Guiding notes to use the TRL self-

assessment tool

BRIDGE2HE H2020-101005071

Authors APRE, CDTI

Version FINAL

BRIDGE2HE project has received funding from the European Union’s Horizon 2020 research and innovation
programme under Grant Agreement number 101005071
1 INTRODUCTION ................................ ................................ ............................ 3

2 WHAT IS THE TECHNOLOGY READINESS LEVEL SCALE. ................................ ............... 4

3 HOW TO USE THIS TRL SELF-ASSESSMENT TOOL................................. ..................... 7

4 THE TRL SELF-ASSESSMENT TOOL: MAIN ELEMENTS. ................................ ................ 8

Publication Information:

This deliverable was produced under the framework of BRIDGE2HE. The project prime objective is to act as a bridge for NCPs and
participants between H2020 and Horizon Europe. For questions regarding this report please conta ct us at: [email protected]

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1 INTRODUCTION
This document defines the main elements of the TRL self-assessment tool developed under
BRIDGE2HE and states how to use this tool properly. It gives some background information on the
TRL scale and propose three driving questions to guide the users through the tool.

The tool together with this user’s guide can be found under the Horizon Europe NCP Portal at:

https://horizoneuropencpportal.eu/store/trl-assessment

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2 WHAT IS THE TECHNOLOGY READINESS LEVEL SCALE.
The Technology Readiness Level (TRL) scale was introduced into the EU funded projects arena back
in 2014 as part of the Horizon 2020 framework program. The TRL scale was originally defined by
NASA in the 1990’s as a mean for measuring or indicating the maturity of a given technology, from
a paper sketch to its entry into the market.

Typically, new technologies go through the various stages of the TRL scale in their life cycle. During
the research and development phases, it is possible to have iterations among the different TRL levels.
In this sense, the TRL scale also helps to evaluate the project progress.

Figure 1 – Availability of resources for new product development at various TRLs. The gap in the middle is sometimes
referred to as “The Valley of Death” (REHVA Journal 52, 58-62)

When a technology is at TRL 1, scientific research has just started, and the first results are used to be
translated into future research and development. At TRL 2 basic principles have been studied and
first experiments/tests are designed based on the initial findings. TRL 2 technology is still very
speculative. When results from experiments/tests supports the initial idea, the technology is
considered to be at TRL 3. Generally, both analytical and laboratory studies are required at this level
to see if a technology is ready to go to the development phases. At TRL 3, a proof -of-concept model
is constructed. Reaching to this point, one can conclude that the new technology is feasible from a
scientific point of view.

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At TRL 4, the validation of the technology has been performed at the laboratory level, testing each
component so at this point a laboratory prototype is available. TRL 5 is a continuation of TRL 4, but
the testing environment become as closer as possible to a realistic one, although still the environment
is under a control mode. Reaching to this point, one can conclude that the new technology is feasible
from a technological point of view.

In TRL 6, the prototype has to be demonstrated in a real environment, so to confirm the engineering
is feasible. At TRL 7 the technology requires that the working model or the prototype developed to
be demonstrated in an operational environment, typically under industrial conditions and timings.
Reaching to this point, one can conclude that the new technology is reliable from the technological
point of view.

In TRL 8 technology is ready for implementation into an already existing technology or technology
system. Once the technology system has been proven during operations, it can be called TRL 9 and
considered a commercial technology.

