A notable change in Notified Body technical documentation assessment time.
Software is playing an increasingly important role in modern in-vitro diagnostic medical devices. From software used for analysis and monitoring to software that controls IVD instruments and systems, software functionality can have a significant impact on the performance and safety of an IVD.
Recognising the growing complexity of software-related IVD technologies, TEAM-NB has updated its Code of Conduct for Notified Bodies.
What has changed?
The 2026 update increases the estimated assessment time from +0.5–1 day to +1–3 days for both:
1. Software for analysis, monitoring — IVS1009
This category covers IVDs where software is involved in analysis or monitoring.
Assessment time:
2025 → +0.5–1 day
2026 → +1–3 days
2. Controlled by Software — IVS1010
This category covers IVDs that are controlled by software.
Assessment time:
2025 → +0.5–1 day
2026 → +1–3 days
Why does this matter?
The TEAM-NB framework explains that the assessment-time table is used to estimate the time required for the first round of technical documentation assessment. One assessment day corresponds to 8 hours.
The document also explains that assessment time can increase depending on the technical or clinical complexity of the device. Additional time may also be necessary where technical documentation is low quality, insufficiently structured or not readily searchable.
Therefore, the increase from +0.5–1 day to +1–3 days is an important consideration for manufacturers developing or maintaining software-related IVDs.
What should manufacturers focus on?
For devices falling under these software-related categories, manufacturers should ensure that their technical documentation is:
- Complete and well structured.
- Consistent with the device’s intended purpose
- Supported by appropriate software verification and validation evidence
- Linked appropriately to risk-management documentation
- Clear regarding software functionality and its role in the IVD
- Supported by relevant technical and performance evidence
A well-organised technical documentation package can help facilitate an efficient assessment.
Why has the assessment time increased?
What the document does state is that the assessment-time framework is intended to determine appropriate time for technical documentation review, taking into account the characteristics and complexity of the device.
The document specifically states that assessment time may increase because of:
- Technical or clinical complexity
- Novel medical indications
- Multiple indications
- Multiple analytes
- Need for external experts
- Device grouping
- Low-quality technical documentation
- Poorly structured technical documentation
- Documentation that is not readily searchable
Reference
1. Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746
