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 and quality assurance services

Group of people sitting around a table in an office or meeting room with 'Eurofins' and 'Testing for Life' text on the wall. Four individuals are visible with blurred faces; one in the foreground wears a white shirt, and others are using laptops or conversing

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.

Two people sitting in an office or conference room. One wears a light-colored checkered shirt with a lanyard, and the other wears a grey sweater over a blue collared shirt. Large windows and a whiteboard or flip chart are in the background

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.

hree individuals in white lab coats standing in a laboratory. One person is holding a document with a colorful circular pattern on the cover, while the others look at it.

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.

Two individuals standing in front of a whiteboard with handwritten text including 'Quality + Productivity,' bullet points such as 'Project Planning,' 'Right first time,' 'Lean,' 'Supportive Service,' 'Lessons learned,' 'Proud of work,' and the acronym 'PSS

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.

Two individuals in a technical or industrial setting, one standing and one seated, both looking at a computer monitor. Large electrical panels, cables, and a metallic object with an American flag sticker are visible in the background.

Risk Management

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

Two people sitting at a table in an office or meeting room. One, facing the camera, wears a white shirt with red checks and a lanyard, writing on paper. The other, with blonde hair tied back, wears a grey sweater over a blue shirt. An open laptop is on the table, and large windows in the background show grass and trees outside

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.

Two individuals standing in front of a whiteboard, one writing and the other gesturing. Two more people are partially visible in the foreground. The whiteboard displays the text: 'Quality + Productivity - Planning - RURAL FINANCE - LEADERSHIP

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.

Two people sitting at a table in an office environment, both using laptops. The person on the right wears a grey sweater over a blue collared shirt. Large windows in the background let in natural light

Notified Body Interaction Support

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

Group of four people sitting around a table in a meeting or discussion. The person in the center holds a pen and appears to be engaged in conversation. Items on the table include notebooks, pens, coffee cups, and a water bottle. Abstract wall art with circular and curved shapes in blue, orange, and white is visible in the background.

Training and Education

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