What is IVDR Certification and Why is it Important for IVD Manufacturers
It's striking, yet true, that the global market size for in vitro diagnostics is projected to show a compound annual growth rate of 5.34% until 2030. Now, this massive growth comes with new rules. Medical device companies in Europe are now required to adhere to more stringent regulations. Among those changes is obtaining IVDR certification for their products. IVD remains the largest market in the global medical devices market, representing 13% of the total devices market as of 2024. But with growth comes responsibility. Companies must demonstrate that their products are safe and effective. This is where IVDR certification is critical. What Is IVDR Certification? IVDR is the short form of In Vitro Diagnostic Regulation. This rulebook from the European Union comprises rules for medical tests that doctors administer to determine if you have any illnesses. Consider blood tests, pregnancy tests, COVID-19 tests, or those genetic-testing kits. All of these require IVDR certification ...