Germitec Announces CE MDR Certification for its Chronos® Device

 Germitec announces CE MDR Certification for its Chronos® device

A strategic milestone supporting Germitec’s European expansion and strengthening its position as a trusted partner for healthcare facilities in infection control.

Press Release – Bordeaux, France – May 22, 2025. Germitec, a leading MedTech company specializing in UV-C High-Level Disinfection (HLD) solutions for ultrasound probes, announces that its Chronos® device has received CE^[1] certification under Class IIb^[2], in accordance with the new European Medical Device Regulation (MDR 2017/745), replacing the previous Medical Device Directive (MDD 93/42/EEC).

This certification confirms Chronos’s® compliance with the highest European standards for patient safety, clinical performance and regulatory traceability. With the successful completion of the rigorous quality process initiated in April 2024, this regulatory milestone reinforces Germitec's position as a key player in the European medical device market for Healthcare-Associated Infections prevention.

A rigorous regulatory certification
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Transition from MDD to MDR^[3] directive is a significant step in Medical Device European regulation. Through this process, Chronos® now meets the most stringent MDR requirements in terms of safety, performance, clinical evaluation and traceability. Classified as a Class IIb medical device, Chronos® is recognized as a High-Level Disinfection (HLD) system for endocavity and external ultrasound probes used in invasive or semi-invasive medical procedures.

The device underwent a comprehensive assessment by the notified body GMED :

●  including certification of a quality management system in line with MDR Article 10,

●  an in-depth review of technical documentation,

●  a rigorous clinical evaluation,

●  registration in the EUDAMED database for traceability,

●  appointment of a Person Responsible for Regulatory Compliance (PRRC),

●  and implementation of post-market surveillance (PMS) and vigilance systems.

Already CE certified under former MDD 93/42/EEC directive, the CE MDR marking grants official authorization for Chronos’s® marketing in Europe. It certifies that the device complies with current MDR 2017/745 requirements and meets the expected standards for High-Level Disinfection. Device’s design, performance or safety haven't been modified, updates have only been made to labelling and user manual.

Vincent Gardès, CEO of Germitec said — “Obtaining the CE MDR certification for Chronos® highlights our regulatory rigor and commitment to offering disinfection solutions that are compliant, efficient and adapted to infection prevention and control.”

An innovative technology enhancing infection prevention

Chronos® integrates Germitec’s patented Yuvee® technology, enabling fast, automated and reproducible disinfection in about 90 seconds— chemical-free solution, with complete traceability. This technology uses ultraviolet type C (UV-C) irradiation and demonstrates efficacy against bacteria, fungi, viruses (including HPV and HIV), mycobacteria, and spores. With global demand for infection prevention on the rise, Germitec’s solution is well-positioned to address critical needs to support infection prevention and control.

For 20 years, Germitec has continuously developed UV-C products to kill pathogens, improve patient safety, and operational efficiency.

A strategic step to support European and global expansion

Following its €29 million Series B fundraising round in February 2025, the CE MDR certification marks a key milestone in Germitec’s growth strategy.The company's position is strengthened  in Europe  and paves the way for future international regulatory approvals. By offering an all-in-one solution that is significantly faster, sustainable, cost-effective, repeatable and traceable, Germitec positions itself as a go-to partner for healthcare institutions looking to enhance patient safety and infection prevention.

“This certification is more than a regulatory step, it’s a strong message to our European partners and customers. A key driver for accelerating our growth in the European markets, and a springboard for future international regulatory initiatives. This achievement aligns with our mission providing healthcare facilities with a trusted option to protect their patients across all departments where ultrasound exams are performed.” concluded Vincent Gardès, CEO of Germitec.

Key Figures:

●  Available in over 40 countries

●  Over 2.2 million patients protected

●  More than 2,500 units installed worldwide

●  UV-C solutions used in Gynecology & ART | Cardiology | Urology | ENT | Radiology | Emergency Medicine | Anesthesiology | Biopsy

●  Chronos® received FDA grant for US marketing on August 28th, 2024

●  €29M Series B funding in February 2025

●  €25M financing from the European Investment Bank in November 2023

●  €11M fundraising in 2022

●  Winner of the 2020 Prix Galien France for Chronos®

About Germitec

Germitec is a MedTech company dedicated to designing and manufacturing advanced UV-C disinfection solutions for healthcare environments. Its innovative products aim to reduce healthcare-associated infections while streamlining workflow and ensuring safety. Germitec is committed to delivering reliable, eco-friendly, and effective solutions that meet the highest standards of care.

For more information, visit www.germitec.com and connect with us on LinkedIn and X.

Press Contact – Madame de la Com’:

Ophélie Moreau - ophelie@madamedelacom.com : +33 6 32 50 77 30

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^[1] The CE marking (Conformité Européenne) is a regulatory label indicating that a product complies with the general safety and performance requirements of the applicable regulations. It is mandatory for certain products marketed within the European Economic Area (EEA).

^[2] Definition of Class IIb according to Rule 16 of Annex VIII of the MDR: All devices specifically intended to be used for disinfecting or sterilizing medical devices fall under Class IIa, except when they are disinfectant solutions or washer-disinfectors specifically intended for disinfecting invasive devices at the end of the process, in which case they fall under Class IIb.

^[3] MDR 2017/745 is the new regulation on medical devices that replaces the previous Medical Device Directive (MDD 93/42/EEC) in Europe.

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