What are MDR and IVDR Parameter Cards?

Compliance with European Union legislation is crucial for medical device manufacturers and importers. Under the MDR (Medical Device Regulation - 2017/745) and IVDR (In Vitro Diagnostic Regulation - 2017/746) regulations, parameter cards are used to document the safety and performance of products. These cards are included in the device's technical file and demonstrate how the product meets regulatory requirements.

The Importance of MDR and IVDR Parameter Cards

The MDR and IVDR regulations contain strict regulations to ensure the safe circulation of medical devices and in vitro diagnostic devices on the European market. Parameter cards play a critical role in this process:

Product Compliance: Documenting the device's compliance with MDR or IVDR regulations.

Risk Management: Identifying the device's potential risks and taking appropriate measures.

Clinical Evaluation: Providing scientific evidence regarding the product's safety and effectiveness.

Regulatory Audits: Providing information requested by notified bodies during audit processes.

MDR Parameter Card Contents

For medical devices subject to the MDR regulation, the parameter card includes the following information:

Device Description

Product name and model

Intended use

Device classification (Class I, IIa, IIb, III)

Technical Specifications

Material information

Lifespan

Electrical and mechanical properties

Risk Management

ISO 14971-compliant risk analyses

Hazard identification

Clinical evaluation and testing

Biocompatibility tests

Performance and safety tests

Declaration of conformity and documentation

CE certificate

User manual and labeling information

IVDR Parameter Card Contents

For in vitro diagnostic devices, the IVDR parameter card includes the following:

Product Description

Test name and purpose

Sample type (blood, urine, tissue, etc.)

Device class (A, B, C, D)

Analytical Performance

Sensitivity and specificity values

Measurement accuracy and reproducibility

Clinical Performance

Clinical sensitivity and specificity studies

Reference intervals

Risk Management and Safety Measures

Potential risks and mitigation strategies

Conformity assessment procedures

Regulation and Documentation

Technical file references

CE marking and declaration of conformity

Preparation of MDR and IVDR Parameter Cards

Complete and accurate preparation of parameter cards is crucial for the CE certification process. Important points to consider during this process:

Correct product classification

Ensuring compliance with current regulations

Complete risk management and clinical evaluation studies

Preparation of documents in accordance with audit procedures

If you need support with the preparation of MDR and IVDR parameter cards, Medex Corporate Consulting offers its expert team. We are here to assist you with your ÜTS registration and CE certification processes!