The measurable cost of regulatory uncertainty
More than 40% of medical device companies face regulatory costs exceeding €500,000, and nearly half of these costs are avoidable.
Manon Marault
More than 40% of medical device companies face regulatory costs exceeding €500,000, and nearly half of these costs are avoidable.
I have observed that a significant share of regulatory compliance spending in the Medical Devices (MD) sector could be avoided. For 𝗺𝗼𝗿𝗲 𝘁𝗵𝗮𝗻 𝟰𝟬% 𝗼𝗳 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀, these regulatory costs are estimated at 𝗺𝗼𝗿𝗲 𝘁𝗵𝗮𝗻 €𝟱𝟬𝟬,𝟬𝟬𝟬. And nearly 50% of these costs are actually linked to what I identify as regulatory uncertainty, often due to the absence of a clearly defined roadmap.
Focus on regulatory uncertainty 🧭
• Avoidable costs: Strategic planning and a deep understanding of regulatory requirements could significantly reduce these costs.
• Importance of the roadmap: Without a well-established regulatory pathway, companies can find themselves navigating blindly, increasing the risk of costly mistakes. These mistakes often include incorrect MD classification, lack of awareness of regulatory deadlines, and delays linked to Notified Body (NB) approval timelines, which can extend beyond initial forecasts despite good preparation.
• Impact on market launch: Delays in market launch can occur, directly affecting competitiveness and revenue generation.
Given these stakes, drawing up a precise and structured regulatory roadmap becomes imperative, not only to remain compliant but also to optimise operational efficiency and minimise unnecessary expenses.
More than 40% of companies face regulatory costs above €500,000.
Nearly 50% of costs are due to avoidable mistakes.
A clear roadmap reduces risks and unnecessary expenses.
