Accelerating the introduction of your SaMD in Europe

You've secured FDA approval for your Software as a Medical Device (SaMD) and are now looking to expand into the European market.

Navigating the CE marking process is a critical strategic move—one that demands a targeted adaptation of your Technical File and Quality Management System (QMS) to ensure seamless market entry.

Adapting your documentation to the MDR 2017/745 requirements

While there are similarities between FDA approval and CE marking, achieving compliance with Regulation (EU) 2017/745 (MDR) requires strategic adaptations. From restructuring your Technical File to aligning your Quality Management System (QMS) with ISO 13485, navigating the CE marking process is a key step to ensuring a smooth and successful market entry. We support you in:

• Identifying the gaps between your FDA submission and the expectations of Notified Bodies.
• Structuring your technical file in alignment with the MDR annexes.
• Adapting your Quality Management System to ISO 13485 standards.
• Preparing your post-market surveillance strategy and incident management framework.

Our offer

1. Classification Strategy Optimization

Medical device classification criteria differ between the FDA and CE marking. While the FDA relies on therapeutic area and market precedents, the European framework classifies devices primarily based on risk level, particularly under MDR Rule 11 for medical software. We assist you in:

• Refining your classification rationale to meet Notified Body expectations.
• Justifying your device positioning in line with MDR requirements.

2. Upgrading to ISO 13485 Compliance

If your QMS is built around FDA requirements, we guide you through the necessary updates to ensure compliance with ISO 13485.

3. Technical File Development and Adaptation

We help you structure your Technical File in compliance with Notified Body expectations, incorporating:

• A clinical evaluation aligned with MDCG guidance.
• A risk analysis integrating ISO 14971 standards.
• Software validation in accordance with IEC 62304.

4. Notified Body Engagement and Audit Preparation

We support you in: 

• Selecting the right Notified Body for your CE marking journey.
• Prepare responses to clarification requests.
• Train your team for the certification audit.
• Assist you during the audit to ensure smooth interactions with the Notified Body.

5. Acting as Your European Authorized Representative

If your company is based outside the EU, appointing a European Authorized Representative is mandatory for MDR compliance.

Sparta Care can act as your Authorized Representative, ensuring direct communication with the Notified Body and managing regulatory obligations on your behalf.

Ready to bring your SaMD to Europe?

Contact us for a consultation and let’s drive your CE marking transition forward together.