IVDR Implementation - A short state of affairs

DiaSys follows their internal project plan in order to comply with the new regulations. We will be ready to submit files to maintain the supply of products to healthcare operators. 

During implementation we also have to observe occurrences on regulatory level to adjust the internal project plan in an early stage if necessary. At the moment we have some concerns that all essential elements of the new regulatory system will be in place at the right time:

· Notified bodies: all bodies need to be re-designated or designated to be authorized to assess, certified or re-certified medical products for compliance with the new regulations;

· Implementing acts: 18 in total, only two have been published so far;

· Expert panels, reference laboratories, and common specifications: these are essential to new CE marks and high-risk devices, and not yet in place;

· Standards and guidelines: needed for industry and other players to have a common interpretation of correctly applying the new regulations.

DiaSys is well organised in the German Manufacturer Association (VDGH e.V.) as well in the European Association (MedTech Europe). A lot of colleagues are engaged in different boards and working groups and invest heavily to comply with the new IVDR, but we also depend on a proper implementation of the essential elements by regulatory officials.

Due to the situation explained above we cannot provide you with more details today. An update will be given in one of the next dialog issues. In case of further questions please do not hesitate to contact me directly.