How much does a Notified Body certification cost?

The cost of obtaining certification from a Notified Body varies widely depending on multiple factors, including the classification of the medical device, scope of assessment, and specific Notified Body fees.

First and foremost, the figures presented below are only general ballpark estimates — they are derived from market trends and not from any specific Notified Body.

Why exact pricing requires direct inquiry

Notified Body certification costs can vary significantly depending on several factors, including:

• The class and complexity of your medical device.
• The scope of assessment required under MDR or IVDR.
• The specific Notified Body you choose, as different organizations have different fee structures.
• The level of preparedness of your technical and quality documentation.

Contacting a Notified Body for an accurate quote

To receive a precise cost estimate, you must contact a Notified Body directly and request a quote based on your device’s classification, intended use, and documentation status.

Important: Before reaching out to a Notified Body, ensure that your technical documentation and quality management system (QMS) are in place. Notified Bodies require well-prepared submissions to assess compliance efficiently. Without these, you risk unnecessary delays and increased costs due to additional review cycles.

Key cost factors for Notified Body certification

The cost of obtaining Notified Body certification varies significantly depending on several factors. Below are the key elements that influence the total cost:

1. Device classification

Higher-risk devices require more extensive assessments, leading to increased certification costs:

• Class I (with NB involvement) – Minimal cost.
• Class IIa – Moderate cost, requires technical documentation review.
• Class IIb – Higher cost, includes design examination.
• Class III – Most expensive, requires comprehensive audits.

2. Scope of assessment

Certification involves multiple evaluations, including:

• Technical documentation review
• Quality Management System (ISO 13485) audits
• Post-market surveillance requirements
• Product Testing & separate audit of clinical valuation

3. Type of certification required

The costs vary based on the type of certification being sought:

• Initial certification – First-time applicants undergo full audits and reviews.
• Surveillance audits – Annual checks to ensure compliance.
• Certificate renewal – Every 5 years, requires reassessment.

4. Notified Body selection

Different Notified Bodies have varying fee structures.

5. Geographical factors

The location of audits and Notified Bodies can impact costs due to travel, regulatory differences, and administrative fees.

Estimated costs for Notified Body certification

The cost of obtaining certification from a Notified Body varies based on several factors, including the classification of the medical device, the complexity of the assessment, and the Notified Body itself. Below is an estimated breakdown of certification costs.

1. Initial application and review Fees

Medical device manufacturers must submit an application to a Notified Body for assessment. The application and review process typically include:

• Administrative review of documentation.
• Technical file assessment.
• Quality Management System (QMS) evaluation.

Estimated cost: €5,000 – €15,000

2. Conformity assessment fees

Depending on the classification of the device, a full conformity assessment may be required. This typically involves:

• Verification of compliance with MDR/IVDR.
• Product testing and evaluation.
• Clinical data assessment.

Estimated cost: €10,000 – €50,000

3. Audit and on-site inspection costs

For Class IIa, IIb, and III medical devices, Notified Bodies require on-site audits to assess the manufacturer’s Quality Management System (QMS) compliance with ISO 13485 and MDR/IVDR.

Estimated Cost: €15,000 – €40,000 per audit

4. Certification issuance fees

Once all assessments and audits are successfully completed, the Notified Body issues a CE certification allowing market entry.

Estimated cost: €3,000 – €10,000

5. Annual surveillance fees

After certification, manufacturers are required to undergo annual surveillance audits to maintain compliance.

Estimated cost: €10,000 – €30,000 per year