Step-by-Step Guide to MDR Certification for Medical Devices
Getting MDR certification may feel complex, but breaking it down into steps makes the process more manageable. This guide explains how medical device companies can navigate MDR certification — from classification to CE marking — and successfully enter the EU market.
Why MDR Certification Matters
The EU Medical Device Regulation (MDR 2017/745) sets high standards for safety, quality, and performance. Without MDR certification, manufacturers cannot legally market devices in Europe. Achieving compliance is not just about ticking boxes — it’s about proving that your device is safe, effective, and trustworthy.
Step 1: Determine the Right Regulation
First, confirm whether your product falls under MDR (for medical devices) or IVDR (for in-vitro diagnostics). Misclassification at this stage can delay certification.
Step 2: Classify Your Device
Medical devices are categorized into four classes:
- Class I (low risk)
- Class IIa & IIb (medium risk)
- Class III (high risk)
Higher classes require more stringent evaluations and notified body involvement.
Step 3: Implement a Quality Management System (QMS)
A strong QMS — often based on ISO 13485 — is essential for MDR compliance. It ensures consistency, traceability, and risk management throughout the product lifecycle.
Step 4: Prepare Technical Documentation
Your technical file must include:
- Device description & intended use
- Risk management (ISO 14971 alignment)
- Clinical evaluation reports
- Manufacturing process details
- Labeling and instructions for use
Step 5: Engage a Notified Body
For all but Class I non-sterile devices, a Notified Body must review and approve your documentation. They will perform audits and issue the CE certificate if requirements are met.
Step 6: Register in EUDAMED
The EU requires all devices to be listed in the EUDAMED database, along with a Unique Device Identification (UDI) code for traceability.
Step 7: Affix the CE Mark
Once approved, manufacturers can legally place the CE mark on the device, packaging, and promotional materials, signaling compliance across the EU.
Step 8: Maintain Post-Market Surveillance
MDR certification isn’t a one-time task. Companies must conduct ongoing monitoring, report adverse events, and update documentation regularly.
Practical Tips for Smooth Certification
- Begin preparations early — certification can take 12–24 months.
- Keep communication open with your notified body.
- Train your teams on MDR requirements.
- Use compliance software to track documents and deadlines.
