MDR Expert Session

Protect yourself as a manu­fac­turer of medical devices from costly mistakes and reputational damage at an early stage

For medical device manufacturers, the regu­la­tory landscape has become confusing, which unfortunately can regularly lead to serious mistakes: 
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1. It is realized too late that the device must meet the MDR's requirements.
   Necessary resources and activities are not planned, which throws budgets and sche­dules out of kilter. In the worst-case scena­rio, customer deadlines cannot be met, or the business case will no longer be profi­table. 
    
2. It is mistakenly assumed that the device falls under the MDR's requirements.
   The company goes to unnecessary expense or even decides against developing or mar­keting its device or procedure, thereby missing out on opportunities. 
    
3. It is mistakenly assumed that the device does not fall under ​​​​the MDR's require­ments.
   ​​​​​​​The company exposes itself to risks under civil and criminal law. There is a high pro­ba­bility of warning letters from competitors. The potential financial and reputational damage is significant.