Medical Devices

Your partner for Pre- and Post-market Clinical Investigations

The new Medical Devices Regulation (EU) 2017/745 (MDR) has been fully applicable since 26 May 2021 in order to create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.

This new framework sets high standards of quality and safety for medical devices:

• Increases requirements for clinical evidence and user safety
• Raises standards for technical data mandatory for marketing and clinical investigation application of class I to II medical devices
• Ensures the reliability and robustness of data in clinical investigations
• Ensures the safety of subjects participating in clinical investigations.

With more than 30 years’ experience in testing medical devices, we have eight research centers acting as CRO and CRC to assist with the different steps of setting up of your clinical investigations: 

• Employees trained on the Medical Devices Regulation and guidelines
• Several applications according to the new regulation successfully completed (mono- and multi-centric; mono- and multi-national)
• Database of qualified investigators and sites for use of medical devices established (including key opinion leaders for different indications)
• Access to global database of healthy subjects or patients (different ethnic groups, various inclusion criteria / pathologies / medical practice habits)
• Full-CRO with in-house medical experts dedicated to medical device use
• Process for SAE management and reporting in place
• Full-service capacity for investigations according to the regulation (including project management, specialised regulatory submission management, data capture and management, statistical planning and analysis, medical writing)
• In-house clinical trial facility with expertise in medical device investigations.

Services are performed according to Chapter VI and Annex XV of the Regulation in order to complete your Clinical evaluation report or Post-market Clinical Follow-up. As an accredited and state-of-the-art laboratory, we guarantee total compliance with new requirements of regulation and with ISO standard 14155:2020 (Clinical Investigation of Medical Devices for human subjects – Good Clinical Practice), ethical principles and General Data Protection Regulation standards.

In addition to clinical testing, Eurofins companies are your Global Testing Partners, offering further testing services to launch your medical devices products on the market: analytical chemistry, microbiology, biological evaluation, packaging, utilities, material analyses, electrical safety testing, cyber security, CE marking.  

Within the Eurofins network of laboratories, we provide a broad range of services, including certification and Notified Body services. Notified Body services, and any services related to the activities of EU Notified Bodies, are only provided by Eurofins Product Testing Italy Srl (NB No. 0477), Eurofins Electric & Electronics Finland Oy (NB No. 0537) and Eurofins Product Service GmbH (NB No. 0681).

To prevent any conflict of interest, or perception of conflict of interest, we are unable to provide certain services to Notified Body customers. For more information, please contact our Medical Device Certification team at EENBServices@eurofins.com.