The BioMed Alliance, of which ERA is a member, is raising awareness of the possible consequences of a poor IVDR implementation. The date of application of the new EU Regulation for In Vitro Diagnostic Medical Devices (IVDR) is only one year away, and the BioMed Alliance healthcare diagnostic providers are seriously concerned about the status of implementation of the IVDR. To date, many critical regulatory elements are not in place and important guidance is still lacking, making it extremely difficult for the EU diagnostic sector to be fully prepared in time for May 2022 and thereby threatening to affect patients’ lives across Europe.
The enclosed statement entitled: “Implementation of the new EU Regulation for In Vitro Diagnostic Medical Devices: a ticking bomb for the diagnostic sector” clarifies the hard stop that the diagnostic sector will face for conventional CE-IVDs if we do not collectively stand up now. In addition, clear and appropriate guidance is needed for in-house devices, also known as laboratory developed tests (LDTs), in order to help laboratories to prepare in time for the new legislation and to support the development of innovative solutions for niche applications, rare diseases and rapid responses to health crises.
The diagnostic sector will be transformed by the new regulation and it is our responsibility to ensure a proper implementation of the IVDR.