A CE mark lets you place a device on the Greek market. It does not get anyone to pay for it. Reimbursement in Greece runs through two separate channels — the EOPYY benefits catalogue for products dispensed to patients in the community, and centralised public tendering for products consumed inside hospitals — and each has its own listing logic, its own price ceiling and its own timetable. Manufacturers who plan only for conformity assessment routinely discover the access work has not started.
Two channels, two different questions
The first question is which channel your device sits in.
- The EOPYY channel. EOPYY, the national health services provider, covers the overwhelming majority of the insured population. It reimburses medical devices and supplies only where they appear in the Unified Regulation of Health Benefits — the EKPY. If a category is not in the EKPY, there is no prescription pathway and no reimbursement, however strong the clinical evidence.
- The hospital channel. Devices consumed in public hospitals are bought, not reimbursed. Access here means winning a place in a tender run centrally by EKAPY, the National Central Health Procurement Authority, or in a hospital-level procedure where EKAPY has not yet concluded a national contract.
Some portfolios straddle both. The commercial model, the evidence package and the pricing strategy differ enough that treating them as one market is a common and expensive mistake.
How the reimbursed price is set
For products in the EKPY, the reimbursement ceiling is not negotiated product by product. Article 108 of Law 4461/2017, as amended by Law 4472/2017, sets the maximum price reimbursed by EOPYY by reference to the average of the three lowest prices across EU Member States. The practical consequences are familiar to anyone who has managed a European price corridor:
- Your Greek ceiling is largely determined by list prices you set elsewhere in Europe, often years earlier.
- Launch sequencing matters. A low early price in a small market can travel.
- Where the manufacturer’s price exceeds the EKPY ceiling, the difference is generally borne by the patient — which shapes uptake far more than the listing itself.
The hospital channel is a procurement problem
Centralised purchasing through EKAPY has consolidated buying power and introduced reference price ceilings drawn from observed tender prices. For suppliers this changes the work: technical specifications, product coding, documentary compliance and the ability to hold a price for the contract duration decide outcomes more often than clinical differentiation does. Delays in national tender procedures also remain a reality, and companies need a plan for the interim procedures hospitals use to keep supply flowing.
The EU layer is now arriving
Device manufacturers should also be preparing for the EU Health Technology Assessment Regulation. Commission Implementing Regulation (EU) 2025/2086, adopted on 17 October 2025 and in force from 9 November 2025, completed the procedural framework for joint clinical assessments of medical devices and IVDs. Scope is limited to higher-risk products — class IIb and III devices and class D IVDs — and selection is made from an annual list rather than applying automatically. Joint scientific consultation windows for device developers have already opened. A joint clinical assessment does not decide Greek reimbursement, but it will increasingly supply the clinical dossier that national bodies work from, so the evidence you generate for it should be planned alongside your MDR clinical evaluation, not after it.
How PQRA helps
PQRA supports device manufacturers across both channels: assessing whether a product fits an existing EKPY category or needs one, building the pricing and reference-price analysis behind a Greek launch, preparing tender documentation for EKAPY procedures, and aligning MDR clinical evidence with what HTA bodies will ask for. Our regulatory and market access teams work from the same file, so the conformity assessment strategy and the access strategy do not pull in opposite directions.
Planning a device launch in Greece, or reviewing why an existing one is not converting into volume? Get in touch with PQRA to discuss your portfolio.
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