IVDR Compliance
CE marking is mandatory for all in vitro diagnostic (IVD) devices placed on the European market. It signifies that the device complies with applicable EU legislation and can be legally commercialized across the European Economic Area (EEA).
Previously regulated under the In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC), IVD devices are now subject to the more stringent requirements of the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746), which became fully applicable in May 2022.
Under the IVDR, manufacturers must meet enhanced standards related to safety, performance, clinical evidence, and post-market surveillance. The new regulation also significantly expands the scope of IVDs requiring Notified Body involvement, making expert regulatory support more critical than ever.
IVD Classification under the IVDR
The In Vitro Diagnostic Regulation (IVDR 2017/746) introduces a new, risk-based classification system for IVD devices, replacing the previous self-certification model under the IVDD. Devices are now classified into four classes — A, B, C, and D, based on their intended use and potential risk to patients and public health.
Class A
Low individual and public health risk (e.g., laboratory instruments, specimen receptacles)
Class B
Moderate individual risk, low public health risk
Class C
High individual risk, moderate to high public health risk (e.g., self-testing devices, infectious disease tests)
Class D
High individual and public health risk (e.g., HIV, hepatitis testing)
EU IVD Registration Support
As part of our IVD compliance and registration services, Medunion provides expert support to ensure your in vitro diagnostic devices meet the applicable European regulatory requirements. Our services include:
- IVD Classification & Regulatory Strategy
Guidance on correct device classification and conformity assessment routes under IVDR. Testing Standards & Guidance Identification
Support in defining applicable standards, IVDR requirements, and relevant MDCG guidance.Technical Documentation & Gap Analysis
Review and refinement of your technical file to ensure alignment with General Safety and Performance Requirements (GSPRs).Clinical Evidence & Performance Evaluation
Assessment and development of Clinical Evidence Reports and Performance Evaluation Plans.Notified Body Support
Assistance with Notified Body selection and coordination for IVDR conformity assessments.EU Authorised Representative Services
Acting as your EU REP to ensure compliance and communication with Competent Authorities.Risk Management
Risk analysis and documentation in line with EN ISO 14971.Post-Market Surveillance & Vigilance
Setup and improvement of PMS and vigilance systems in compliance with IVDR obligations.QMS Implementation (ISO 13485)
Alignment of your quality system with ISO 13485:2016, including audit preparation and hands-on support.
