(一) Main Process of Medical Device CE Registration (According to MDR Regulations)

1.Determine the classification of medical devices

Classified by risk into Class I, Class IIa, Class IIb, and Class III (with Class I being the lowest risk and Class III the highest).

2.Choose a compliant path

IIa/IIb/III categories require review by a notified body (NB), with larger notified bodies such as TUV and BSI; Part of Class I can self declare, and the process is much simpler.

3. Establish a Quality Management System (QMS)

Compliant with ISO 13485 standard, covering production, testing, traceability and other processes.

4. Prepare technical documentation

Include product description, design documents, risk analysis (ISO 14971), clinical evaluation report (CER), labels, instructions, etc., and submit them to the notified body for review.

5. Designate an EU authorized representative

6. Submit conformity assessment

Apply for review from NB, including document review and on-site factory inspection.

7.Obtain CE certificate

After passing the NB audit, a CE certificate will be issued and it can be sold in the EU market.

8. Product registration

Register product and manufacturer information in the EU database (EUDAMED).

（二） Main costs for CE registration of medical devices

1.Inspection fees

According to product complexity: cost of active equipment (such as software and devices)>cost of passive equipment (such as gauze)

Example: Active medical devices require testing for IEC 60601-1 (general standard) and IEC-60601-1-2 (electromagnetic compatibility), with a cost of approximately 60000 to 100000 yuan and a cycle of 4 months to 1 year;

Testing the specialized standards applicable to the product, usually ranging from tens of thousands to tens of thousands of yuan per standard depending on the difficulty level;

Biological testing: For materials that come into contact with the human body, some require biological testing, which requires the selection of CNAS qualified testing institutions on the market. The cost of routine biological testing is approximately 20000 to 50000 yuan, with a cycle of 3 months to 6 months.

2. Announcement Body (NB) audit fee

The cost of this item varies greatly depending on the notified body and product

First certification fee: 80000 to 250000 for Class IIa; Class IIb 150000 to 400000; Class III: 250000 to 600000 yuan;

Annual supervision and audit fee: 40000 to 120000 for Class IIa; Class IIb: 80000 to 200000 yuan; Class III costs 120000 to 300000 yuan.

Note: The cost of active medical devices (such as ventilators) will increase by 30% -50%.

3. Quality Management System (QMS)

ISO13485 certification: 60000 to 200000 (first-time);

Consultation fee for system construction: If the registered system personnel have the ability, they can choose to build the system themselves; Alternatively, you can choose a consulting firm for guidance, which typically costs over 50000 yuan;

Annual maintenance fee: 30000 to 100000 yuan per year.

4. Authorized representative of the European Union

5000 yuan to tens of thousands of yuan per year.

（3） Precautions for successful CE certification

The average cycle of MDR CE certification is 2-3 years. Companies can save a lot of costs and time by choosing experienced registered personnel or consulting firms, which greatly increases the chances of success.