TEAM-NB Updates Code of Conduct for Notified Bodies (Version 5.2 – April 2026)

TEAM-NB has released Version 5.2 of its Code of Conduct (CoC) for Notified Bodies operating under the EU MDR (2017/745) and IVDR (2017/746), reinforcing efforts to harmonise conformity assessment practices across Europe.

While the Code remains voluntary, it sets clear expectations for participating Notified Bodies (NBs) and introduces refinements that are likely to directly impact manufacturers’ certification timelines, audit experience, and documentation requirements.

Key Updates at a Glance

1. Stronger alignment with MDR/IVDR and removal of legacy references

• All references to previous Directives (MDD, AIMDD, IVDD) have been removed

• Updated links to MDCG guidance, IAF documents, and current regulatory frameworks

• Reinforces alignment with Annex VII requirements for Notified Bodies

Impact for manufacturers:

Expect greater consistency between Notified Bodies, but also less flexibility where interpretations previously varied.

2. More structured approach to audit duration and resource planning

The CoC introduces a detailed methodology for determining audit time, based on:

• Number of employees (FTE)

• Device complexity and classification

• Manufacturing processes and technologies

• Regulatory history and compliance performance

It also defines clear adjustment factors, for example:

• +10% or more for high-risk devices, multiple regulations, or complex processes

• Reductions (up to -20%) for mature QMS or low-risk activities

Impact for manufacturers:

• More predictable—but potentially longer—audits

• Higher scrutiny for complex portfolios (e.g., software, Class III, IVD Class D)

• Limited opportunity to reduce audit time without strong justification

3. Increased transparency in Technical Documentation (TD) assessment timelines

For the first time, the CoC provides indicative review timelines:

• Typical TD assessments: 4–8 days, depending on device type

• Additional time for:

  • Software (+1–3 days)

  • Biological or medicinal components (+2–3 days)

  • Complex or poorly structured documentation

Impact for manufacturers:

• Quality and structure of Technical Documentation directly affect review time

• Poorly prepared files may lead to delays and increased costs

• Better planning is required for submission timelines

4. Reinforced expectations for unannounced audits

The CoC confirms:

• At least one unannounced audit every 5 years

• Increased frequency for:

  • High-risk devices

  • High complaint or non-conformity rates

• Audits may extend to suppliers and subcontractors

Impact for manufacturers:

• Need for continuous audit readiness across the entire supply chain

• Contracts must allow NB access to critical suppliers

• Greater emphasis on traceability and batch-level documentation

5. Clearer rules for recertification and lifecycle oversight

The CoC strengthens expectations during renewal, requiring review of:

• Post-market surveillance (PMS) and PSURs

• Clinical evaluation updates and PMCF

• Risk management and GSPR compliance

• Changes in standards, regulations, and scientific knowledge

Impact for manufacturers:

• Recertification becomes a holistic lifecycle review, not just a formality

• Increased importance of continuous clinical and PMS activities

6. Defined timelines for corrective actions

The CoC harmonises timelines:

• 30 days to submit CAPA

• Up to 90 days (max 3 attempts) for acceptance

• Up to 365 days for implementation (depending on scope)

Impact for manufacturers:

• Less flexibility in responding to non-conformities

• Stronger need for robust CAPA processes and internal coordination

7. Clarification of structured dialogue boundaries

NBs may support discussions on:

• Project planning

• Submission requirements

• Timelines and expectations

However, they cannot:

• Perform gap analyses

• Provide regulatory consulting

• Review draft documentation

Impact for manufacturers:

• Greater reliance on internal expertise or external consultants

• Reduced expectation of “informal guidance” from NBs

Final Thoughts

The updated TEAM-NB Code of Conduct reflects a continued push toward harmonisation, transparency, and consistency in the EU regulatory system.

For manufacturers, this translates into:

• More predictable—but stricter—conformity assessment processes

• Increased importance of high-quality documentation and lifecycle data

• Greater need for strategic planning of audits, submissions, and supplier oversight

Read the full document below.