EMA Regulatory
How to Select a Notified Body Under EU MDR: The 5-Step Selection Guide
Quick Answer
Selecting a Notified Body under EU MDR requires five key steps: (1) verify designation in NANDO database, (2) confirm scope covers your device codes, (3) assess capacity and realistic timelines, (4) consider geographic location for audits, and (5) evaluate relevant product experience. Choose based on fit, not just availability.
The email arrives at 4:47 PM on a Thursday.
"Unfortunately, our current capacity does not allow us to take on new MDR applications until Q3 2027."
His third rejection this month.
BSI—18-month waitlist. TÜV SÜD—not designated for his device code. And now this.
Here's what most teams miss:
MDR created a capacity crunch that turned NB selection into a bottleneck no one saw coming.
That bottleneck doesn't just delay one product.
It can freeze an entire portfolio's EU market access while competitors who planned ahead capture market share.
This pattern plays out daily across regulatory teams.
The difference between those who navigate it successfully and those who don't?
A systematic approach to finding the right NB—not just any NB that will take you.
Why Notified Body Selection Matters
Under the MDR, Notified Bodies have significantly expanded responsibilities compared to the Medical Device Directives. They're not just rubber-stamping your technical file—they're actively assessing your clinical evidence, auditing your QMS, and conducting unannounced audits.
Why This Matters: The NB you choose becomes a long-term partner in your regulatory compliance. A poor fit leads to:
- Extended review timelines and repeated deficiency letters
- Auditors unfamiliar with your technology asking irrelevant questions
- Communication gaps due to language or time zone differences
- Capacity constraints forcing you to change NBs mid-certification
Step 1: Check the NANDO Database
The first non-negotiable step is verifying that the Notified Body is actually designated under the MDR.
What is NANDO?
NANDO (New Approach Notified and Designated Organisations) is the European Commission's official database of conformity assessment bodies. For medical devices:
- • MDR Notified Bodies: Search under Directive 34 (Regulation 2017/745)
- • IVDR Notified Bodies: Search under Directive 35 (Regulation 2017/746)
Access NANDO at: ec.europa.eu/growth/tools-databases/nando
Critical Warning
A Notified Body designated under the old Medical Device Directives (MDD/AIMDD) is NOT automatically designated under MDR. Many NBs that operated under MDD did not achieve MDR designation. Always verify MDR-specific designation in NANDO.
Step 2: Verify Device Scope
Why This Matters: Being designated under MDR doesn't mean an NB can certify any device. Their designation specifies which product codes and conformity assessment activities they're authorized to perform.
Each Notified Body's scope is defined using MDR/IVDR device codes. These codes specify:
Product Codes
Codes that define the types of devices the NB can assess (e.g., active implantables, in vitro diagnostics, software as medical device).
Conformity Assessment Procedures
Which annexes of MDR the NB is authorized to assess against (Annex IX, X, XI).
Scope Verification Checklist
- NB is designated under MDR (Regulation 2017/745)
- NB scope includes your device's product code(s)
- NB is authorized for your required conformity assessment route
- No limitations or conditions restrict your device type
- Scope covers all devices in your portfolio (if seeking single NB)
Scope Limitations
As noted in MDCG 2019-14, designating authorities may apply conditions to an NB's designation when the NB doesn't have sufficient competence to cover the entire spectrum of devices within a code. Always check for scope limitations in the NANDO listing.
Step 3: Assess Capacity and Timeline
NB capacity has been one of the most significant challenges in MDR implementation. The MDCG has repeatedly called for transparency around NB capacity.
From MDCG 2022-11 Rev.1
"The MDCG calls on notified bodies to increase transparency around their capacity and timelines for conformity assessment and specifically to make publicly available, ideally on a common website, specific information on capacity available at each notified body across the EU for both MDR and IVDR."
Capacity Assessment Questions
- 1
Initial Response
How quickly does the NB respond to your inquiry? Slow responses often indicate capacity issues.
- 2
Quote Timeline
What's their estimated timeline from contract signing to certificate issuance?
- 3
Audit Availability
When is their next available audit slot? Are they booking 6+ months out?
- 4
Resource Allocation
Will you have a dedicated project manager and consistent review team?
- 5
Backlog Status
What's their current application backlog? Ask directly.
Realistic expectations: As of 2026, most MDR-designated NBs have significant backlogs. Plan for 12-24 months from application to certificate for Class IIb/III devices, depending on complexity.
Step 4: Consider Geographic Location
While EU Notified Bodies can certify manufacturers anywhere in the world, location matters for practical reasons.
