Implementation of IVDR (In Vitro Diagnostic Regulation) scheduled for 2022
Since project start, DiaSys has kept its customers up to date with regard to the implementation steps and requirements. It is becoming apparent that the continued incomplete provision of the necessary infrastructure from the authorities as well as the immense bottleneck with the necessary “Notified Bodies” (Supervising authorities) will lead to problems in implementing the IVDR for the majority of all manufacturers.
For this reason, DiaSys has recently submitted a written petition to twelve local politicians to support a postponement of the effective date (May 2022) of the IVDR by at least one year. As the timely and stringent implementation of the remaining infrastructure is predictably at risk, an urgent need for action has emerged to prevent real bottlenecks in diagnostic testing in order to protect patients, public health and the continuity of health care. As part of their general approach to companies and employers in their own constituency, the two state MPs Jörg Denninghoff and Dr. Tanja Machalet paid a visit to the company DiaSys in May 2021. During a two-hour meeting, DiaSys not only introduced the company's business field, but also their concern regarding a moratorium on the IVDR. Mr. Denninghoff and Dr. Machalet are very interested in the topic and understand the resulting precarious situation for DiaSys as an IVD manufacturer. They left with the promise to pass on the matter to the relevant bodies.
IVDR moratorium follow-up meeting
Because of the above-mentioned note to politicians, the deputy chairman of CDU/CSU (German political party) in the European Parliament, Ralf Seekatz, Member of the European Parliament, has reacted. On 18 May 2021, a virtual meeting took place with him, Dr. Jan Gorka and Stefanie Giesener from DiaSys; both presented the precarious situation of the industry. Mr Seekatz encouraged DiaSys in its request for a moratorium and has named contact persons to extend the dialogue with politics on a national level.
On the same day, DiaSys approached the State Secretary Dr. Thomas Gebhart (Member of the German Bundestag) and Erwin Rüddel (Member of Bundestag and Chairman of the Health Committee of the Bundestag) - with the successful outcome, that the issue was directly forwarded the Federal Ministry of Health (BGM).
At the same time, the VDGH (Verband der Diagnostika Industrie e.V.) has reported that the topic will be part of the agenda of the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) meeting on 14-15 June. After the VDGH, too, had made use of their political contacts to bring the issue to the attention of the European Parliament from the national side, it now seems that things might finally be moving. The EU Council for Employment, Social Policy, Health and Consumer Affairs meets in the EPSCO Meeting. Now it will be necessary to wait and see what will be decided and which additional measures might be taken.
Stefanie Giesener Head of Quality Management & Regulatory Affairs