Supporting the increased capacity and
competence building of the EU medicines regulatory network

Innovative Technology Impact Assessment

IncreaseNET – Task 8.6 | Grid of criteria

0 of 14 scored questions completed

Purpose of the tool

This tool supports a systematic assessment of the potential impact of an innovative technology on the organisation and regulatory activities of a National Competent Authority (NCA). It is intended to help identify areas where preparedness may need to be strengthened and to support internal reflection and discussion.

How to use it: identify the technology, select the relevant product categories and regulatory domains, then score each assessment question from 1 to 5. Optional free-text fields can be used to document case-specific considerations. The guidance box at the end of each section highlights aspects that may help strengthen preparedness.
Standalone version: entries are kept only while this page is open, are cleared when the tool is closed, and are not transmitted to an external service.

Medicinal products

Medical device (MD) / IVD

Combined product

Medicines – Quality

Medicines – Non-clinical

Medicines – Clinical

Medicines – Other medicines categories

Medicines – Vigilance

Medicines – Inspection

Medicines – Lab control

MD/IVDs

MD/IVDs – Inspection

MD/IVDs – Lab control

Q1 – Knowledge & experience
How would you assess your NCA’s current knowledge and experience with this technology or similar technologies?
1 – Very limited
5 – Extensive
Q2 – Competencies & impact assessment
How confident are you that your NCA has the competencies needed to understand the technology and assess its impact on regulatory activities?
1 – Not confident
5 – Fully confident
Q3 – Ability to address knowledge gaps
How prepared is your NCA to address identified knowledge or competency gaps through available resources, training or knowledge-sharing?
1 – Not prepared
5 – Fully prepared

Need to strengthen this area?

Based on your assessment, consider previous similar procedures and Scientific Advice, available internal expertise, scientific and regulatory literature, training opportunities (e.g. EU NTC), and relevant national or EU expert networks. Also consider potential impacts on methodologies, inspection, laboratory control and existing regulatory competencies.

Q1 – Internal capacity
How would you assess your NCA’s current human capacity to address the specific requirements of this technology?
1 – Very insufficient
5 – Fully sufficient
Q2 – Ability to adapt resources
How prepared is your NCA to adapt or mobilise internal resources if additional capacity is needed?
1 – Not prepared
5 – Fully prepared
Q3 – Access to additional expertise
How prepared is your NCA to identify and mobilise additional expertise when the required resources are not available internally?
1 – Not prepared
5 – Fully prepared

Need to strengthen this area?

Consider available internal assessors and expertise, opportunities to reallocate resources or create a dedicated team, and additional expertise available through external experts, other NCAs or EU/international networks.

Q1 – Technical & assessment tools
How would you assess the availability of tools and methods needed to evaluate this technology and challenge the evidence provided by the applicant?
1 – Not available
5 – Fully available
Q2 – Data-related tools
How prepared is your NCA to manage and assess the data associated with this technology using appropriate tools?
1 – Not prepared
5 – Fully prepared
Q3 – Procedural & collaborative tools
How well do existing tools and procedures support the integration of this technology into regulatory activities and cross-functional collaboration?
1 – Not at all
5 – Fully

Need to strengthen this area?

Consider whether existing assessment methods, data tools, procedures and collaborative tools are sufficient to address the technology. Identify where tools or processes may need to be adapted or developed.

Q1 – Applicability of the regulatory framework
How confident are you in identifying and applying the existing regulatory framework and guidelines relevant to this technology?
1 – Not confident
5 – Fully confident
Q2 – Regulatory gaps & adaptation needs
How well can existing regulations and guidelines address the specificities of this technology, including potential gaps or inconsistencies?
1 – Major gaps identified
5 – Fully addressed

Need to strengthen this area?

Identify the closest applicable regulatory framework and relevant guidance. Where gaps or inconsistencies remain, seek internal or EU-level alignment and consider whether existing guidance should be adapted or complemented.

Q1 – Continuity & coordination
How well does your NCA’s current organisation ensure continuous and coordinated support for innovative technologies?
1 – Not at all
5 – Fully
Q2 – Organisational adaptability
How well can your NCA’s current organisation and professional roles adapt to the specific challenges raised by innovative technologies?
1 – Major changes needed
5 – Fully adaptable
Q3 – Openness & interaction model
How well does your NCA’s current model support appropriate interactions with innovators and external expertise?
1 – Major changes needed
5 – Fully adapted

Need to strengthen this area?

Consider whether organisational changes are needed to ensure continuity, cross-functional collaboration and flexible expertise, and whether new interfaces, roles or forms of interaction could better support innovative technologies.

Impact Assessment Report

Structured summary of the information entered and the preparedness scores recorded for this innovative technology.