The European Commission’s (EC) delays to the implementation of the in vitro diagnostic regulation (IVDR) are creating a drag on IVD innovation in Europe, a regulatory expert has said.
Introduced in 2017, the IVDR, which is positioned as an update and replacement to the EU’s former in vitro diagnostic directive (IVDD), was meant to be in force by 2022.
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Dr Sascha Wettmarshausen, head of regulatory affairs and quality at German trade association Verband der Diagnostica-Industrie (VDGH), said that he had never seen a regulation that has taken so long to be fulfilled.
“This is really a record, and you can see there’s something going definitely wrong with it,” Wettmarshausen said while speaking at the MEDICA convention, taking place in Dusseldorf, Germany between 17-20 November.
Factors including a lack of Notified Bodies – a hurdle that has similarly dogged the EU’s transition to the EU Medical Device Regulation (EU MDR) – and fears that essential tests would disappear from the market if timelines were not extended have meant that multiple readjustments to the originally mooted implementation date have ensued.
Published in July 2024, the EU published legislation to extend the date IVD’s in Europe must be recertified under the IVDR to December 2029 for lower risk IVDs and 2028 and 2027 for medium- and high-risk IVDs, respectively.
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By GlobalDataAccording to Wettmarshausen, some of the “systemic” issues relate to the EC’s overly diligent attitude towards gathering enough data on the overall IVDR certification process. In Germany’s case, there are over 300 pages over guidance around IVDR implementation or adherence.
“It’s a huge bureaucratic overburden,” said Wettmarshausen, highlighting that there also appears not to exist a specific single person that the industry can go to at the EC to seek counsel and clarification. He likens it to there being “no captain on the ship” who would otherwise readily be approached to help solve problems.
The downward trend of IVD innovation
In October, VDGH published a survey along with partners including other trade associations including BVMed and MedicalMountains. The project found that, jointly, the EU MDR and IVDR are dampening innovation and putting the security and supply of medical goods and IVDs at risk.
Wettmarshausen highlighted that among the 245 responding manufacturers form Germany, Austria, and Switzerland, 53% reported reductions in their R&D activities due to the regulations. A separate 40% said they are no longer launching innovations in the EU, yet 60% reported that they are launching innovative IVDs in the US or Asia.
On the plus side, Wettmarshausen said, throughout 2025, the EC has appeared to make moves that suggest they are open and willing to simplify the burden of the originally outlined dictates in meeting the IVDR’s terms.
There is a move from the EC shifting from a “monitoring to reforming” state, he said. Actions have included the EC’s initiation of a public consultation that ran until March 2025 that sought input on streamlining the IVDR rules in their existing state and requesting input on any problems or shortcomings with the factors towards compliance.
