The European IVDR Directive represents a profound change for the in-vitro diagnostics industry. Manufacturers, specialists and healthcare facilities must adapt to stricter requirements, new classifications and a higher documentation effort. This upheaval brings with it not only challenges, but also opportunities for innovation, quality and personnel development.
With the IVDR, i.e. the In-vitro Diagnostic Medical Devices Regulation (EU 2017/746), the European Union is replacing the previous Directive 98/79/EC. The aim is to increase patient safety, strengthen clinical evidence and make market surveillance in Europe more uniform.
However, getting there is complex. The 200 or so manufacturers in Germany, many of which are SMEs, have to make considerable investments in processes, documentation and specialist staff. According to a survey by the industry association BVMed, more than 70 percent of BVMed member companies have discontinued individual medical devices or entire product lines due to the new regulations.
A key difference to the old IVD Directive is the new classification system. Previously, around 80 percent of products could be placed on the market without external testing. Now, however, many products fall into classes B, C or D, meaning that the involvement of notified bodies is required.
In concrete terms, this means for manufacturers:
Managers are faced with the challenge of adapting existing processes while at the same time driving forward the development of new products. Applicants with experience in regulatory affairs or quality management and knowledge of the IVDR directive are therefore particularly in demand.
The implementation of the IVDR Directive requires well-coordinated teamwork. Employees with regulatory expertise, technical understanding and a clear view of international market requirements are in demand. Companies that hire or train appropriate specialists at an early stage secure an important competitive advantage.
Practical examples show that targeted investment in further training and external expertise can help turn regulatory hurdles into opportunities for innovation. Established manufacturers of medical technology are therefore increasingly working with specialized partners. This enables them to avoid staff shortages and at the same time further develop their product portfolios in compliance with the IVDR.
Despite staggered transition periods, there is little time left. For products in the highest risk class D, the deadline is May 2025; for the other classes, the transition period ends in 2028 at the latest. However, it is possible to extend the transition period further by submitting a corresponding application. If you act now, you can avoid costly delays.
The following steps have proven successful in practice:
Start the gap analysis: Check the technical documentation, post-market surveillance and clinical evaluation data.
Adapt QMS: Update your quality management system in accordance with ISO 13485 and integrate the requirements of the IVDR.
Revision of the product classification: Many products have now been categorized in a higher risk class. A new assessment is therefore crucial.
Introduce a UDI system: Ensure clear and transparent product labeling that can also be implemented internally.
Use resources in a targeted manner: Build up internal expertise, recruit experienced specialists and call in external support if necessary.
The IVDR Directive is more than just a bureaucratic requirement. If implemented correctly, it strengthens confidence in diagnostic products, creates a level playing field and raises quality to a new level. Companies that actively use regulatory know-how secure long-term competitive advantages.
The IVDR Directive leads to greater complexity in in-vitro diagnostics, but also creates a clear framework. Companies should use this time to adapt their structures and processes and reorganize their personnel. Investing now will not only strengthen your own compliance, but also your company's ability to innovate.
Are you looking for experienced specialists and managers in the fields of regulatory affairs, quality management or clinical evaluation in connection with the IVDR Directive? The recruitment consultants at BESTMINDS have in-depth market knowledge and a specialized network in the medical technology, healthcare, life sciences / pharma and IT / media sectors. We find the right personalities for your challenge. Contact us for a non-binding initial consultation!