Horizon Europe uses the TRL scale as an indicator to position proposals and projects in the program.
The TRL scale for Horizon Europe is defined in the general annexes and set that:

“Where the specific call conditions require a Technology Readiness Level (TRL), the following
definitions apply, unless otherwise specified:

• TRL 1 — Basic principles observed

• TRL 2 — Technology concept formulated

• TRL 3 — Experimental proof of concept

• TRL 4 — Technology validated in a lab

• TRL 5 — Technology validated in a relevant environment (industrially relevant environment

in the case of key enabling technologies)

• TRL 6 — Technology demonstrated in a relevant environment (industrially relevant

environment in the case of key enabling technologies)

• TRL 7 — System prototype demonstration in an operational environment

• TRL 8 — System complete and qualified

• TRL 9 — Actual system proven in an operational environment (competitive manufacturing in

the case of key enabling technologies, or in space)

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In that sense, the TRL enables applicants and reviewers to align with the expectations of the EC in
the context of a Call for Proposals and the different HE instruments, which can be positioned across
the whole scale. The most relevant ones are the following:

• Horizon Europe Research and Innovation actions (RIA & IAs)

The Research and Innovation Actions cover typically projects starting at TRL 2 -3 and reaching TRL
5-6 while the Innovation Actions are covering projects that start at TRL4-5 and end at TRL6-8.

• European Research Council actions (ERC)

The European Research Council actions are typically targeting blue sky research so, in this context,
it is not relevant the entry point (TRL 1 or 2) but only the expected output if able to test ideas that
may lay the foundations for a future technology to be developed. If this is the case one of its main
instruments, the ERC Proof-of-Concept allows project to reach a proof of concept of the technology
at a TRL 3 or 4 level.

• European Innovation Council instruments (EIC)

Due to the nature of the EIC, the use of the TRL scale is very relevant to its main three instruments:

o The EIC Pathfinder program aims to fund project from TRL 1-2 to reach TRL 3-4.

o The EIC Transition program aims to fund projects from TRL 3-4 to reach TRL 5-6.

o The EIC Accelerator program aims to fund companies to move from TRL 5 to TRL9.

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3 HOW TO USE THIS TRL SELF-ASSESSMENT TOOL.
Since the TRL of the project is self-declared, it is important for you to know how the TRL definition
and scale is applied within your sector, especially because the transition between TRL levels can be
a bit elusive if just applying the general Annex definition. As the process of assigning TRL to a project
is not an easy task, especially because it is not consistent across different disciplines, BRIDGE2HE
has developed an expanded TRL matrix to offer applicant a support to correctly define the TRL
according to basically three questions.

1. What is the type of solutions to be developed by the project? This is a very close question with
5 possible types of outputs from a project. The response to this question will determine the row
of the matrix you have to enter. If you have more than one project output, you may need to conduct
your TRL assessment to each of it.

• A product that is manufactured • A medical device

• An industrial process • A drug

• A software

2. What is missing from your innovation to be in its final form? This question assesses the
robustness and completeness of the innovation status. Use this question to navigate in the row
selected in Question 1. If the project is in a scenario with the main features of the innovation in
place, then this is still a prototype (TRL 4 or 5). Conversely if they already have the innovation
in its final form but still not certified or ready to be manufactured in mass, the TRL can increase
up to TRL 6 or 7 can only be TRL8-9 when it can already be commercial.

3. How controlled are the conditions in which you are operating? This question measures the
completeness of your testing environment. Use this question to navigate in the row selected in
Question 1. The more real conditions you are (meaning elements out of your control may happen),
the closer you are to TRL9. If you are tested your innovation, independently of its form under
controlled scenarios, you are not beyond TRL6. Only when you have your product tested real live
in relevant timeframes, you can say that you are in TRL8. Obviously in those markets which
undergone regulations (health), the TRL is closely link to the phases you are concluding.

With the row obtained from Question 1 and the lower TRL value obtained from your responses from
Question 2 and 3, you calculate the TRL of the project. Use the examples of the tool to double check
that your project and the one in the example are in similar situations that justify your TRL assessment.

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4 THE TRL SELF-ASSESSMENT TOOL: MAIN ELEMENTS.
The TRL self-assessment tool is composed of 5 TRL scales, one per each of the type of solution to
be developed by the project, according to the Question 1. The description of the different TRL levels
is performed for each of the 5 cases according to their framing conditions, taking into accounts the
elements assessed in the Question 2 and 3. The completeness of the solution with respect its final
form and the completeness of the testing environment with respect th e final real environments of
application. A row of examples to be inspired is included per row taken from the Horizon Europe
Results platform.

