Your Notified Body is the organization that stands between your medical device and the EU market. Choosing the wrong one can add months to your timeline, inflate your costs, or create a frustrating mismatch between your device type and the auditor's expertise. Choosing the right one gives you a smoother path to certification and a productive long-term relationship.

Here is how to make that choice systematically.

How Many Notified Bodies Are Available Under MDR?

As of early 2026, approximately 40 Notified Bodies have been designated under the MDR . This is roughly half the number that operated under the MDD. The reduction is directly caused by the stricter designation requirements in Articles 35–44 of the MDR.

The current list of designated Notified Bodies is maintained in the NANDO database (New Approach Notified and Designated Organisations), accessible on the European Commission's website .

Not every Notified Body covers every device type. Each Notified Body's designation specifies the MDR annexes and the product scope (device types) for which they are authorized to conduct conformity assessments. Before you approach a Notified Body, verify that your device falls within their scope.

What Selection Criteria Should You Use?

1. Scope of Designation

This is the first filter. Check the NANDO database for each Notified Body's scope. If your device is a Class IIa software product, you need a Notified Body designated for software medical devices under the relevant MDR annexes. If your device is a Class III implantable, you need a Notified Body with that specific scope.

Some Notified Bodies have broad scope covering most device categories. Others specialize in specific areas. A Notified Body with deep expertise in your device category will have auditors who understand your technology, which leads to more productive audits and fewer misunderstandings.

2. Capacity and Timeline

Ask directly: what is your current lead time from contract signature to Stage 1 audit? From Stage 1 to Stage 2? What is your typical turnaround time for reviewing corrective actions?

Lead times vary enormously between Notified Bodies — from a few months to well over a year. For a startup with investors expecting market launch, this is not a secondary consideration. It may be the primary decision factor.

Be aware that quoted timelines may be optimistic. Ask for the actual average across recent engagements, not the theoretical best case.

3. Experience with Startups

Some Notified Bodies primarily serve large, established manufacturers. Their processes, expectations, and communication styles are calibrated for companies with 50-person regulatory teams. A startup with three employees and a first-time QMS is a different proposition entirely.

Other Notified Bodies have experience working with smaller companies and early-stage organizations. They understand that a startup's QMS will look different from a multinational's QMS — leaner, more focused, potentially less mature in some areas. This does not mean they lower the bar — the MDR requirements are the same regardless of company size — but they understand the context.

Ask the Notified Body: how many startups or SMEs have you certified in the past two years? Can you provide references?

4. Auditor Expertise

The quality of your audit experience depends heavily on the individual auditors assigned to your project. Auditors with deep technical knowledge of your device type will ask relevant questions, understand your design rationale, and focus on the areas that matter. Auditors without that expertise may focus on generic QMS processes and miss the technical substance — or ask questions that reveal a lack of understanding of your technology.

You generally cannot choose your auditor, but you can ask about the Notified Body's auditor pool for your device category. How many auditors do they have with relevant expertise? What is their background?

Tibor, having worked as a lead auditor himself, emphasizes this point: "The auditor makes or breaks the experience. A knowledgeable auditor is a gift — they find real problems and help you fix them. An uninformed auditor wastes everyone's time on irrelevant issues."

5. Geographic Location

While there is no MDR requirement that your Notified Body be in the same country as your company, practical considerations matter:

  • Audit costs: On-site audits require the auditor to travel to your premises. A Notified Body in another country means higher travel costs and potentially more scheduling complexity.
  • Language: Audits are typically conducted in English, but working with a Notified Body in your language can smooth communication, especially for detailed technical discussions.
  • Time zone and culture: For ongoing communication during the certification process, a Notified Body in a similar time zone and cultural context can reduce friction.

For startups in the DACH region, there are several Notified Bodies based in Germany and Austria that offer convenient access and German-language capability.

6. Cost Structure

Notified Body fees include: - Application fee: One-time fee for processing your application - Audit fees: Charged per audit day, typically EUR 1,200–2,500 per auditor per day - Technical documentation review fees: Charged separately from audit fees - Certificate fees: Annual fee for maintaining the certificate - Surveillance fees: Annual audit fees for ongoing surveillance - Unannounced audit fees: Some Notified Bodies charge separately for unannounced audits

Get detailed quotations from at least two to three Notified Bodies. Compare the total cost of the first certification cycle (application through certificate issuance) and the ongoing annual costs (surveillance audits, certificate maintenance).

Be cautious of Notified Bodies with unusually low fees. Regulatory certification is not a commodity — the cheapest option may reflect less thorough assessments, which can cause problems later when a more rigorous Notified Body or competent authority reviews the same device.

7. Communication and Responsiveness

During the certification process, you will have questions. You will need clarifications. You will submit documents for review. How quickly does the Notified Body respond? Is there a dedicated contact person for your project? Can you reach someone when you need to?

Ask existing clients about their experience with communication. A Notified Body that takes weeks to respond to straightforward questions will extend your timeline and frustrate your team.

How Do You Approach a Notified Body?

Step 1: Prepare your application materials. Most Notified Bodies have a standard application form. You will need to describe your device, its classification, its intended purpose, your quality management system status, and the conformity assessment procedure you intend to follow.

Step 2: Contact multiple Notified Bodies. Do not put all your eggs in one basket. Approach at least three Notified Bodies, submit applications, and compare their responses — timelines, costs, questions asked, and overall professionalism.

Step 3: Conduct a reference check. Ask each Notified Body for references from similar companies (startups, similar device types). Speak to those references about their experience.

Step 4: Negotiate timeline commitments. Where possible, get written commitments on key milestones — when Stage 1 will occur, when Stage 2 will follow, what the expected turnaround time for certificate issuance will be after a successful audit.

Step 5: Sign the contract and start preparing. Once you have selected your Notified Body, sign the contract and begin your audit preparation immediately. The time between contract and audit is your preparation window — use every day of it.

Can You Switch Notified Bodies?

Yes, but it is not trivial. If your current Notified Body is not performing — missing timelines, providing poor communication, assigning inexperienced auditors — you can switch. The new Notified Body will need to review your previous assessment history and may require a full re-assessment.

Switching mid-certification (before your first certificate is issued) is more disruptive than switching during surveillance (after you already have a certificate). The new Notified Body must conduct their own assessment from scratch in most cases.

The best approach is to choose well the first time and avoid switching. But if the relationship is genuinely dysfunctional, switching is better than staying with a Notified Body that is not serving your needs.

The Bottom Line

Your Notified Body is a long-term partner. Certificates last up to five years, with annual surveillance. You will work with this organization for years. Choose based on competence, timeline, communication quality, and relevant expertise — not just cost.

Start the selection process early. The earlier you engage, the more options you have and the sooner you enter the audit queue. Waiting until your documentation is "perfect" before approaching a Notified Body is a common startup mistake — you can prepare in parallel with the queue time.

Next: The Notified Body Bottleneck: Strategies for Startups Facing Long Wait Times.