The past few weeks have seen some signs of the times regarding the fate of the IVDR (and its companion MDR): A VDGH conference asked in its very title if we are on the way to an “IVDR 2.0,” followed on the heel by a more heavy-weight EPSCO (Council of EU) meeting that tucked an IVDR agenda item into a session on “necessary reforms.”  

Over the past year, papers and “non-papers” have amassed calling for the reform of this complex Regulation: from the MedTechEurope take to the Peter-Liese Initiative, an EU Mission letter, an EU Parliament Resolution, and over the past week: a Team Notified Body paper and the EPSCO paper.

So there we have it: A well-intended Regulation meant to improve the quality of care for EU patients—now headed for reform before most players have found a way to make good on their part. 

Why the outcry? The dominant consensus is that the effects of the Regulation have sent the EU in the opposite direction, namely toward a looming threat of discontinued diagnostic tests and fewer diagnostic innovations reaching EU patients. The expected result: a lower quality of care. 

Reform will likely come slowish, though some still hope to see it in 2025. But the new EU Health Commissioner has been handed the above Parliamentary resolution by Ursula von der Leyen. The idea is to start movement in the right direction asap, rather than waiting for the law to be changed first. 

Some (mostly consensus) points under consideration:  

• A separate process for innovative technologies and esp. rare/orphan diseases 

• Support for SMEs to navigate the complex regulation 

• Various measures to ensure equity in certification processes across EU notified bodies 

• Reform of the 5-year certification cycle  

• Further refinement of the new risk-based classification system, with less scrutiny of low-risk devices 

• Stepped-up global harmonization to make things easier for manufacturers  

One conclusion can quickly be made here: So far very few changes are on the table that will lessen the regulatory load for labs regarding Article 5.5 requirements for in-house devices. While all but the largest manufacturers are raising their voices and suggesting they may turn their backs on the EU market, EU labs committed to serving their patients’ needs have in that sense nowhere else to go. 

Platomics digital solutions make lab compliance easier. 

*We have compiled the above information to the best of our knowledge, yet our blog entries do not constitute expert advice and cannot substitute your own examination of the legal situation applicable to you and your institution.