Are you compliant with the latest EU MDR/IVDR requirements?

The EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) involve for organizations.

EU Medical Device Regulation (MDR) Compliance

The EU MDR, which came into full effect on May 26, 2021, has significantly increased the requirements for medical device manufacturers to ensure a higher level of patient safety and product quality. Here are the key components of compliance:

1. Increased Clinical Evidence: Manufacturers must provide more comprehensive clinical data to support the safety and efficacy of their devices.
2. Post-Market Surveillance: Enhanced requirements for monitoring the performance and safety of devices after they are brought to market.
3. Quality Management System: Organizations must maintain a robust Quality Management System (QMS) that complies with the regulation, typically aligned with ISO 13485.
4. Technical Documentation: Expanded requirements for documentation, including a detailed description of the device, its manufacturing process, and proof of conformity.
5. Unique Device Identification (UDI) System: Implementation of a UDI system to improve device traceability.
6. Notified Body Interaction: Increased involvement with Notified Bodies for the conformity assessment of higher-risk devices.
7. Economic Operators: Clear responsibilities defined for manufacturers, importers, and distributors.

EU In Vitro Diagnostic Regulation (IVDR) Compliance

The IVDR, which will be fully applicable by May 26, 2022, for in vitro diagnostic medical devices, introduces similar increases in regulatory demands:

1. Classification System: IVDR introduces a new risk-based classification system for IVDs, requiring different levels of conformity assessment based on the associated risk.
2. Clinical Evidence: More stringent requirements for clinical evidence supporting the safety and performance of IVDs.
3. Performance Evaluation: A comprehensive performance evaluation report is required, detailing scientific validity, analytical performance, and clinical performance.
4. Post-Market Performance Follow-up: Systematic collection and evaluation of data on device quality, performance, and safety throughout their lifecycle.
5. Notified Bodies: Greater involvement and scrutiny from Notified Bodies, including unannounced audits.
6. QMS Requirements: Enhanced Quality Management System requirements, closely aligned with ISO 13485.

For both MDR and IVDR, compliance is a continuous process that involves regular updates to regulatory documents, consistent engagement with regulatory bodies, and ongoing vigilance to adapt to any changes in the regulatory landscape or market environment.

If you are associated with a company or organization that is working towards compliance, it would be essential to collaborate closely with legal and regulatory experts to ensure all aspects of the regulations are addressed adequately.