MedCon: Don’t change course based on proposed MDR/IVDR reforms

COLUMBUS, OH – Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline, but a speaker at a recent meeting told attendees not to change their priorities based on proposed legislation.

Fabien Roy, a medical device and pharmaceutical lawyer and partner at Arnold & Porter, said that targeted MDR amendments were proposed in mid-December 2025 in response to constraints on notified body capacity, the rising cost of compliance, persistent supply disruptions, and a slowdown of innovation and regulatory uncertainty in the European Union (EU). (RELATED: EU officials detail proposed MDR, IVDR revisions, Regulatory Focus 27 January 2026)

Roy also acknowledged the political pressure to accelerate the timeline for the proposed reforms (RELATED: EU officials optimistic about proposed MDR/IVDR reforms, Regulatory Focus 23 March 2026).

However, he noted that the proposal is still in its early stages. “What we are discussing today is a proposal, and a proposal is not a law. You need to keep with your objective to comply with the MDR,” he told attendees at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

There are several key changes to the MDR in the proposed legislation, including giving legacy devices an extended validity period and keeping the validity of legacy device certifications after the transition period if they are designated as an orphan device through an expert panel.

Another major area of change is with artificial intelligence (AI)-enabled medical devices. Currently, manufacturers in Europe are subject to both MDR and EU AI Act requirements for their medical devices. Roy noted that there is currently discussion to let MDR serve as the center for AI-enabled medical devices. The change would mean “AI requirements will be set directly in the MDR by some Commission-delegated acts or implementing act by the European Commission,” he explained.

However, the proposed legislation will not be in place before the AI Act is enforced, Roy said. One solution being discussed between the European Parliament, Council of the EU, and the European Commission is to delay implementation of AI Act for medical-device software.

“[I]t’s going to take a while before it’s adopted and in legislation, and we need urgency, a solution, because we don't have the time,” Roy said. “Basically, by the summer of 2026, in a couple of months, the AI Act will be applicable.”

Rule 11 may also change under the proposed legislation to initially classify software medical devices as a class I device by default unless it meets several exceptions that would place the device in a higher classification. Roy said since the vast majority of medical device software currently on the market is class IIa or above, stakeholders need more information on why this change is being made, as it is not immediately clear based on the legislation whether class I will be the default for this device type moving forward.

“This will be one of the most discussed provisions or revisions between the Parliament and the Council, because there is no clarity on what is going to change with that revision,” he explained.

Concerning notified bodies, some changes being proposed include a more formal pre- and post-submission framework with manufacturers, the notified body authority serving as an ombudsman during disputes being notified bodies and manufacturers, and fee reductions and payment deferrals for smaller businesses and conformity assessments for orphan devices.

There are also changes being proposed for breakthrough and orphan devices, with formal designation criteria being planned for both device types that includes priority review and rolling review, certification with limited pre-marketing data, and early scientific advice.

Roy said he doesn’t see these changes being implemented until at least the middle of next year, and a transition period that would last until the end of 2027. In the meantime, companies need to be focusing on the timeline for complying with the MDR during the transitional provision period, including the first EUDAMED modules.

“It's very urgent if you are not yet compliant to get a cell number and to register, because without that, you will be out of compliance,” he said.

“Keep an eye on the proposal, keep an eye on the development, but do not change the trajectory based on what we could see in the proposal today,” Roy added.

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