An important achievement—the result of preparation, technical expertise, and strategy—that confirms ECM’s commitment to supporting medical device companies on their journey toward full compliance with Medical Device Regulation (EU) 2017/745.

DEVICES FROM CLASS I TO CLASS IIA (OR HIGHER): WHAT DOES MDR COMPLIANCE REALLY ENTAIL?

With the entry into force of the MDR, many manufacturers found themselves facing a substantial change: devices classified as Class I under the MDD are now reclassified into Class IIa, IIb, or III, subject to 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 NOTIFIED BODY?

With the entry into force of Regulation (EU) 2023/607, new transitional deadlines were introduced for all legacy devices—but only for those who have already initiated 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 uncertainty and potential market disruptions.

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