TÜV Rheinland Updates Optical Test Standard for Medical Endoscopes

On May 16, 2026, German certification body TÜV Rheinland released version 3.2 of its Medical Endoscopes – Optical Performance Test Protocol, introducing a new mandatory test for motion blur suppression in 4K flexible video endoscopes seeking CE marking. This update directly impacts manufacturers, testing service providers, and regulatory affairs teams in the medical device sector—particularly those engaged in EU market access for high-resolution endoscopic imaging systems.

Event Overview

On May 16, 2026, TÜV Rheinland published Medical Endoscopes – Optical Performance Test Protocol V3.2. The revision adds a compulsory ‘Motion Blur Suppression (MBS)’ test requirement for all 4K flexible video endoscopes applying for CE certification. Under this test, devices must maintain an MTF50 decay rate of ≤12% while undergoing axial movement at 15 mm/s. Testing must be conducted using TÜV-designated dynamic targets and high-speed image acquisition systems. As a result, lead times for Chinese manufacturers submitting devices for evaluation have extended to six weeks.

Industries Affected by Segment

Endoscope Manufacturing Enterprises

Manufacturers of 4K flexible video endoscopes are directly affected because the MBS test is now a formal prerequisite for CE certification. Compliance requires hardware-level optimization—including lens design, image sensor readout speed, and real-time processing algorithms—to mitigate motion-induced resolution loss. Failure to meet the MTF50 decay threshold may delay or block CE marking.

Regulatory Affairs & Certification Service Providers

Third-party testing labs and regulatory consultants supporting CE submissions must now integrate the MBS test into their validation workflows. This includes acquiring or calibrating TÜV-specified dynamic targets and high-speed capture systems. Capacity constraints and longer turnaround times (now up to six weeks for Chinese applicants) may affect scheduling and resource planning.

Supply Chain & Component Suppliers

Suppliers of optical modules, CMOS image sensors, and embedded image-processing units face indirect but material impact. Components previously qualified for static resolution performance may no longer suffice; dynamic response characteristics—such as rolling shutter behavior, exposure time control, and frame-rate synchronization—now require verification earlier in the design phase.

What Enterprises and Practitioners Should Focus On Now

Monitor official implementation guidance from TÜV Rheinland

TÜV has not yet published detailed technical specifications for the dynamic target geometry or exact data acquisition parameters. Enterprises should track updates via TÜV’s official portal and certified training sessions to avoid misinterpretation during test preparation.

Prioritize MBS validation in early-stage R&D cycles

Given the six-week extended evaluation timeline, integrating MBS testing into prototype verification—not just final pre-submission checks—reduces late-stage rework risk. Engineering teams should assess sensor frame rates, exposure timing, and motion compensation firmware capabilities before formal submission.

Confirm alignment with notified body expectations ahead of submission

Some notified bodies may interpret the MBS requirement differently pending harmonization. Manufacturers should request written confirmation from their designated notified body on acceptable test setups and pass/fail evidence formats prior to initiating formal evaluation.

Review existing CE technical documentation for gaps

Legacy 4K endoscope files approved under earlier versions (e.g., V3.1) do not automatically satisfy the new MBS clause. Firms maintaining active CE certificates should assess whether post-certification changes or renewals will trigger re-evaluation under V3.2.

Editorial Perspective / Industry Observation

Observably, this update signals a shift toward performance validation under clinically relevant dynamic conditions—not just static resolution benchmarks. Analysis shows that TÜV Rheinland is aligning optical testing more closely with actual endoscopic use cases involving probe manipulation and tissue movement. While the MBS requirement is now codified in V3.2, its enforcement scope (e.g., retroactivity, exemptions for legacy models) remains subject to notified body discretion. From an industry perspective, this is currently best understood as a regulatory signal—indicating growing emphasis on motion-resilient imaging—rather than a fully matured compliance endpoint. Continued observation is warranted as other conformity assessment bodies and standards organizations (e.g., ISO/IEC) respond.

In summary, the introduction of the Motion Blur Suppression test reflects an evolving baseline for optical performance in advanced endoscopic devices targeting the EU market. It does not represent a broad-based revision of safety or biocompatibility requirements, but rather a targeted refinement in imaging fidelity validation. Currently, it is more appropriately understood as an operational adjustment for manufacturers and testers—requiring procedural updates and earlier engineering engagement—rather than a fundamental redesign mandate across the board.

Source: TÜV Rheinland official protocol release, Medical Endoscopes – Optical Performance Test Protocol V3.2, effective May 16, 2026. Note: Implementation details—including interpretation of MTF50 measurement methodology and applicability to hybrid rigid/flexible systems—remain under observation and are not yet publicly specified by TÜV Rheinland.