June 10, 2025 – The CE certification process for medical devices, particularly under the latest Medical Device Regulation (MDR) of the European Union, now follows a stringent three-phase approach. Diego Stivanella, Regional Manager of ECM, shared that their company, with over 20 years of global experience as a notified body, oversees certification processes for manufacturers worldwide (excluding the US and China), ensuring compliance with international standards.

The three phases of CE certification under MDR are:

Phase One: Submission of the initial application, collection of basic information, and signing of the agreement.
Phase Two: Provision of comprehensive documentation, detailed review of technical files, and notification of related costs.
Phase Three: On-site audit and completion of the final conformity assessment. After a thorough review of all technical documentation and successful audit, the CE certificate is issued.

The issued certificate is valid for five years, with periodic engineering reviews during this period to ensure continuous compliance with updated requirements. These reviews are conducted under the supervision of European authorities.

Stivanella emphasized that, compared to the previous Medical Devices Directive (MDD), the MDR has introduced stricter requirements, more annexes, and a much greater focus on rigorous testing and product safety. For instance, while the term “safety” appeared only 40 times in the MDD, it is referenced over 290 times in the MDR. As a result, the MDR certification process can take up to four times longer than under MDD.

Products certified under MDD must be re-evaluated and updated to meet MDR requirements for new certification. Stivanella highlighted that understanding these changes is crucial for sustained and successful entry into international markets, and ECM offers tailored strategies to expedite certification when immediate market entry is required.

The goal remains to help manufacturers enter global markets quickly and safely by ensuring that all products comply with the latest European standards, supporting long-term market access and patient safety.