1. Classify Your Medical Device

Classify your device based on its risk level, duration of use, and invasiveness:

• Class I (low risk)
  
• Class IIa / IIb (medium to high risk)
  
• Class III (high risk)
  

2. Appoint a PRRC (Person Responsible for Regulatory Compliance)

Ensure regulatory oversight by assigning a qualified expert as per EU MDR Article 15.

3. Implement ISO 13485-Compliant QMS

Set up a Quality Management System and Risk Management process aligned with ISO 13485:2016 and ISO 14971.

4. Compile Technical Documentation

Create structured documentation covering:

• Device description
  
• Design & development data
  
• Risk management reports
  
• Post-market surveillance plans
  
• Clinical evaluation report (CER)
  

5. Supplier and Manufacturing Controls

Develop a supplier management system, maintain an Approved Supplier List (ASL), and ensure manufacturing traceability.

6. Perform Clinical Evaluation

Demonstrate device safety and performance using clinical data. Class IIb and III devices may require expert panel consultation.

7. Appoint an EU Authorized Representative (EU AR)

If based outside the EU, designate an Authorized Representative to handle communication with EU authorities.

8. Engage with a Notified Body

For Class IIa, IIb, and III devices, a Notified Body audit is required. They assess your QMS and technical documentation.

9. Issue the EU Declaration of Conformity

After a successful audit, issue the DoC stating conformity with EU MDR or IVDR.

10. Register in EUDAMED & Assign UDI

Register your device and company in EUDAMED, and implement the Unique Device Identifier (UDI) system.

11. Affix the CE Mark

Place the CE mark on the product, labeling, and IFU. Add the four-digit number of the Notified Body (for applicable classes).

12. Establish Post-Market Surveillance

Monitor and analyze performance, collect feedback, and ensure continuous compliance via PMS and vigilance systems.