In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here’s an overview of the process and related forms: Key Forms The Application Process Additional Notes MD-28 Form Structure The exact structure of the MD-28 form can be found on the CDSCO’s SUGAM portal, but…
Purpose and Benefits UDI Issuing Entities in the EU Obtaining and Implementing UDI in the EU Compliance with EU MDR and EU IVDR Key Considerations for Manufacturers MDCG Guidance Documents : Conclusion In the European Union, the UDI system represents a significant advancement in the regulatory landscape for medical devices. It’s aimed at enhancing patient…
Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device’s conformity to the regulations. It’s essential for both pre-market and post-market compliance. This documentation must be readily accessible to regulatory authorities for inspection. Annex II: Technical Documentation Annex III: Post-Market Surveillance System Importance of Technical Documentation The…
It’s a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). It’s a comprehensive database designed to strengthen market surveillance and transparency in the medical device sector in Europe. Registration in EUDAMED is a critical step for manufacturers,…
