Team-NB
Team-NB is the European trade association representing 44 EU Notified Bodies for medical devices and IVDs, providing harmonized regulatory guidance, training programs, and stakeholder representation under MDR and IVDR frameworks.
- Company typePrivate
- Founded2001
- HeadquartersSprimont, Belgium
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Team-NB does
Team-NB is the European Association of Notified Bodies for Medical Devices and In Vitro Diagnostics, founded in 2001 and headquartered in Brussels, Belgium. It coordinates 44 EU-designated Notified Bodies that conduct conformity assessments under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), and membership had expanded to 55 members by the February 2026 member list. The association does not develop proprietary technology products; instead, its core deliverables are harmonized Best Practice Guides, a Code of Conduct (Version 5.2 adopted by unanimous member vote in April 2026), position papers, and stakeholder representation before the European Commission, European Parliament, and other EU bodies. Major members include BSI, DEKRA (B.V. and GmbH), GMED, NSAI, TÜV Rheinland LGA, and TÜV SÜD.
Its product portfolio comprises full-day virtual training programs for manufacturers — IVDR Technical Documentation Training (€600 SMEs / €1,200 organizations), MDR Technical Documentation Training (€495 SMEs / €990 organizations), and MDR Clinical Training (€275 SMEs, expanded from half-day to full-day in May 2026) — plus an annual EU Regulations Discussion Day (€250-€500 per attendee), an Annual Sector Survey, and a private member document repository. Content for training programs is co-developed by technical experts from multiple member notified bodies, creating a multi-stakeholder validation effect.
Revenue is generated through two channels: recurring membership subscription fees from the notified body members and unit-priced training and event fees differentiated by participant category (SME vs. organization) and early-bird vs. standard pricing. GTM is event-driven and consultation-driven, anchored on the regulatory revision cycle: the organization engages manufacturers through training, industry events, stakeholder consultations, and the annual Discussion Day forum. Leadership comprises Director Françoise Schlemmer and Vice President Sabina Hoekstra-van den Bosch, supported by a small staff of 1-10 employees.
Team-NB firmographics
Firmographics- Name
- Team-NB
- Legal name
- Team-NB
- Website
- https://team-nb.org
- Company type
- Private
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Team-NB is the European trade association representing 44 EU Notified Bodies for medical devices and IVDs, providing harmonized regulatory guidance, training programs, and stakeholder representation under MDR and IVDR frameworks.
- Ownership category
- akta.pro rank
Where Team-NB is headquartered
LocationHeadquarters
- HQ city
- Sprimont
- HQ country
- Belgium
- HQ region
- Europe
Offices1 record
Markets served
Team-NB business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D
Revenue model
- Training Services: Team-NB generates revenue through training programs for medical device and IVD manufacturers, including IVDR Technical Documentation Training (€600 for SMEs, €1200 for organizations), MDR Technical Documentation Training (€495 for SMEs), and MDR Clinical Training (€275 for SMEs). Additional training programs cover PMS, software, and substance-based devices.
- Membership Fees: Team-NB represents 44 member notified bodies, suggesting membership-based revenue to support the association's operations and activities.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | One time | IVDR Technical Documentation Training - SME Rate |
| Unit Pricing | One time | IVDR Technical Documentation Training - Organization Rate |
| Unit Pricing | One time | MDR Technical Documentation Training - SME Rate |
| Unit Pricing | One time | MDR Clinical Training - SME Rate |
| Unit Pricing | One time | 2nd EU Regulations Discussion Day 2026 - SME/Early Bird |
| Unit Pricing | One time | 2nd EU Regulations Discussion Day 2026 - Organization/Early Bird |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels6 records
Team-NB product offering
Product offeringCore offering
Team-NB is the European Association of Notified Bodies for Medical Devices and IVDs, representing 44 designated EU Notified Bodies. It delivers paid training programs on MDR/IVDR technical documentation and clinical evaluation, publishes harmonized Best Practice Guides and Position Papers, maintains a Code of Conduct, and conducts the Annual Sector Survey and EU Regulations Discussion Day to support consistent conformity assessment across Europe.
Product overview
Team-NB is the European association of Notified Bodies for medical devices, offering a portfolio of training programs, regulatory guidance documents, and industry events rather than a traditional software product. The core offerings include: IVDR and MDR Technical Documentation Training for Manufacturers (collaboratively developed by experts from 7 notified bodies), MDR Clinical Training for Manufacturers, Position Papers providing harmonized notified bodies' expectations on regulatory matters, a Code of Conduct (Version 5.2) adopted by member unanimity, Annual Sector Surveys providing market intelligence, and the EU Regulations Discussion Day conference. All offerings support notified bodies and manufacturers in complying with EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The association also maintains private member resources including templates and working group documents.
Differentiator
Problem solved
Functional benefit
Products and services
- IVDR Technical Documentation Training Paid training program equipping IVD manufacturers and regulatory professionals with the requirements for compiling and reviewing technical documentation under the EU IVDR. Offered at tiered rates for SMEs and standard organizations.
- MDR Technical Documentation Training Paid training program equipping medical device manufacturers and regulatory professionals with the requirements for compiling and reviewing technical documentation under the EU MDR. Offered at tiered rates for SMEs and standard organizations.
- MDR Clinical Training Paid training program covering clinical evaluation, clinical investigation, and related requirements under the EU MDR for medical device manufacturers and regulatory professionals.
- Annual Sector Survey Annual published survey reporting member Notified Body activity, certification volumes, and sectoral data, providing the most comprehensive published dataset on EU Notified Body operations.
- EU Regulations Discussion Day Annual conference organized by Team-NB for members, manufacturers, and regulators to discuss developments in EU MDR/IVDR and conformity assessment practice.
