The IVDR – which stands for In Vitro Diagnostic Regulation – is an EU regulation that has been in place since May 2017 and sets out the rules for so-called in vitro diagnostics (IVDs). These are medical products that analyze samples such as blood, urine or tissue outside the body in order to detect diseases or monitor health status. In Germany, the IVDR has had a major impact on laboratory medicine – i.e. on laboratories that carry out such tests – since its full application on May 26, 2022.

What is the IVDR anyway?

The IVDR is a European Union law that replaces the old rules for diagnostics. There used to be a directive (IVD Directive) that was less strict and gave member states more leeway. However, the new regulation is binding and applies directly in all EU countries, including Germany. Its aim is to improve the safety and reliability of diagnostic tests. Following a number of scandals – such as unsafe breast implants or faulty tests – the EU wanted to ensure that only high-quality and tested products are placed on the market.

The IVDR specifies how such tests must be developed, tested and monitored. It affects manufacturers, but also laboratories that develop their own tests, so-called in-house IVDs. These are tests that are not sold commercially, but are only used in the manufacturer’s own laboratory.

What will change for laboratory medicine?

In Germany, laboratory medicine is a central part of healthcare. Whether diagnosing cancer, infectious diseases such as coronavirus or monitoring chronic illnesses – laboratories provide the basis for many medical decisions. The IVDR now introduces stricter requirements that primarily affect three areas:

1. Higher quality requirements: Every test must prove that it is safe, accurate and useful. This means more documentation and studies before a test is approved. This is a major change for laboratories that develop their own tests, as they now have to meet similar standards as large manufacturers.
   
2. Risk classes: The IVDR divides diagnostics into four classes (A to D), depending on how risky a false result would be. A pregnancy test (class B) has different requirements than a test for life-threatening diseases such as HIV (class D). For higher classes, an independent testing body, a so-called Notified Body, is required. This makes the process more complex and expensive.
   
3. Monitoring after market launch: Even after a test has been approved, it continues to be monitored. Laboratories and manufacturers must collect and report data on how well their tests work in practice. This is to ensure that problems are identified quickly.

Challenges for German laboratories

The IVDR brings both opportunities and difficulties for laboratory medicine in Germany. On the one hand, patients benefit from safer tests – after all, an incorrect result can have fatal consequences. On the other hand, the changeover means a lot of work. Smaller laboratories or hospitals that develop their own tests face particular challenges. They need more staff, money and expertise to comply with the new rules. Some even fear that they will have to give up certain tests if the costs become too high.

Another problem is that there are not enough notified bodies in Europe that can check the tests. This leads to delays, even though the EU has introduced transitional periods – for some products even until 2027 or 2028. Nevertheless, the pressure to adapt quickly remains high.

Why is this important?

The IVDR may sound bureaucratic, but it has a real impact on health. Imagine a corona test falsely showing “negative” even though someone is infected – this puts not only the individual at risk, but entire communities. Or a blood test misses a serious disease because it was poorly developed. The IVDR is intended to minimize such risks.

In Germany, where laboratory medicine already has a high standard, it is also important to maintain this reputation and remain internationally competitive. At the same time, laboratories and authorities such as the Federal Institute for Drugs and Medical Devices (BfArM) must work together to make implementation practicable.

Conclusion

The IVDR is a major step forward for laboratory medicine in Germany. It makes diagnostics safer and more transparent, but also demands a lot from laboratories and manufacturers. It is something of a balancing act: on the one hand, patients should be protected, but on the other hand, care must not suffer. The next few years will show how successful this will be – but one thing is clear: IVDR will have a lasting impact on laboratory medicine.

Matching:

IVDR – The overview – MedLabPortal

Further reading:

• Structure and content of the EU-IVDR | Pathology (springer.com)
  
• EU Regulation on in vitro diagnostic medical devices IVDR | TÜV SÜD (tuvsud.com)

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