Entering the European market is a strategic milestone for any medical device company — but without full compliance with the EU Medical Device Regulation (MDR 2017/745), that milestone can quickly become a roadblock. With deadlines enforced and Notified Bodies applying rigorous scrutiny, proactive preparation is no longer optional.

At MHP, we’ve guided dozens of global manufacturers through successful MDR transitions. Based on real-world experience, here are the 7 critical steps you must take to achieve — and maintain — MDR compliance.

1. Confirm Your Device Classification Under MDR

The MDR reclassified many devices, often placing them in higher risk categories. Start by accurately determining your device’s class (Class I, IIa, IIb, or III) based on Annex VIII of the regulation. Misclassification is one of the top reasons for delays in certification.

💡 Tip: Software as a Medical Device (SaMD) and devices with drug combinations now face stricter rules — double-check if your product falls under expanded MDR scope.

2. Appoint a Qualified EU Authorized Representative

If your company is based outside the EU, you must designate an EU Authorized Representative (EC Rep). This entity acts as your legal contact for authorities and ensures your technical documentation is available for inspection.

⚠️ Note: Your EU Rep must be listed on your device labeling and Declaration of Conformity. Choose a partner with regulatory expertise — not just a legal mailbox.

3. Conduct a Gap Analysis of Your Technical Documentation

MDR demands significantly more robust technical documentation than the old MDD. Review your files against Annexes II and III, paying special attention to:

• Clinical Evaluation Reports (CERs)
• Risk management (ISO 14971)
• Post-Market Surveillance (PMS) plans
• Unique Device Identification (UDI)

📌 Many manufacturers underestimate the depth of clinical evidence now required — even for legacy devices.

4. Update Your Clinical Evaluation

Under MDR, clinical data must be proportionate to risk and continuously updated. For higher-class devices, you may need new clinical investigations. Ensure your CER follows MEDDEV 2.7/1 Rev. 4 and includes a clear State of the Art analysis.

🔍 Notified Bodies are rejecting CERs that rely solely on equivalence without full access to competitor data.

5. Implement a Robust Post-Market Surveillance (PMS) System

MDR doesn’t end at certification — it requires ongoing vigilance. You must have:

• A PMS Plan (Annex III)
• Periodic Safety Update Reports (PSURs) for Class IIa and above
• A system to collect and analyze real-world data

🔄 Think of PMS as your living safety net — it feeds back into risk management and clinical evaluation.

6. Prepare for Notified Body Audit (If Applicable)

Class I devices (non-sterile, non-measuring) self-certify, but Class IIa and above require a Notified Body. Given long waiting times and high rejection rates, engage your NB early and ensure your Quality Management System (QMS) aligns with MDR and ISO 13485.

⏳ Tip: Schedule your audit only when your technical file is 95% complete — incomplete submissions waste precious time.

7. Register in EUDAMED and Implement UDI

While EUDAMED is being rolled out in phases, UDI assignment and labeling are already mandatory. Ensure your devices carry compliant UDI carriers (barcode/RFID), and prepare to upload data to the database once your actor ID is assigned.

🌐 UDI isn’t just a label — it’s the backbone of traceability, recall management, and market surveillance.

Compliance Is Just the Beginning

Achieving MDR compliance opens the door to the EU market — but commercial success requires more. At MHP, we combine deep regulatory expertise with practical market access support, helping you not only meet the rules but also build a sustainable presence in Europe.

Need help navigating your MDR journey?
From gap assessments to EU representation and commercial rollout — we’ve got you covered.

Stay compliant. Stay competitive. Stay ahead.
— The MHP Team