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Europe names its first device assessments

Europe has named the first two medical devices selected for Joint Clinical Assessment under the EU HTA Regulation, with two further devices already in the pipeline.

22 September 2026

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Why we usually advise against an EU Joint Scientific Consultation for medical device and diagnostic companies

Understanding the relevant PICO across European markets, and the study design needed to satisfy it, matters more than ever. Yet we rarely recommend that a company apply for an EU Joint Scientific Consultation (JSC). Here is the thinking behind that.

26 September 2026

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Neurology & Pain

Chronic pain and neurological recovery are on Spain's 2026 assessment agenda.

29 September 2026

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Devices, Imaging & Surgery

From hybrid operating rooms to portable diagnostics, Spain is assessing the next wave of medical devices.

22 September 2026

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Rehabilitation, Telemedicine & Chronic Care

Care is moving into the home, and Spain's HTA system is assessing the tools that take it there.

15 September 2026

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Neonatal, Prenatal & Metabolic Screening

Early detection saves lives, and Spain's 2026 HTA agenda reflects it.

08 September 2026

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Infection & Antimicrobial Resistance

Spain is putting infection and antimicrobial resistance under the HTA microscope in 2026.

01 September 2026

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RedETS exists

Spain's 2026 health-tech assessment agenda is live, and 43 technologies are on it.

25 August 2026

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Case Study: When a Registry Becomes the SOLE Evidence Source

In 2025, NICE conducted a late-stage assessment of transcatheter aortic valve implantation (TAVI) devices. The decision? Rely ENTIRELY on UK registry data instead of international RCTs.

26 April 2026

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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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