Among the first certified in the medical device sector

In 2023, Melody became one of the first medical devices to obtain certification under the new European MDR 2017/745 regulation (Medical Device Regulation). This regulation imposes stricter requirements on manufacturers and distributors to ensure higher safety and performance standards. Without this certification, a medical device cannot be marketed in Europe. The CE marking of AdEchoTech’s remote ultrasound robot places the company among the pioneers in transitioning from the previous directive to the MDR. This recognition attests to Melody’s compliance with the highest standards, AdEchoTech’s expertise in medical innovation, and its strong adaptability.

CE marking of the AdEchoTech Melody remote ultrasound robot, among the first devices certified under the new MDR

AdEchoTech is one of the first companies to comply with the new European regulation for medical devices. By submitting its application as early as April 2022, the company met the deadlines, demonstrating its responsiveness and commitment. A year later, in April 2023, Melody officially obtained CE MDR certification.

This swift recognition reflects the company’s rigor, foresight, and efficiency in a context where transitioning to the new regulation posed many challenges. It illustrates both exemplary adaptability and a strong commitment to providing healthcare professionals and patients with a compliant, reliable, and innovative device.

“In June 2023, the European Commission’s investigation following our certification revealed that only 3,899 certificates had been issued—just 17% of the total had transitioned from the directive to the MDR. We were among the first to complete the migration.”

– Aafaf Marouani,

Director of Regulatory and Quality Affairs at AdEchoTech

The MDR: a new European standard for medical devices

Requirements of the new European medical device regulation

Effective since 2021, the new European Medical Device Regulation (MDR) aims to better ensure patient safety and product reliability throughout their lifecycle. This regulatory framework introduces several key obligations for manufacturers:

• Improved transparency and traceability through the implementation of a Unique Device Identification (UDI) system
• Enhanced clinical testing to demonstrate product safety and efficacy before market entry
• Mandatory post-market surveillance to identify and address any post-commercialization issues
• Detailed technical documentation from manufacturers covering design, manufacturing, and compliance
• Stricter oversight of notified bodies responsible for evaluating and approving medical devices prior to market release

Key MDR implementation dates and deadlines

The MDR (EU Regulation 2017/745) officially came into force on May 26, 2021, replacing the previous MDD (93/42/EEC) and AIMDD (90/385/EEC) directives. Initially scheduled for 2020, its implementation was postponed by a year due to the COVID-19 pandemic to allow better preparation.

Deadlines were later extended to ensure a gradual transition and avoid medical device shortages. Key dates include:

• May 5, 2017: Official adoption of the MDR by the EU
• May 26, 2017: MDR comes into effect, beginning the transition period
• May 26, 2021: End of the initial transition period; MDR mandatory for new devices
• May 26, 2024: End of grace period for certain devices still under valid CE marking (MDD/AIMDD), under conditions
• December 31, 2027: Final deadline for Class III and implantable Class IIb devices with extended timelines
• December 31, 2028: Final deadline for Class IIa, Class I, and some non-implantable Class IIb devices

Which European and international standards does the Melody remote-controlled ultrasound robot meet?

To be MDR-compliant, a medical device must meet various European standards ensuring safety, performance, and regulatory compliance, including:

• Quality management
• Risk management
• Biocompatibility
• Electrical safety
• Usability engineering

Melody complies with the following standards:

EN ISO 13485:2016 / A11:2021	Quality management for medical devices
EN ISO 15223-1:2021	Labeling symbols
EN ISO 14971:2019 / A11:2021	Risk management
EN 62366-1:2015 / A1:2020	Usability engineering
IEC 60601-1:2006 / A2:2021 (Ed 3.2)	Electrical safety
IEC 60601-1-2:2014 / A1:2021 (Ed 4.1)	Electromagnetic compatibility
IEC 60601-1-6:2010 / A2:2021	Ergonomics
EN 62304 / A1:2018	Medical software development
EN 82304-1:2017	Health software safety and performance
EN ISO 10993-1:2020EN ISO 10993-18:2020 :	Biological evaluation and biocompatibility

Why is CE marking essential for medical devices?

CE marking confirms that medical devices like Melody meet the highest standards of safety and quality, building trust among healthcare providers and patients.

It certifies that the device complies with the safety, performance and quality standards imposed by the European Union.

Proof of regulatory compliance

It certifies that the medical device meets the strict requirements defined by the MDR.

Access to the European market

Without this marking, a medical device cannot be marketed or used in Europe.

Performance and safety guarantees

Compliance with standards (ISO, IEC) ensures a high level of quality and reliability for medical devices.

Reinforced post-trade surveillance

The device is subject to continuous monitoring to detect and prevent any potential risks after it has been put into circulation. This monitoring ensures greater safety for users and reliable data for patients, throughout the device’s lifecycle.

The CE marking of AdEchoTech’s remote ultrasound robot confirms its status as a secure and innovative medical device. As the only teleoperated solution of its kind worldwide, Melody reinforces AdEchoTech’s position as a major player in telemedicine and a leader in remote ultrasound. Its deployment significantly improves access to care in the medical deserts and paves the way for a lasting transformation in healthcare delivery.
Discover how AdEchoTech is shaping the future of remote medical imaging with Melody : the remote ultrasound robot.