Implementing and maintaining a quality management system (QMS) is mandatory for manufacturers looking to market and sell medical devices in the EU. Several new QMS requirements have been introduced under the IVDR. These new requirements will apply to both existing and new devices that are brought to market.
The QMS should address the following under the new regulation:
Arena QMS Tip:
Quality TemplatesLeverage the Arena quality templates to develop the necessary quality processes and procedures for your QMS. Once created, these documents are linked to your product record and show the history of any changes that are made. Documents can be easily exported for review by your notified body.
Section 2: Key Changes Under New IVDR
Economic Operator Roles and Responsibilities
Performance Evaluations, Performance Studies, and Post-Market Performance Follow-up
Post-Market Surveillance (PMS)
European Database for Medical Devices (EUDAMED)
Section 3: Quality Management System (QMS) Requirements
Section 4: Steps For A Successful EU IVDR Implementation