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SynergyBit
Other compliance

IVDR – in vitro diagnostic device compliance

We guide you through the In Vitro Diagnostic Regulation (IVDR) – from classification to CE.

The In Vitro Diagnostic Regulation (IVDR, EU 2017/746) significantly tightened the requirements compared with the previous directive. Now most devices require notified body involvement and considerably more extensive documentation.

Alongside the CRA and MDR, we also work with the IVDR – we help with classification into classes A to D, preparing the technical documentation and performance evaluation and guide you through the path to CE marking. We are not a notified body; we prepare you for one.

What you get

Class A–D classification

Classification of the device per the IVDR classification rules and determination of the corresponding conformity assessment route.

Technical documentation

Preparation of technical documentation per IVDR Annexes II and III – characteristics, safety and device evidence.

Performance evaluation

Support with performance evaluation (scientific validity, analytical and clinical performance) and the post-market performance follow-up (PMPF) plan.

QMS and post-market

Setting up a quality management system (ISO 13485), post-market surveillance (PMS) and vigilance.

How it works

  1. 01

    Assessment and classification

    We determine the device class under the IVDR, the gaps and the scope of documentation needed.

  2. 02

    Documentation preparation

    We compile the technical documentation, performance evaluation and QMS processes to fit you.

  3. 03

    Path to CE

    We prepare you for conformity assessment by a notified body and CE marking.

Outcomes for you

  • A clear classification and regulatory route
  • Complete technical documentation per the IVDR
  • Readiness for a notified body and CE
  • A working QMS and post-market performance follow-up

Frequently asked questions

How does the IVDR differ from the MDR?
The IVDR (2017/746) covers in vitro diagnostic devices (laboratory tests, diagnostic kits), whereas the MDR (2017/745) covers general medical devices. They have different classification and the IVDR requires performance evaluation rather than clinical evaluation. We help determine what applies to your product.
Do we need a notified body?
For most classes (B, C, D), yes – a major change from the previous directive. Only class A (non-sterile) allows self-assessment. We determine the right route based on classification. We are not a notified body; we prepare you for one.
Do you handle IVDR and the CRA together?
Yes. Diagnostic devices with software or connectivity may also fall under the CRA. We can align both frameworks so you do not address the same things twice.

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MDR – medical devices

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Start with CRA before the deadline catches up with you

A free consultation will quickly show you where you stand and the shortest path to compliance.

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