In the following table, the TRL matrix can be found.

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 What is your
TRL 3 TRL 4 TRL 5 TRL 6 TRL 7 TRL 8 TRL 9
solution?
A functional version of
A manufacturable
Analytical studies on Basic technological Basic technological the product working
version of the product
separate elements of components components on a realistic Product in its final Product in its
working on an
the technology. integrated together to integrated within environment able to form working in full final form
A Product that is environment which
Laboratory based trials show that they work realistic context under draw conclusions on mode under under full
manufactured addresses all the
that show the together. At this a fully controlled the technical and expected conditions commercial
operational
feasibility of the point, durability is not environment in or operational and periods. deployment.
requirements for the
predictions. yet important. outside the lab. capabilities of the
product.
product.
Examples to be
link link link link link link
inspired
Development of a Demonstration plant
pilot-scale testing is constructed
Laboratory Process components Successful Commercial
Integrated validation plant or unit (1/100th (1/10th of
experiments are are validated demonstration of the plant/unit set
of the process to of commercial scale) commercial scale)
An industrial designed to verify that individually and could continuous operation up and running
produce small outputs including engineering- and operated in
process the conceptual be integrated in an ad of the pilot plant/unit for full range of
or short batches of scale equivalents of all continuous mode,
process works as hoc manner at lab during a relevant operating
the end product. the operations that including working
expected. scale. timeframe. conditions.
will be required at outside normal
scale. parameters.
Examples to be
link link link link link link
inspired
Stable version
Alpha version of the
Alpha version of the Beta version of the of the software
software tested Beta version of the
Initial script & software software Stable version of the available for
internally (both software
A software functions to solve the functionalities tested functionalities tested software available the market in
functionalities and functionalities widely
desired problem. by outsiders of the by selected end-user for the market. full business
process) by the open to end-users.
development team. under a control mode. plan
development team.
conditions.
Examples to be
link link link link link link link
inspired

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 What is your
TRL 3 TRL 4 TRL 5 TRL 6 TRL 7 TRL 8 TRL 9
solution?
Pre-clinical studies
including GLP (good Manufacturing
Proof of concept and
laboratory practice) process validated.
safety of the device is Medical device Medical device final
animal safety & Pre-market
demonstrated in vitro, prototype product design is
toxicity. GMP application
Initial proof of concept ex vivo or in vivo demonstrated in validated. Final
manufacturing submitted and Medical device
demonstrated with a conditions (non-GMP, operational prototypes intended
process and quality approved for ready to be
limited number of in Good Manufacturing environment. Clinical for commercialization
A medical device controls identified. medical device. acquired by the
vitro & in vivo trials Practice). System testing and safety use produced and
Classification of the Device clients and end
including the expected components demonstrated. tested. When
device by demonstrated in users.
device characteristics. integrated and tested Required applicable,
appropriated real life conditions,
regarding preliminary accreditation in accreditation
regulatory body support structure in
efficiency and progress. completed.
established. place for technical
reliability.
Accreditation when problems.
appropriate initiated.
Examples to be
link link link link link link
inspired
Phase 1 clinical trials
Pre-clinical studies
Proof of concept and completed to proceed
including GLP animal Phase 3 clinical trial
Initial proof of concept safety of the with Phase 2 clinical
safety & toxicity to Phase 2 clinical trial completed.
demonstrated with a candidate is trials. If it is the case, Drug available
A drug support the completed & Phase 3 Regulatory body
limited number of in demonstrated in a Investigational New for the market.
Investigational New plan is approved. approves IND
vitro & in vivo models. laboratory or animal Drug application
Drug (IND) application application.
model. submitted and
or similar EU process.
reviewed.
Examples to be
link link link link link link
inspired

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