Core value dossiers for medical technologies
Essential tool to support market access and marketing efforts through the lifecycle of the product
White Paper: Market access for medical devices in Europe: England, France, Germany, Italy and Spain
Get insights from MTRC White Papers to advance your understanding of European market access for medical devices
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Publication Digest: Early and accelerated access programs for medical devices in the European Union: mapping regulatory derogations and national schemes
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest.
In a recent publication, Haon et al. mapped early and accelerated access pathways for medical devices across the 27 EU Member States to clarify how patients may receive devices before full routine market access in situations of unmet need.
The authors found that early access in Europe relies on EU regulatory derogations, particularly Article 59 of the EU Medical Device Regulation, enabling national authorization of non-CE-marked devices in exceptional circumstances. Nationally, at least half of Member States operate compassionate or expanded access schemes, with some complementing these through reimbursement or evidence-development mechanisms. The study highlights a fragmented and unevenly documented European landscape, calling for more transparent, integrated, and equity-oriented access models.
Access the full-text article here.