IVDR Expert Session

Protect yourself as an IVD manufacturer or laboratory from costly mistakes and reputational damage at an early stage

For manufacturers of in-vitro diagnostic medical devices and laboratories with in-house IVD, 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 or a laboratory medical procedure must meet the IVDR'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 or laboratory procedure falls under the IVDR's requirements.  
   The company or laboratory 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 or laboratory medical procedure does not fall under the IVDR's requirements.  ​​​​​​​
   ​​​​​​​The company or laboratory 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.