EU CE Endoscope Certification Data Analysis 2022-2026

By reviewing public endoscope-related device records in EUDAMED and related public search tools, we analyzed how EU CE endoscope activity evolved from 2022 to 2026. The overall picture is clear: public CE activity accelerated sharply in 2025 and 2026, with especially strong momentum in single-use products for urology, pulmonology, and gynecology, while reusable endoscopes remained firmly established in general surgery, ENT, and many rigid-scope applications.

One point must be made at the outset. In the EU system, a notified body certificate is not always transparently mapped one-to-one to every individual endoscope model in the public view. As a result, the most reliable public market-observation metric is not the absolute number of all CE certificates issued, but the number of **publicly traceable CE endoscope samples** visible in the open dataset. This is the approach used in this article.

Within the core sample pool used for this analysis, we identified 1,498 publicly traceable EU CE endoscope samples between 2022 and 2026. Of these, 253 records did not expose a clear first-public year in the accessible version metadata, so they were excluded from the year-by-year trend summary below.

Among the records that could be dated, the annual pattern was as follows:

2022: 26

2023: 116

2024: 84

2025: 478

2026: 541

The message is straightforward: public EU CE endoscope visibility has moved from scattered activity to a much more active, scaled-up pattern. The strongest acceleration appeared in 2025 and 2026, reflecting broader MDR-era public disclosure, more aggressive European market entry, and rising participation from Chinese, Japanese, Korean, and European manufacturers.

The European endoscope market is not moving toward single-use products in a uniform way. Instead, the market is fragmenting by specialty and use case.

The main patterns are clear.

Urology shows the strongest single-use momentum, especially in ureteroscopes.

Pulmonology is one of the clearest single-use growth segments, particularly in bronchoscopy.

Gynecology is increasingly active in single-use hysteroscopy.

Gastroenterology still retains a strong reusable base, although single-use products are clearly entering the field.

General surgery remains more reusable-oriented overall.

ENT is still dominated by reusable rigid-scope systems.

Orthopedics appears more balanced, with both single-use and reusable products active.

After removing obvious accessories, imaging systems, light sources, brushes, sheaths, and other non-core scope records, the public sample activity by specialty was approximately as follows:

Gastroenterology remains anchored by reusable systems. Traditional video gastroscopes and colonoscopes still hold a strong place in the public EU record. At the same time, single-use gastroscopes are no longer rare. For new entrants, the challenge is not simply obtaining CE marking, but defining whether the product wins on infection control, workflow efficiency, or image performance.

Bronchoscopy is one of the clearest single-use growth tracks in Europe. Public records show repeated appearances of single-use flexible video bronchoscopes and related models. ICU, anesthesia, emergency, and bedside use cases continue to support this trend, making pulmonology one of the most commercially validated single-use endoscope categories.

Urology, especially ureteroscopy, is one of the strongest single-use segments in the EU market. Terms such as “Single-Use Ureteroscope,” “Disposable Flexible Ureteroscope,” and “Digital Flexible Ureteroscope” appear frequently in public records. In practical market terms, urology is one of the most mature pathways for single-use endoscope expansion in Europe.

General surgery shows high public activity, especially in laparoscopes and choledochoscopes, but the overall profile is still more reusable than disposable. Image quality, durability, and integration into surgical workflows continue to favor reusable systems in many applications. Even so, early single-use activity is visible and likely to expand in selected use cases.

Gynecology is an increasingly important growth niche for single-use endoscopy. Disposable hysteroscope products appear regularly in the public sample set, suggesting that office-based procedures, simplified workflow, and infection-control concerns are helping drive adoption. This department is likely to remain one of the more dynamic EU growth areas.

Arthroscopy still has a substantial reusable installed base, but single-use video arthroscopes now have visible public presence as well. Compared with pulmonology or urology, orthopedics is not a one-direction market. It looks more like a dual-track segment in which conventional reusable systems remain stable while disposable solutions expand selectively.

ENT remains heavily reusable in the public dataset, particularly in sinuscopes and related rigid-scope applications. The category is less about rapid disposable conversion and more about standard-product iteration, optics upgrades, and line expansion. For manufacturers, this makes ENT a more traditional but still active CE pathway.

The broad pattern is as follows.

Pulmonology, urology, and gynecology are the strongest single-use growth zones.

Gastroenterology remains reusable-led, but single-use products are gaining visible traction.

General surgery and ENT are still primarily reusable.

Orthopedics is increasingly a mixed landscape.

For manufacturers, the strategic question is no longer just whether a product can obtain CE marking. The more important question is which department it targets, whether it fits a single-use or reusable workflow, and which clinical pain point it solves most clearly. That is what will determine whether certification turns into real commercial opportunity.

Sources

EUDAMED overview:

Notified Bodies and Certificates module:

EUDAMED Public API User Guide:

Public search interface: