A recent representative survey by the VDGH emphasizes the urgency of extending the deadline. "Our industry has worked intensively on the implementation of the IVDR. However, despite this commitment, the complex bureaucratic requirements of the regulation still represent a significant barrier to implementation," explains Dr. Martin Walger, Managing Director of the VDGH. "More than a third of all class D products are at risk of disappearing from the market. These include HIV tests and tests for the safety of blood donations. The proposed deadline extension is therefore a decisive step towards safeguarding healthcare in Germany and Europe and a recognition of the challenges that companies are facing." The VDGH is now appealing to the Council and the European Parliament to approve the Commission's proposal as quickly as possible.
The VDGH also welcomes the early evaluation of the entire medical device legislation. "Despite the deadline extension, fundamental problems remain unresolved. A revision of the legal framework is unavoidable," emphasizes Walger. In order to guarantee the safety of patients, the VDGH is committed to the continuous further development of the IVDR. Together with the German Medical Technology Association (BVMed), a comprehensive white paper was presented to the public in the fall.
