.” – Liz Renzaglia
Among the worst affected were small and micro-sized companies, which make up around 90% of the industry and are usually least able to afford higher costs and long, uncertain timelines. “I’ve spoken with companies where their certification process went from six months to over three years,” says Renzaglia. “That delay has translated into serious strain, especially for start-ups trying to launch their first products.”
“Certification should never be the reason your product doesn’t make it to market — or that your company fails,” she adds.
Forcing Innovators to Seek Out Foreign Shores
By making it harder to bring products to market, the MDR and IVDR have inadvertently decreased the competitiveness of the European medtech sector. “Product safety is of course essential,” says Renzaglia. “But when the certification process becomes too complex or costly, companies are forced to look beyond Europe for their initial market entries.”
This has an economic impact, but it also carries negative implications for European patients, who lose access to cutting-edge health innovations — even when those products were initially developed in the EU.
“When the certification process becomes too complex or costly, companies are forced to look beyond Europe for their initial market entries.” – Liz Renzaglia
“People often compare the MDR and IVDR with other international regulations, particularly the FDA in the US. With the initial launch of the MDR and IVDR, Europe failed to adopt best practices that already exist elsewhere — such as fast-track pathways for solutions to critical unmet needs or orphan indications — to the detriment of European innovators and patients.”
The Proposed Revisions: Simplification, Recalibration and Modernization
Key changes in the proposed revisions announced in December 2025 include:
- Abolishing the 5-year certificate cap, instead moving to risk-based periodic reviews.
- Recalibrating some classifications, so certain products (including software) fall into lower risk classes.
- Reducing notified body involvement for some lower/medium-risk devices and IVDs.
- Broadening what qualifies as clinical data, to modernize evidence-generation, including through in silico methods and New Approach Methodologies (NAMs).
- Allowing more flexibility for in-house tests and devices used by health institutions, including IVDR changes.
- Greater digitalization of declarations, technical documents, and processes, as well as introducing innovation tools, like regulatory sandboxes for emerging technologies.
The changes are framed as “targeted simplification”: cutting duplication, improving predictability, and modernizing framework, while maintaining the protection of public health.
“These revisions aim to simplify existing rules and make them easier to navigate,” Renzaglia explains. “For innovators, predictability is everything — it’s what lets you plan, fundraise, and grow your company.” She adds that reducing the regulatory burden could “free up time and resources to focus on what matters most: proving safety and performance to get better solutions to patients faster.”
Still Missing: Clarity for Software Solutions
“The reaction from our members has been cautiously optimistic,” Renzaglia shares, referring to Biovia members in the medtech and digital health space. “Companies are pleased that the Commission reviewed the regulations sooner than expected, and that their pain points are being acknowledged and addressed.” But there is also fear that these proposed revisions will be watered down in the coming year.
There’s also still a notable gap remaining for the digital community: a lack of clarity on the rules for Software as a Medical Device (SaMD). Under the MDR, software products have often been up-classified into higher-risk categories, with stricter requirements for clinical evidence, auditing, and change management — particularly challenging for companies with AI systems that evolve over time.
“Innovators have been left grappling with the question of how to certify an AI-based solution, when the algorithm is constantly updating.” – Liz Renzaglia
“Innovators have been left grappling with the question of how to certify an AI-based solution, when the algorithm is constantly updating,” says Renzaglia. “Their dynamism is what makes these products interesting but also makes them hard to certify under the current rules.” Given the lack of clarity, some software companies have chosen to delay certification or even downgrade the functionality of their products to avoid medical device classification altogether — “making it easier to enter the market but reducing the potential impact for patients and clinicians.”
Next Steps for Biovia and its Members
Biovia’s focus now is twofold: keeping members informed and helping them to navigate the shifting regulatory landscape, as these changes are made concrete.
The cluster will be watching as the Parliament and Council discuss the Commission’s proposal and potentially suggest amendments. The revisions to the MDR and IVDR will be applied six months after they’ve been published in the EU’s Official Journal, with a staggered timeline for certain measures spanning several years. “We’ll provide our members with updates, and keep a finger on the pulse of progress,” says Renzaglia.
Find out more about Biovia’s trainings and member benefits!
Biovia will also continue to expand its hands-on regulatory support for members. This has included NoBoCap — an EU-funded initiative to increase the capacity of notified bodies and improve the quality of certification applications through trainings, digital tools, and practical guidance for companies.
The NoBoCap project is scheduled to conclude in 2026, but Biovia is supporting efforts to spin the community out into a non-profit organization, and to keep providing resources and trainings on how to submit successful dossiers — “particularly for micro and small enterprises, which often lack in-house regulatory capacity,” says Renzaglia.
A Europe-First Launchpad for Medtech Innovation
For Biovia, the end goal is straightforward: a regulatory system that protects patients, without creating a barrier that diverts innovators away from Europe.
Read this article for more on the topic of anchoring innovation in Europe!
“Our members are developing fantastic health innovations,” Renzaglia says. “As an American living in Europe, I’ve been happy to use my experience to help European companies enter the US market. But it’s a shame when these products reach patients on the other side of the ocean before they reach patients next door.
“My biggest hope is that these MDR and IVDR revisions improve predictability and reduce resource intensity, so that more companies can confidently make Belgium their beachhead, and Europe their primary market.”