- Code of Conduct Governance document establishing operational, ethical, and professional standards to which member Notified Bodies commit, supporting harmonized practice across the EU.
Quantifiable outcome
- 104 persons from Team-NB members worked on MDR/IVDR revision feedback comments
- +1 more outcomes
Companies that use Team-NB
Customer profileSegments3 records
Ideal customer profiles3 records
Team-NB technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Team-NB partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core and minor.
- BSI, Dekra B.V., Dekra GmbH, GMED, NSAI, TÜV Rheinland LGA, TÜV SÜDcoreIVDR Technical Documentation training content was elaborated by IVD experts from 7 notified bodies including BSI, Dekra B.V., Dekra GmbH, GMED, NSAI, TÜV Rheinland LGA and TÜV SÜD. These member organizations collaborate on developing harmonized training materials.
- ESMINT (European Society of Minimally Invasive Neurological Therapy)minorTeam-NB experts contributed to the ESMINT-led European Multisociety Consensus paper defining clinical evidence standards for high-risk endovascular stroke devices. Team-NB participated in stakeholder discussions for this consensus.
- European Social Insurance Platform (ESIP)coreCo-signed joint stakeholder statement with ESIP, AIM, CPME, TÜV Verband and IG-NB highlighting shared concerns regarding the Commission's Delegated Regulations on well established technologies (WET) and calling for further refinement to ensure legal certainty and consistent application under MDR.
- Standing Committee of European Doctors (CPME)coreCo-signed joint stakeholder statement on WET regulations under MDR with CPME and other healthcare stakeholders.
- TÜV VerbandcoreCo-signed joint stakeholder statement with TÜV Verband and other organizations on MDR well established technologies regulations.
- Interest Group of Notified Bodies (IG-NB)coreCo-signed joint stakeholder statement with IG-NB on MDR/IVDR regulatory matters, particularly regarding WET regulations and consistent application under MDR.
- Association of Mutual Benefit Societies (AIM)coreCo-signed joint stakeholder statement with AIM representing healthcare insurers on MDR WET regulations.
- MedTechLabel EU ProjectcoreTeam-NB is an official partner of the MedTechLabel EU project, a European initiative aiming to develop a unified digital labelling framework for medical technology products (MD/IVD).
Scale indicators2 records
Recent moves6 records
Expansion highlights5 records
Team-NB competitors and assessment
Company assessmentBroad incumbents
- AdvaMed: Leading US medical technology industry association. Comparable in mission (industry coordination, regulatory advocacy, training) though US-focused; a useful benchmark for association scale and policy influence.
- MedTech Europe: Largest European trade association representing the medical technology industry (including IVD). Comparable as the broader industry-association counterpart to Team-NB's notified-body focus, with overlapping MDR/IVDR policy advocacy.
Direct peers
- NB-MED: European coordination forum for medical device Notified Bodies, historically issuing consensus recommendations on MDR/IVDR technical documentation. Closely comparable in mission and member base to Team-NB.
- IG-NB (Interest Group of Notified Bodies): German-based coordination body for Notified Bodies, with overlapping scope on MDR/IVDR harmonization and a co-stakeholder relationship with Team-NB (joint WET statement). Directly comparable as a peer association of EU notified bodies.
Regional players
- COCIR: European trade association for the medical imaging, radiotherapy, and digital health industries. Comparable as a specialized European medical-technology sector association engaging with EU regulatory bodies.
- NBOG (Notified Body Operations Group): European Commission-advisory group coordinating operational practices across all EU Notified Bodies (not just MD/IVD). Comparable as a sector-coordination peer operating at EU regulatory interface.
Emerging players
- RAPS (Regulatory Affairs Professionals Society): Global professional society for healthcare regulatory professionals, offering regulatory training, certifications, and publications. Comparable as a peer organization delivering training and thought leadership on MDR/IVDR-adjacent topics.
Others
- European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR): Already listed; overlaps with broader medtech industry advocacy relevant to Team-NB's MDR/IVDR stakeholder ecosystem.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Team-NB social profiles
Digital presenceTeam-NB financial estimates
Financial estimateRevenue estimate
Valuation estimate
Team-NB leadership team
Management profileNumber of profiles
Profiles2 records
Team-NB funding detail
Funding detailFunding overview
Funding rounds
Investors
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Team-NB M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Team-NB
What does Team-NB do?
Team-NB is the European Association of Notified Bodies for Medical Devices and IVDs, representing 44 designated EU Notified Bodies. It delivers paid training programs on MDR/IVDR technical documentation and clinical evaluation, publishes harmonized Best Practice Guides and Position Papers, maintains a Code of Conduct, and conducts the Annual Sector Survey and EU Regulations Discussion Day to support consistent conformity assessment across Europe.
Is Team-NB a public or private company?
Team-NB is a private company. It is classified as nonprofit foundation owned and is currently operating.
When was Team-NB founded?
Team-NB was founded in 2001. It employs 1 to 10 people.
Where is Team-NB based?
Team-NB is headquartered in Sprimont, Belgium, in the Europe region.
How does Team-NB make money?
Two revenue lines are on record. Training Services are the primary driver. The others are membership Fees.
Who are Team-NB's main competitors?
Broad incumbents on record are AdvaMed and MedTech Europe. Direct peers are NB-MED and IG-NB (Interest Group of Notified Bodies). Regional players are COCIR and NBOG (Notified Body Operations Group). RAPS (Regulatory Affairs Professionals Society) is listed as an emerging player. European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) is listed as an others.
Does Team-NB have an API?
No public API is recorded for Team-NB.