The European Union’s IVDR (2017/746) regulation has fundamentally changed the approach to conformity for in vitro diagnostic devices. Demonstrating basic conformity is no longer enough; devices are expected to provide continuous evidence of performance both before and after they are placed on the market.

For manufacturers, importers, authorised representatives and other economic operators, this new regulation means more detailed technical documentation, stronger performance evaluation and more effective post-market surveillance systems. With our expert team, we help you manage your IVDR transition in a planned, controlled and sustainable way.

What does the IVDR change?

  • The risk-based classification system has become more comprehensive.
  • The requirement for clinical and performance evidence has increased significantly.
  • Notified Body audits have become more detailed and more stringent.
  • The content of the technical documentation has become much broader.
  • Post-Market Surveillance (PMS) and trend reporting processes have become mandatory.

In short, the “certificate obtained, process complete” approach has given way to monitoring the safety and performance of the product throughout its entire life cycle. IVDR compliance is therefore not only a legal requirement; it is also a strategic step towards credibility in the market and sustainable growth.

Our scope of services

1. Risk classification

We make sure your devices are assessed correctly against the IVDR classification rules. By determining whether your product falls into Class A, B, C or D, we clarify the conformity assessment route that applies.

  • Product-based classification analysis
  • Assessment against the IVDR classification rules
  • Reducing the risk of misclassification
  • Identifying the Notified Body requirements

2. Technical documentation update

The scope and depth of the technical documentation are critical for IVDR compliance. We help you structure your technical documentation according to current regulatory requirements, identify gaps and strengthen the document set.

  • General Safety and Performance Requirements (GSPR) mapping
  • Review of product description, design, manufacturing and verification records
  • Integration of the risk management and usability files
  • Checking labelling and instructions for use against the IVDR

3. Performance Evaluation Reports (PER)

One of the most critical parts of the IVDR is the preparation of the Performance Evaluation Report (PER), which clearly demonstrates the scientific and technical performance of the product. We set up the data structure, gap analysis and reporting framework your product needs.

  • Evaluation of scientific validity data
  • Documentation of analytical performance data
  • Analysis of clinical performance data
  • Aligning the PER structure with IVDR expectations

4. Post-Market Surveillance (PMS)

Under the IVDR, conformity is not limited to market entry. Once the product has been placed on the market, its performance, safety and trends must continue to be monitored systematically. We help you set up your post-market surveillance structure.

  • Creating the PMS plan and PMS report structure
  • Defining trend reporting processes
  • Systematic tracking of feedback and nonconformity data
  • Structuring PMPF and continuous performance monitoring processes

Why should you get IVDR consulting?

Incorrect classification, incomplete technical documentation, insufficient performance data or a weak PMS structure can delay your product’s access to the market, complicate your certification process and create serious risks during audits.

IVDR compliance should therefore not be seen merely as a document preparation exercise; it should be treated as a systematic transition project for the sustainability of your product in the European market.

Our strategy

We do not see regulatory changes merely as a burden to be fulfilled.

A well-managed IVDR compliance process increases the reliability of your product, strengthens your position in the European market and gives your brand a quality-driven competitive advantage.

Contact us

Contact us to manage your IVDR (2017/746) process professionally, bring your devices into line with the new regulation and gain a stronger position in the European market. The details of our scope of services are on our IVDR Consulting page.

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The IVDR is no longer just a regulation; it is the foundation of your product’s credibility in the market.