Romanian medical equipment market at the end of 2025: under pressure from MDR
MDR also creates an opportunity: the market is cleansed of questionable products and occasional suppliers. For hospitals, this means, over time, a safer and more predictable portfolio of equipment.
By the end of 2025, the main force shaping the Romanian medical device market is no longer just financing – but compliance with the European Medical Device Regulation (MDR). For a market dominated by imports and local distributors, the MDR has become the factor that decides which products can still be sold, how much they cost and who survives in the medium term.
The MDR brings much stricter requirements on safety, traceability and post-market surveillance. Manufacturers must demonstrate, through solid clinical data, that their devices are effective and safe, and this translates into much higher certification costs. For importers and distributors in Romania, this means complex documentation, regular audits, clear vigilance processes and continued pressure to work only with manufacturers fully aligned with the new rules.
The consequences are already visible: some older devices are disappearing from the market because they are no longer worth the cost of re-certification, certain low-cost product lines are being withdrawn, and hospitals are having to adapt their specifications and purchasing practices. The difference between a paper supplier and one with a real service infrastructure, risk management and technical support is becoming much clearer in tenders.
For small Romanian companies, the MDR is a very high barrier to entry: it is no longer enough to import a product with an old CE and a simple technical sheet. It requires regulatory specialists, internal procedures, traceability systems and close collaboration with manufacturers. Many will be forced to abandon certain ranges or partner with larger players.
On the other hand, the MDR also creates an opportunity: the market is being cleansed of questionable products and occasional suppliers. For hospitals, this means, over time, a safer and more predictable portfolio of equipment. For serious distributors, who invest in compliance, service and consulting, 2025 marks the beginning of a period in which quality and professionalism become real competitive advantages, not just words in brochures.