Bentrio Achieves EU MDR Certification — A Big Step Forward for Allergy Protection
Altamira Medica reached an important milestone: Bentrio®, the drug-free nasal spray for protection against airborne allergens, is now officially certified under the European Union Medical Device Regulation (MDR). This certification declares Bentrio’s conformity with the EU’s new rigorous requirements for demonstrating and ensuring the safety, performance and quality of medical devices. Further, it will support its ongoing expansion in Europe and worldwide.
Why MDR Certification Matters
The MDR framework sets a far higher bar for demonstrating safety, performance and manufacturing quality than the previously applicable Medical Device Directive (MDD). Nasal sprays such as Bentrio, previously classified as self-declared Class I devices, are now regulated as Class IIa device, requiring independent review by a designated Notified Body.
With the certification completed, Bentrio can now be commercialized in all EU member states under the new rules, bearing the “CE mark”. The certification also serves as a recognised quality and safety reference for several regulatory authorities outside Europe, easing approval procedures in additional markets.
Built on Solid Clinical Evidence
Bentrio’s CE marking under MDR is supported by four clinical studies evaluating efficacy, safety and quality of life improvements. The largest study, NASAR, enrolled 100 patients with seasonal allergic rhinitis and compared Bentrio with saline over two weeks of treatment. The results demonstrated:
• A statistically significant improvement in reflective Total Nasal Symptom Score (rTNSS)
• Highly significant improvements in health-related quality of life
• Better global efficacy ratings from both patients and investigators
• Fewer symptom-relief medications used by Bentrio-treated patients
• Symptom-free days occurring more frequently with Bentrio
Taken together, these results confirm both the protective mechanism and the daily usability of the product which – importantly – does not contain any preservatives or drugs.
Why This Matters for You
Bentrio works by forming a gentle, protective gel layer in the nose. This layer traps airborne allergens and supports their natural removal. With MDR certification, users can be confident that the product is backed by modern safety standards and solid clinical data.
Looking Ahead
This milestone strengthens Bentrio’s position in Europe and supports our international growth. We remain committed to helping people breathe easier — naturally and effectively.
