In-Vitro Diagnostics (IVD) and IVDR

Since the implementation of the new IVD Regulation (IVDR) 2017/746 in May 2022, there have been significant changes in the regulatory landscape of In-Vitro Diagnostics. As a result, over 85% of IVD tests are now classified as high class, necessitating surveillance by a Notified Body and compliance with the IVDR, including for legacy devices during the time period provision. Like in the medical device industry, Eurofins Consulting offers regulatory and quality assurance services tailored specifically to IVDR Manufacturers.

Regulatory Compliance Consultation: Navigating the complex EU IVDR 2017/746 and FDA CFR 820. Assisting in the interpretation and application of IVDR guidelines. Identifying required regulatory actions and providing detailed roadmaps.

Regulatory Strategy: Building and planning regulatory strategy for IVD tests according to the client needs and marketing territory (USA, EU and etc.). Consulting on the best approach to enter the market.

Technical File/Documentation Reviews and Support: Review and guidance on clinical evaluations, post-market surveillance, and performance evaluation reports. Support in generating and maintaining documentation that fulfils IVDR requirements. Continuous training to adapt to any changes in regulations.

Clinical Evaluation Report: Helping IVD manufacturers to establish a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER), including scientific validity, analytical validity and clinical validity.

Risk Management: Assisting in the identification, assessment, and control of risks associated with your devices. Ensuring alignment with ISO 14971.

Quality Management System (QMS): Supporting manufacturers in establishing and improving QMS. Ensuring alignment with ISO 13485 and IVDR requirements. Auditing services (internal, external and supplier audits) to maintain and evaluate the effectiveness of QMS.

Post-Market Surveillance (PMS) & Vigilance Support: Assistance with writing a PMS plan and report, post-market performance follow-up (PMPF), periodic safety update reports (PSUR), and trending analyses. Support in vigilance, incident reporting and trend reporting.

Notified Body Interaction Support: Liaison with Notified Bodies on behalf of manufacturers. Submitting application forms. Assistance during inspections/audits, providing responses, and facilitating communication.

Training and Education: Tailored training programmes on IVDR and regulatory aspects. Continuous training to adapt to any changes in regulations.