Do IVDR Annex IX Chapter II certificates apply to Class C devices?
You won’t get a product-specific (Annex IX Chapter II) certificate for a Class C device. Those certificates are only issued for Class D devices. For
Type at least 3 characters to search
Iberania is a Madrid-based contract research organisation specialising in medical devices, IVDs and medical technology. It combines clinical research with regulatory consulting for EU MDR and IVDR market access. Services include regulatory roadmaps, technical-documentation preparation, clinical evaluation and evidence planning, investigations and post-market surveillance support. The company works with startups and established manufacturers and reports experience across clinical and regulatory projects in multiple international markets.
You won’t get a product-specific (Annex IX Chapter II) certificate for a Class C device. Those certificates are only issued for Class D devices. For
Dr. Oliver Eidel
Dr. Oliver Eidel