MDR/IVDR Approval

The EU approval of medical and IVD medical devices has become difficult and lengthy

• ​​​​​Unmanageable Amount of Regulatory Requirements
  ​​​​​​​The requirements of the MDR and IVDR have increased significantly compared to the former EU directives. In addition, the vast number of standards and MDCG documents (and sometimes their lack of quality and coordination) make it difficult to gain an overview and under­stan­ding of product-specific implementation.
   
• Lengthy and Costly Conformity Assess­ment Procedures
  ​​​​​​​Many manufacturers find it difficult to create compliant docu­men­ta­tion. In addi­tion, many notified bodies do not have sufficient capacity. Both of these factors slow down the conformity assessment process, sometimes for years. During this time, manufacturers do not generate any revenue while the costs for approval continue or even increase.
   
• Lack of Appreciation and Meaning­ful­ness of the Tasks
  ​​​​​​​Regulatory affairs teams are often per­ceived as obstructionists or "document staging areas," even though they do every­thing they can to provide all reviewers and auditors with the required documents. At the same time, the teams are aware that the documentation often helps neither the company nor the patients.
   
• Uncertainty and Stress
  ​​​​​​​Many feel insecure before audits and during inspections of the technical docu­men­tation by authorities and notified bodies. This is because incorrect classi­fi­cation, deviations, and rework can mess up the entire schedule.