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MDR – medical device compliance

We guide you through the Medical Device Regulation (MDR) – from classification to CE.

The Medical Device Regulation (MDR, EU 2017/745) places strict requirements on manufacturers for safety, documentation and post-market surveillance. Navigating it is demanding, especially for smaller manufacturers and start-ups.

Alongside the CRA, we also work with the MDR – we help you understand the requirements, prepare the technical documentation and clinical evaluation and move through conformity assessment to CE marking. We are not a notified body; we prepare you for one.

What you get

Device classification

Classification into a class (I, IIa, IIb, III) and determination of the corresponding conformity assessment route under the MDR.

Technical documentation

Preparation of technical documentation per MDR Annexes II and III – safety, performance, risks and device evidence.

Clinical evaluation

Support with clinical evaluation and the post-market clinical follow-up (PMCF) 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, the gaps against the MDR and the scope of documentation needed.

  2. 02

    Documentation preparation

    We compile the technical documentation, clinical 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 MDR
  • Readiness for a notified body and CE
  • A working QMS and post-market surveillance

Frequently asked questions

Do you handle MDR and the CRA together?
Yes. For many medical devices with digital elements, the MDR and the CRA meet. We can align both so you do not address the same things twice and responsibilities do not overlap.
Are you a notified body?
No. We are not a notified body or accredited body – we provide advisory and preparation. Third-party conformity assessment for most classes is carried out by a notified body, which we prepare you for.
Can you help with the transition from the MDD directive?
Yes. We help manufacturers transition to the MDR, update documentation and meet the transitional provisions.

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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.

Book a consultation