MDD-Certified Devices for Joint Pain: MDR Transition Secured

Ensured Continuity: Our Osteoarticular Line Is Ready for the MDR Future

The Medical Device Regulation (MDR), in force since May 2017 and fully applicable as of May 2021, governs medical devices in Europe. Thanks to deadline extensions, devices compliant with the previous MDD Directive may continue to be marketed until December 31, 2027 for Class III and implantable Class IIb products, and until December 31, 2028 for Class IIb, IIa, and Class I.

We have obtained the extension of the MDR transitional period beyond May 26, 2024 for our legacy Class I, IIa, and III devices, confirming our compliance with MDR by submitting certification applications to our Notified Body. We also signed an agreement with the Notified Body to ensure continued market access and ongoing surveillance of every legacy device.

Our Osteoarticular Line: Effective Relief for Muscles and Joints

We have secured the MDD certification extension for our entire osteoarticular line, which includes topical emulgels and sprays. These medical devices are indicated for the treatment of muscular and joint pain, bruises, localized inflammation, and rheumatic conditions. Their effectiveness lies in the synergistic action of plant-based, ozonized, saline, and soothing ingredients that act quickly without systemic side effects.

4 Formulations and Pharmaceutical Forms for Specific Needs

• ATROZONE – Ozonized Emulsion with Anti-Inflammatory Action

Atrozone is a 100 ml emulsion enriched with ozonized olive oil, phytosomal escin, arnica, devil’s claw, hyaluronic acid, and menthol. Its soothing action is beneficial for rheumatic, joint, and muscle pain. The presence of ozonized oil promotes tissue oxygenation, supporting regeneration and skin wellness.

• FLOGOREX EMULGEL – Fast Relief from Contusions and Trauma

A 100 ml emulgel formulated with menthol, camphor, eucalyptus oil, and methyl salicylate, enriched with jojoba oil and vitamin E. Indicated for localized trauma, swelling, tendonitis, and joint pain, it delivers an immediate feeling of freshness and relief thanks to its volatile components. It is quickly absorbed, leaving the skin dry and moisturized.

• FLOGOREX MED SPRAY – Easy to Apply, Effective Against Pain and Inflammation

In 100 ml spray format, this product is ideal for those looking for a fast, contactless application. It contains a synergy of essential oils (rosemary, peppermint), plant extracts (harpagophytum, bromelain), and sodium chloride, useful in treating post-traumatic inflammation, sprains, and joint pain. Its osmotic action helps reduce swelling and inflammation.

• ARTOX GEL – With Glucosamine, Arnica, and Devil’s Claw

A 100 ml topical gel designed to counteract arthritis, rheumatism, tendonitis, and muscle pain. The combination of arnica extract, menthol, camphor, glucosamine sulfate, and ozonized oil supports joint mobility, helping to reduce pain and stiffness. Also ideal for athletes and the elderly.

Your Reliable Partner in the Production of Topical Devices for Joint Pain

We are specialized manufacturers of medical devices. Thanks to our in-house know-how, we offer market-ready products and create customized formulations in private label and contract manufacturing, meeting the specific needs of each customer. Innovation, quality, and safety are the cornerstones of our work, delivering effective, tailor-made solutions.

If you are interested in becoming a private label or out-licensing partner, contact us.