As of yesterday, the new EU regulation for in vitro diagnostic medical devices (IVDR 2017/746) became applicable.
The new set of requirements will completely change the regulatory framework thus affecting all of us working with IVDs, not at least when it comes to performance evaluation and clinical performance studies.
Did you for example know that the IVDR introduces new requirements for sponsors to apply for authorization or notify Competent Authorities for certain types of clinical performance studies?
Do not hesitate to contact us to learn more about how the regulation will affect your business.