In September 2017 the Belgian Competent Authorities of In Vitro Diagnostics merged with the Medical Devices authorities.
Based on experience and cooperation after the merger, Competent Authorities are more efficient and better organized than before.
Obelis is positive about the improvement of the functionality of the CA which will directly influence the assessment of the documentation submitted for many procedures. Applications for Free Trade Certificates or Notifications will be assessed more quickly, but most importantly, we strongly believe that the merger increases efficiency which will guarantee a safer EU market.
What are the advantages of the CA merger?
· Easier traceability of Notification and FTC applications for both IVD and MD
· Increased surveillance
· The medical devices and in vitro diagnostics data will be stored together
· Reduction of errors and malfunctions of the devices entering the EU market, which directly improves patient safety
If you wish to know more about the changes brought by recent merger or by the new MDR & IVDR, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any questions you may have and will be happy to assist you in safeguarding your products’ compliance.