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Reimbursement strategy

Market Access Strategy for Medical Devices in Europe

Strategic recommendations on the topic of market access pathways for medical devices and IVD tests

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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The 2026 Work Programme for the joint EU-level HTA framework released

On November 28, 2025, the Member State Coordination Group on Health Technology Assessment (HTACG) published its annual Work Programme for 2026, outlining the priorities and activities of the HTACG and its subgroups within the joint EU-level HTA framework (EU HTAR). The framework became fully operational on January 12, 2025.

In 2026, the first joint clinical assessments (JCAs) for medical devices are planned to be initiated. The HTACG may launch approximately five JCAs covering a selection of medical devices, which may also include in-vitro diagnostics. The first assessments are expected to start in June 2026.

For medicinal products, 12 JCAs are currently under development, and an additional 50 are anticipated to begin in 2026.

The HTACG will continue to offer Joint Scientific Consultations (JSCs) to developers of medicines and medical devices. In 2026, the HTACG plans to initiate between two and five JSCs for medical devices. Through its JSC Subgroup, the HTACG will work towards gradually increasing the number of consultations in subsequent years.

Requests for JSCs may only be submitted during the application periods specified in the HTACG Annual Work Programme. In 2026, the submission periods are as follows:

  • 7 January to 4 February 2026
  • 1 to 29 April 2026
  • 3 June to 1 July 2026
  • 23 September to 21 October 2026

Requests for JSCs must be submitted via the secure HTA IT platform using the dedicated JSC request templates. Following approval of a JSC request, applicants are required to submit a briefing document, which constitutes a more detailed dossier. 

See the full details in English here and here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.

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