In Vitro Diagnostic Directive (IVDD) 98/79/EC
The In Vitro Diagnostic Directive (IVDD) 98/79/EC sets forth essential requirements for the safety and performance of in vitro diagnostic medical devices (IVDs) in the European Union. Compliance with IVDD is crucial for manufacturers looking to market their diagnostic products in Europe. Our comprehensive certification services guide you through the regulatory landscape, ensuring that your IVDs meet all necessary standards for safety and efficacy.
Overview of IVDD 98/79/EC
Introduced to ensure the safety and effectiveness of IVDs, the IVDD 98/79/EC outlines requirements for:
- Clinical Performance: Demonstrating that diagnostic devices perform reliably and accurately under expected conditions.
- Quality Management: Establishing a robust quality management system (QMS) in line with ISO 13485 to ensure consistent product quality.
- Labeling and Instructions for Use: Providing clear, informative labeling and user instructions to facilitate safe and effective use of the devices.
- Post-Market Surveillance: Implementing ongoing monitoring and reporting processes to ensure continued safety and performance after market entry.
IVDD Certification Process
Achieving IVDD certification involves several key steps:
- Preliminary Assessment: Identifying the device classification and applicable requirements under the IVDD.
- Technical Documentation Development: Compiling essential documentation, including product specifications, risk assessments, and clinical performance data.
- Quality Management System Implementation: Establishing a QMS that complies with ISO 13485 to manage quality and regulatory requirements effectively.
- Conformity Assessment: Depending on the classification, either self-assessment or third-party assessment by a Notified Body will be required.
- CE Marking: Upon successful completion of the assessment, your device will receive CE marking, allowing it to be marketed in the EU.
- Post-Market Activities: Conducting post-market surveillance and vigilance to monitor product performance and report any incidents.
Importance of IVDD Compliance
Compliance with the IVDD is vital for:
- Market Access: Ensuring that IVDs can be legally marketed in the EU, opening doors to a significant market.
- Patient Safety: Ensuring that in vitro diagnostic products are safe, effective, and reliable for users.
- Regulatory Confidence: Building trust with regulators, healthcare providers, and patients through proven compliance and quality.
- Competitive Advantage: Demonstrating commitment to quality and regulatory standards enhances brand reputation and market positioning.
Our IVDD Certification Services
We provide a range of services to support your IVDD certification journey:
- Consultation Services: Expert guidance on IVDD requirements, device classification, and the certification process tailored to your specific IVD.
- Documentation Assistance: Support in preparing the necessary technical documentation and clinical performance data for submission.
- QMS Implementation Support: Assistance in establishing a quality management system in accordance with ISO 13485.
- Notified Body Coordination: Facilitating communication with Notified Bodies for assessments and audits to streamline certification.
- Training and Workshops: Offering training sessions on IVDD compliance, risk management, and post-market surveillance best practices.
Contact Us for IVDD Certification Assistance
Ensure your in vitro diagnostic devices comply with the In Vitro Diagnostic Directive (IVDD) 98/79/EC. Our experienced team is ready to assist you through every step of the certification process, ensuring a smooth pathway to market access. Contact us today to learn more about our IVDD certification services.
