IVDR implementation
Patient and user safety is at the heart of all products. This means comprehensive regulation by the legislator, which runs through all process steps. Although the Regulation on in vitro diagnostic medical devices (EU) 2017/746 has been in force since 2017, its implementation is far from complete. The legislator is still revising the guidance and implementation documents and the regulation. In addition, there are German ordinances and laws that are necessary for transposition into German law. Key cornerstones have not yet been finalized by the legislator. In addition, further legislative amendments (AI Act, Machinery Directive, EMC and many more) and standards must be observed. The VDGH supports its members in bundling all information, commenting on current drafts and being the point of contact for all relevant stakeholders.
Highest quality in every step
In addition to the statutory regulations, all areas are subject to a strict quality management and risk management system (QMS and RMS). The QMS standard DIN EN ISO 13485, which is virtually mandatory in the EU, guarantees the safety and effectiveness of products and goes far beyond the ISO 9001 standard used in other sectors. DIN EN ISO 13485 applies to manufacturers in the area of risk management in order to identify, assess and minimize potential risks of in-vitro diagnostics (IVD) for the user. As manufacturers often sell their products worldwide, further QM and RM standards are added. All this makes the products the safest in the world.
Quality management in laboratories
The legislator has delegated the quality requirements for the performance of tests in laboratories to the German Medical Association through the "Guidelines of the German Medical Association for Quality Assurance of Laboratory Medical Examinations". In addition to the professional associations and other stakeholders, the VDGH is also represented on this committee of the German Medical Association as an advisory board member with voting rights. Clear limits are defined here as to which deviations in laboratory results are permissible and in which areas proficiency testing is mandatory.