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ACL Registries and Registry-Based RCTs

The Scandinavian knee ligament registries have generated more than 70 publications across 70,000+ patients since 2004. This case study explores key findings, current limitations and the growing role of registry-based randomised controlled trials in orthopaedics.

26 April 2026

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Case Study: UK TAVI Registry and NICE HTG14

In NICE HTG14 (2025), the UK TAVI Registry became the primary evidence source for evaluating transcatheter heart valves. This case study explores how long-term registry infrastructure, device-level granularity and HES linkage supported registry-based HTA assessment in the NHS.

29 April 2026

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Case Study: What NICE HTG21 Reveals About Registry Limitations for Emerging Technologies

The National Joint Registry (NJR) is one of the largest orthopaedic registries internationally, yet NICE concluded that evidence for robot-assisted orthopaedic surgery remained insufficient for a definitive recommendation. This case study explores the implications for registry-based evidence generation and HTA strategy.

05 May 2026

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Germany: Implantable Loop Recorders in Syncope Diagnosis

Implantierbare Ereignisrekorder (ILR) ermöglichen eine deutlich höhere diagnostische Trefferquote bei ungeklärten Synkopen und gelten als leitlinienempfohlene Diagnostik. In Deutschland fehlt jedoch ein ambulanter Erstattungsweg, wodurch Patienten faktisch keinen Zugang zu dieser Versorgung erhalten.
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Implantable loop recorders (ILR) significantly improve diagnostic detection in patients with unexplained syncope and are recommended in clinical guidelines. Yet in Germany, the lack of an outpatient reimbursement pathway effectively prevents patient access to this diagnostic technology.

03 April 2026

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When the NUB Pathway Becomes a Distraction Instead of a Strategy

The German NUB pathway is frequently recommended in MedTech market access — but it is not structurally suitable for every technology. This article explains where NUB fits, where it does not, and why early strategic pathway assessment is critical for successful reimbursement in Germany.

15 May 2026

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Danish lab-data CKD example

How Denmark’s national lab databases reveal undiagnosed kidney disease and enable powerful RWE. Learn how CKD, AKI, and hyperkalemia can be tracked at scale—and what this means for MedTech innovators.

02 June 2025

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EU HTA for IVD's

With the new European HTA regulation coming into play for medical devices and diagnostics, one of the big questions is what impact these evaluations would have on market access for IVD products.

22 April 2025

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EU HTA for Medtech

With the new European HTA regulation for medical devices and diagnostics, one of the big questions is what impact these evaluations would have on market access for Medtech products.

14 April 2025

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Class IIb and III – Clarify Eligibility for 137 (h) prior to submitting NUB in Germany!

17 September 2023

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France: Temporary reimbursement pending results from clinical trial

France offers a pathway called PECT (The Prise en Charge Transitoire ) for temporary reimbursement off valuable and innovative medical devices and services pending completion of ongoing clinical trial.

18 July 2023

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Medical Device and EU HTA Regulation - Norwegian perspective

Norway has developed a national system with mini-HTA and national evaluations that include medical devices and diagnostics.

09 July 2023

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Coverage With Evidence Development for Digital Health

11 June 2023

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