Obtain IVD Product Certificate with Confidence and Efficiency
Obtain EU market approval for your in vitro diagnostic devices in compliance with the In Vitro Diagnostic Regulation (IVDR – EU 2017/746). clinical evidence, and post‑market surveillance obligations, often with mandatory assessment by a Notified Body.
What is IVDR certification?
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.
Clinical evidence, and post‑market surveillance obligations, often with mandatory assessment by a Notified Body.
Our IVDR Compliance Services
Medunion provides tailored support to ensure your in vitro diagnostic (IVD) devices meet the requirements of the EU In Vitro Diagnostic Regulation (IVDR 2017/746). Our IVDR-specific services include:
IVD Classification
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
Review and refinement of your technical file to ensure alignment with General Safety and Performance Requirements (GSPRs).
Performance Evaluation
Assessment and development of Clinical Evidence Reports and Performance Evaluation Plans.
EU Authorised Representative
Acting as your EU REP to ensure compliance and communication with Competent Authorities.
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.
FAQ
What technical documentation is required under IVDR?
You must have a complete technical file, including device description, design and manufacturing information, performance evaluation (scientific validity, analytical and clinical performance), risk management, labeling, and post‑market plans.
Which types of IVD devices are covered by the IVDR?
All in vitro diagnostic devices such as reagents, kits, control materials, instruments, software, and self‑tests intended for examination of human specimens for diagnostic purposes are in scope.
How do I know the risk class of my IVD under IVDR?
Classification is based on the device’s intended purpose and associated risk to patients and public health, using rules that place products into classes A, B, C, or D; we perform a classification assessment as a first step in any project.
Do I need a Notified Body for my device?
Most devices above class A (and even many sterile class A devices) require involvement of an IVDR‑designated Notified Body for conformity assessment; we help you determine this and select a suitable Notified Body.
What is IVDR performance evaluation and why is it so demanding?
Performance evaluation combines scientific validity, analytical performance, and clinical performance evidence to demonstrate that the device achieves its intended purpose; IVDR significantly raises expectations for the quality and depth of this evidence.
Can you help with legacy devices that were CE‑marked under the IVDD?
Yes. We review existing documentation, identify IVDR gaps, plan transition timelines, and support you in upgrading technical files, PMS systems, and labeling so your legacy devices remain on the market.
What support do you offer after CE marking?
We help implement and maintain post‑market surveillance (PMS), vigilance, and periodic safety update reporting, and we assist with change management so modifications stay compliant with IVDR and Notified Body expectations.
How long does an IVDR conformity project usually take?
Timelines vary by device class and starting point, but manufacturers should expect several months to over a year from initial gap analysis to successful Notified Body certification, so early planning is essential.
Streamlined Compliance for the European Market
Reliable Representation for EU Regulatory Affairs