The cost of certifying a single medical device under the MDR can range between €200,000 and €600,000. This includes compliance with all regulatory requirements, from clinical evaluation and risk assessment to obtaining notified body approval. An EU survey of 501 companies provided additional context: 1. 242 manufacturers aim to comply with the MDR for their entire product portfolio, but others are choosing to reduce or rationalize their product lines. 2. 159 companies believe that bringing their full product range into compliance is neither financially sustainable nor profitable. 3. Some companies face delays in certification (70 companies) or report a lack of clinical evidence (60 companies) needed to meet MDR requirements. _A recent report by the French medical technology association SNITEM_