Notified body capacity improves, but class III queues persist

The designation of additional notified bodies has eased the worst of the MDR bottleneck. Average time from application to certificate now sits at eleven to fourteen months for class IIa devices, down from the eighteen-month peaks recorded in 2023. Industry associations attribute most of the improvement to better scoping at the front end of the application, where manufacturers hold a structured dialogue with the assessor before the file is submitted, and to reviewers becoming familiar with the technical documentation format introduced in 2021.

The picture is less even at the top of the risk scale. Class III applications, and devices that combine a medicinal substance or an IVD companion diagnostic, still wait considerably longer, with some files in assessment for more than two years. Notified bodies report that these applications require specialist assessors who are in short supply, and that gaps in clinical evidence remain the single most common reason for a clock stop during review.

Small and medium-sized manufacturers remain the most exposed to those delays. A single failed submission can consume most of a company's annual regulatory budget, and the cost of a second assessment round is rarely recoverable from customers. Several national trade bodies have asked for a formal pre-submission dialogue, arguing that structured early feedback is considerably cheaper than a rejected file and a delayed launch.

The practical advice from consultants is unchanged: treat the technical documentation as a living dossier rather than a submission artefact. Manufacturers that maintain a gap analysis against Annex I, update their clinical evaluation with post-market data, and keep the risk file aligned with complaint trends report shorter assessment cycles, largely because they spend less time answering questions raised late in the process.