EU MDR’s 2026 Milestone: First Extended Deadline & Compliance Checkpoints

European medical device makers face a key May 26, 2026 deadline under the extended MDR transition timelines. The MDR extension granted by Regulation (EU) 2023/607 includes the first cutoff date when Class III custom-made implantable devices must meet MDR requirements. This milestone marks a turning point for manufacturers that have been

relying on legacy certificates under the old Medical Device Directive (MDD).

Companies should understand that by this date, any device that fails to meet the MDR

requirements or obtain a new CE certificate could be pulled from the market. The 2026

deadline represents the first in a series of phased compliance checkpoints, with Class II and

lower-risk devices facing deadlines in 2027 and 2028.

This transition period is designed to prevent supply shortages, but it does not extend the

time companies have to prepare their technical documentation. By 2025, manufacturers

should already have secured agreements with Notified Bodies and finalized their technical

files to avoid delays. Those that wait too long risk losing their EU market access due to

bottlenecks in the conformity assessment process.

The message is clear: 2026 is the “last call” for high-risk devices. Companies that act early

will not only meet compliance deadlines but also gain a competitive advantage as MDR

readiness becomes a differentiator in the European market.

If your organization needs help preparing for the 2026 MDR deadlines or aligning

documentation with EU requirements, PRP Compliance’s experts can help ensure a smooth

transition.