Advantages of Local NB
- • Easier coordination of on-site audits
- • Same time zone for communication
- • Shared language (often)
- • Lower travel costs for audits
- • Familiarity with local market context
When Distance Doesn't Matter
- • Remote audits are increasingly accepted
- • Specialized expertise trumps proximity
- • Multi-site manufacturers already coordinate globally
- • Document reviews are location-independent
Key consideration: Under MDR Article 44, NB audits must include on-site assessments at manufacturer premises. Factor audit logistics into your selection.
Step 5: Evaluate Relevant Experience
Why This Matters: An NB that has certified similar devices will ask better questions, identify real risks, and complete reviews more efficiently.
Experience Evaluation Criteria
- Experience with your device type (active, implantable, software, IVD)
- Experience with your clinical area (cardiology, orthopedics, diabetes, etc.)
- Track record with similar manufacturers (company size, development stage)
- Technical reviewer expertise in your technology
- References from manufacturers with similar products
Questions to Ask
- • "How many devices similar to ours have you certified under MDR?"
- • "Who would be assigned as our primary technical reviewer?"
- • "Can you provide references from manufacturers in our space?"
- • "What's your experience with [specific technology/clinical area]?"
Understanding NB Designation Requirements
Understanding how Notified Bodies are designated helps you evaluate their quality and stability.
| Requirement | MDR Reference | What It Means |
|---|---|---|
| Initial Designation | Article 38-39 | Joint assessment by designating authority and assessment team including Commission and other Member States |
| Annex VII Requirements | Annex VII | Organizational, independence, confidentiality, liability, quality management, and personnel requirements |
| Re-assessment | Article 44(10) | Complete re-assessment every four years to verify continued compliance |
| Ongoing Surveillance | Article 44 | Continuous monitoring by designating authority including unannounced audits |
Re-Assessment Timeline
Per MDR Article 44(10), every four years after notification, a complete re-assessment determines whether the NB still satisfies Annex VII requirements. This is conducted by the designating authority with a joint assessment team appointed under Articles 38-39.
Changing Your Notified Body
Sometimes you need to change NBs—whether due to capacity constraints, scope changes, or relationship issues.
NB Change Process
- 1
Confirm Capacity
Verify the new NB has available capacity and appropriate scope before initiating change.
- 2
Documentation Transfer
Ensure the new NB can access all relevant technical documentation and QMS records.
- 3
Legacy Device Considerations
Update documentation confirming legacy device status if applicable (see MDCG Q&A Rev.2).
- 4
Certificate Continuity
Plan the transition to avoid gaps in certification coverage.
- 5
Notify Outgoing NB
Formally notify your current NB of the planned change per contractual requirements.
From MDCG Q&A Rev.2
When changing NBs, manufacturers should confirm available capacity at the incoming NB—especially important when the outgoing NB has capacity constraints or when the incoming NB is newly designated under MDR.
Practical Selection Tips
Start Early
Begin NB selection 12-18 months before you need certification. The best NBs have waiting lists. Starting early gives you leverage to negotiate timelines and choose based on fit rather than desperation.
Request Multiple Quotes
Approach 3-5 NBs simultaneously. Compare not just price, but timeline, communication quality, and technical reviewer expertise. The cheapest option rarely delivers the fastest or best service.
Consider Your Full Portfolio
If you have multiple devices, consider whether one NB can cover your entire portfolio. This simplifies audit coordination and builds deeper relationships.
Build the Relationship
Your NB relationship extends for the life of your certificate (up to 5 years). Invest time in understanding their processes, expectations, and preferred communication styles.
References
- 1. Regulation (EU) 2017/745 on medical devices (MDR), Articles 38-44, Annex VII
- 2. MDCG 2019-6: Questions & Answers for Notified Bodies
- 3. MDCG 2019-14: Guidance on Device Codes
- 4. MDCG 2022-11 Rev.1: Notified Body Capacity
- 5. MDCG 2022-14: Transition to the MDR and IVDR - NB Capacity and Device Availability
- 6. MDCG Q&A Rev.2: Transitional Provisions Questions & Answers
Need faster answers? Our AI regulatory assistant delivers instant guidance on Notified Body requirements.
FAQ
How do I know if a Notified Body is designated for my device type?
How often are Notified Bodies re-assessed?
Can I change my Notified Body mid-certification?
What if there's no Notified Body designated for my device type?
Get Notified Body Requirements Instantly
Notified Body selection involves complex requirements across multiple MDCG documents. Get authoritative answers in seconds.
Stop searching through hundreds of PDFs. Get authoritative answers in seconds.
Test Your Regulatory Knowledge →5 questions · Personalized insights · Free