Failure to promptly comply with the requirements of the MDR Regulation—which stipulates more robust technical documentation, the application of new classification rules, and a more rigorous post-market surveillance system—will inevitably result in products being excluded from the European market.

CLASS I TO CLASS IIA (OR HIGHER) DEVICES: WHAT IS REALLY CHANGING?

With the entry into force of the MDR, many manufacturers have faced a substantial change: devices classified as Class I under the MDD are now reclassified as Class IIa, IIb, or III, with much stricter requirements.

WHO IS INVOLVED?

• Medical software

• Reusable surgical instruments

• Devices with measuring function

• Long-term invasive products

All typical cases of reclassification, which now require mandatory assessment by a Notified Body (NB).

HAVE YOU ALREADY SUBMITTED THE DOCUMENTATION TO YOUR NB?

With the entry into force of Regulation (EU) 2023/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process.

Delaying submission could lead to:

• NB overload
• Delays in assessments
• Risk of not obtaining CE certification in time

The right time to act is now.
Delaying means exposing yourself to regulatory uncertainties and possible interruptions in marketing.

Contact us today to complete your MDR process safely, without any unexpected surprises and with the certainty of having an expert partner at your side.