Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers


Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers

We have some fantastic news for all medical device manufacturers out there! The European Commission has just released the results of a recent survey that sheds light on the progress of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) transition. And guess what? The results are incredibly promising!

Discover the Latest Survey Results

The survey, conducted by the Austrian National Public Health Institute, Areté, and Civic Consulting, provides an overview of the MDR/IVDR transition process as of March 2023. The data shows a significant increase in both MDR and IVDR applications and certificates compared to October 2022.

MDR Applications have seen a remarkable surge of over 40%, reaching a staggering 11,418 applications!

Not to be outdone, MDR Certificates rose by almost 50%, reaching a total of 2,951 by March 2023!

The survey also reveals a positive trend for IVDR, with applications received by Notified Bodies rising by over 15%, and the number of issued certificates increasing by 24% during the same period!

While we celebrate these promising figures, it’s crucial to approach the news with some caution, as experts advise. The survey might not fully reflect the potential impact of the MDR extension that went into effect in March 2023.

Nevertheless, this progress is encouraging, and it’s essential for manufacturers to stay proactive and maintain effective communication with Notified Bodies during the recertification process.

As we move forward, embracing innovation and ensuring compliance, we can’t wait to witness even more positive developments in the medical device industry! Let’s keep our focus on creating safer and more innovative healthcare solutions for a better tomorrow.

Stay tuned for further updates and explore the detailed survey results HERE!


For more news and updates from the medical device industry, be sure to check out MDSS News