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EU IVDR Compliance Services
Ensuring alignment with the European Union In Vitro Diagnostic Regulation (EU IVDR) 2017/746 is essential for manufacturers aiming to market their IVD products within the EU. Pharma Wizard brings specialized expertise in designing IVDR transition strategies, overseeing submission processes, managing Health Authority (HA) queries, and delivering end-to-end support to help manufacturers achieve timely and complete compliance.
EU IVDR Compliance Services Overview
The European In Vitro Diagnostic Regulation (EU IVDR) introduces a new regulatory framework for placing IVD devices on the EU market. It will replace the existing Directive on in vitro diagnostic medical devices (EU 98/79/EC). As an EU regulation, it will automatically apply across all EU Member States and EFTA countries without requiring national transposition. As a trusted Regulatory partner, Pharma Wizard offers comprehensive EU IVDR compliance and consulting services to support manufacturers in achieving CE marking and meeting the new IVD requirements.
The IVDR Regulation - Transition Timeline
Mandated to be effective from May 26, 2022, the new EU IVDR is considered as a significant change to the Regulatory oversight of IVDs. Overview of the IVDR transition is as below ā
Once fully enforced, IVDR compliance requirements ensure that nearly all IVDs entering the EU market undergo review by an IVDR Notified Body (NB) and obtain CE marking as part of the IVD approval pathway. Under these updated regulations, manufacturers must promptly align with the new IVDR classification system and thoroughly assess all critical technical documentation to achieve successful IVD registration and CE certification. IVDR expectations vary depending on the deviceās risk class. In general, to obtain IVD certification, manufacturers are required to:
- Conduct technical file reviews in accordance with IVDR (Regulation EU 2017/746)
- Prepare a Performance Evaluation Report (PER) for each IVD product
- Implement Post-market Performance Follow-up (PMPF) based on Annex XIII Part B of IVDR
- Carry out Vigilance Reporting under Article 82 of the IVDR
Pharma Wizard assists clients in systematically reviewing scientific literature and supports the development and submission of PERs to meet IVDR standards. Pharma Wizard also provides expert IVDR consulting and Post-market Surveillance (PMS) support, which is a critical component of a manufacturerās quality management system alongside PMPF.
EU MDR Compliance Services
- Expertise
- Advantages
- Transition plan for the IVDR compliance
- Technical review and gap analysis of the IVDR requirements for GSPR (General Safety and Performance Requirements)
- Support the compilation of the technical file as per the IVDR requirements
- Scientific validity reports based on literature and/or in-house data
- Clinical performance reports based on literature and/or in-house data
- Clinical evidence or Performance Evaluation reports
- Post-market Performance Follow up (PMPF) protocols and reports
- Post-market Surveillance (PMS) protocols and reports
- Writing/revising other documents such as package insert/IFU (Instructions for Use), Quick Reference Instructions (QRI), Operation/User Manual etc.
- Assured IVDR compliance, IVD registration, and CE marking
- Strong Regulatory understanding and expertise in the EU IVDR key impact areas
- Strong project management driven delivery model to ensure schedule adherence
- In-house NB Experts (review of the report by the NB interactive reviewers)
- Focused teams with cross expertise on specific impact areas and device categories
- Cross-functional inputs from medical device experts to comply with requirements
- Full scope of service across compliance, review and planning
- Strong expertise in maintaining consistency in deliverables (Time and Quality)āÆ