The medical device sector in Europe is undergoing a period of profound transformation, marked by the strict deadlines and complex requirements of Regulation (EU) 2017/745 (MDR). Recent data reveals a high-pressure environment for both manufacturers and the continental healthcare system, highlighting a critical imbalance between the demand and supply of certification.

A GLANCE AT THE NUMBERS: APPLICATIONS AND CERTIFICATES

Currently, the discrepancy between submitted applications and certificates actually issued represents the main challenge. There are over 28,000 certification applications waiting to be processed, stacked against a limited operational capacity. The 51 Notified Bodies currently active have issued 12,177 certificates—a volume that struggles to cover the immense number of devices requiring the new CE marking to legally remain on the market.

HAVE YOU ALREADY SUBMITTED YOUR DOCUMENTATION TO YOUR NB?

Delaying submission could lead to:

• Notified Body overload

• Delays in assessments;

• Risk of failing to obtain CE certification in due time.

The right time to act is now. Postponing means exposure to regulatory uncertainties and potential market disruptions.

Contact us today to complete your MDR process safely, without setbacks, and with the confidence of having an expert partner by your side.