nal von minden is calling for an extension to new EU regulations regarding in-vitro diagnostics

nal von minden, a medical technology company from Germany, is calling for an extension to new EU regulations regarding in-vitro diagnostics. Because of the coronavirus, the EU’s original timetable cannot be adhered to. As it stands, all companies that sell in-vitro diagnostics such as rapid tests must re-register their products. This is because the new, stricter EU regulations for in-vitro diagnostics (IVDR) comes into force in May 2022.

“In the interest of all citizens, we believe postponing the deadline for another year to be realistic”, says Dr Gerd Hagendorff, leader of the Quality Management department at nal von minden GmbH. “It would be ideal if the new regulations for in-vitro diagnostics came into effect in 2023, instead of May 2022.”

If not, a bottleneck can be expected with certain products, warns Dr. Hagendorff: “We manufacture 100 tests that are used, for example, in GP practices and hospitals. These include tests for heart attacks and tumour diagnoses. If these tests are no longer available in sufficient numbers, in a worst case scenario we could see delayed diagnoses and treatment.”

This doesn’t only affect nal von minden GmbH, but also many other small-to-medium sized companies, as well as larger firms in Germany and across Europe. “Despite the best efforts of manufacturers, the new IVDR cannot be implemented in the time we have left,” says Dr. Hagendorff.

The original EU timetable was already somewhat ambitious, criticises Dr. Hagendorff. The new regulations for in-vitro diagnostics came into effect EU-wide on 26th May 2017.The trigger was a scandal surrounding breast implants, and security for EU citizens was wanted in the field of medical technology. Since then, manufacturers have had 5 years to implement very time-consuming and labour-intensive changes.

However, even from the beginning, there were not enough so-called ‘notified bodies’ to carry out product testing and with sufficient lead time. “Unfortunately there are only 3 notified bodies available for all manufacturers across Europe who distribute in-vitro diagnostics,” explains Dr. Hagendorff. Even for the more-than 100 products from nal von minden GmbH which need to be IVDR registered, a best case scenario would require over 100 weeks, as the notified body estimates at least 1 week for each product. “This is almost impossible to accomplish by May 2022," he explains.

Due to the pandemic, the timetable cannot be adhered to anymore, says Dr. Hagendorff. “We have pooled our capacities in order to help contain the corona pandemic. We are producing millions of rapid tests every month, so there hasn’t been time to work on the EU regulations.”

“We are in favour of the new regulations, but not under strain and not at the expense of the population,” explains Dr Hagendorff. Furthermore, the same rules should apply to all companies. Last year, in direct response to the corona crisis, the transition period for medical devices according to MDR (Medical Device Regulation, e.g. for pacemakers) was extended by one year.

Hellwig PR
Gabriele Hellwig
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nal von minden GmbH, based in Moers, Germany, has been a specialist in the field of medical diagnostics for 38 years. Its portfolio includes rapid tests and laboratory tests for reliable diagnoses in the fields of bacteriology, cardiology, gynaecology, infectious diseases, urology and toxicology. nal von minden GmbH has a total of about 230 employees at 9 European locations. www.nal-vonminden.com

This release was published on openPR.