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TOPIC : Open Innovation Test Beds for Safety Testing of Medical Technologies for Health (IA)

Topic identifier: DT-NMBP-02-2018
Publication date: 27 October 2017
Focus area: Digitising and transforming European industry and services (DT)

Types of action: IA Innovation action
DeadlineModel:
Opening date:
two-stage
31 October 2017
Deadline:
2nd stage Deadline:
23 January 2018 17:00:00
28 June 2018 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Industrial Leadership
Work Programme Year: H2020-2018-2020
Topic Description
Specific Challenge:

The medical technology industry is an important economic and social player in Europe. The challenge is to provide companies and users in this sector access to affordable and advanced testing facilities and services to facilitate the development of new and safe medical technologies. The two new EU regulations[1] governing medical technologies (medical devices and in-vitro diagnostics) are introducing a new set of rules to improve the safety of medical devices for the benefit of patients. To preserve timely access to innovative healthcare solutions and support the competitiveness of the European industry, testing facilities support services are needed to help industry and users develop and test medical devices in compliance with EU safety regulations. A bonus would be to define new methodologies for clinical testing, when relevant.

Scope:
  • Open Innovation Test Beds should upgrade or develop materials facilities and make available to industry and interested parties, including SMEs, services for the design, development, testing, safety assessment, and upscaling of new/existing medical devices in compliance with EU regulatory frameworks since the beginning of the development process;
  • Test Beds could also contribute to develop methodologies to accelerate and simplify the subsequent pre-clinical and clinical testing in accordance with EU rules;
  • Potential regulatory, economic, organisational and technical barriers should be identified and assessed. Where applicable, considerations regarding risk-assessment procedures that take into account potential gender differences should be considered;
  • Open access at fair conditions and cost as well as outreach and dissemination across Europe, based on a distinct methodology;
  • Quality control processes and tools should be validated to allow on-line quality controls;
  • Medical devices should be demonstrated in relevant industrial environments.

Proposals submitted under this topic should include actions designed to facilitate cooperation, across Europe, with other projects; to enhance user involvement; and to ensure the accessibility and reusability of data produced in the course of the project.

Activities should start at TRL 4 and achieve TRL 7 at the end of the project.

The Commission considers that proposals requesting a contribution from the EU between EUR 7 and 15 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected Impact:
  • Open and upgraded facilities at the EU level for the design, development, testing, safety assessment, and upscaling of new medical devices easily accessible to users across different regions of Europe;
  • Attract a significant number of new SME users, with at least a 20% increase for existing test beds;
  • Cost effective, innovative, and safe healthcare medical devices in compliance with EU safety regulations;
  • Faster assessment of new medical devices' compliance with EU safety regulations;
  • Reduced time to market of new medical devices (earlier determination of safety profile and facilitation of subsequent pre-clinical and clinical testing);
  • Indirect substantial benefits for European citizens' safety and access to new and innovative medical products;
  • New market opportunities for providing services to non-EU players interested in testing facilities to ensure compliance with EU regulatory frameworks for their export products to Europe.

Relevant indicators and metrics, with baseline values, should be clearly stated in the proposal.

Cross-cutting Priorities:

Open Innovation
Socio-economic science and humanities
Gender

[1]Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Topic conditions and documents

1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.

 

2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme. 

Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.

 

3. Evaluation:

  • Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme. 
  • Submission and evaluation processes are described in the Online Manual.

The following exceptions apply:

Under 3 (a) Proposals are first ranked in separate lists according to the topics against which they were submitted (‘topic ranked lists’). When comparing ex aequo proposals from different topics, proposals having a higher position in their respective 'topic ranked list' will be considered to have a higher priority in the overall ranked list.
Under 3 (b) For all topics and types of action, the prioritisation will be done first on the basis of the score for Impact, and then on that for Excellence.

The threshold for the criteria Excellence and Impact will be 4.

The overall threshold, applying to the sum of the three individual scores, will be 12.

 

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (two-stage call):
For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

 

5. Proposal templates, evaluation forms and model grant agreements (MGA):

Innovation Action:

Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement

 

6. Additional provisions:

Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply

 

Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.

 

7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.

Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.

Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.

 

8. Additional documents:

1. Introduction WP 2018-20
5. Introduction to Leadership in enabling and industrial technologies (LEITs) WP 2018-20
5ii. Nanotechnologies, advanced materials, advanced manufacturing and processing, biotechnology WP 2018-20

General annexes to the Work Programme 2018-2020

Explanatory Notes on Open Innovation Test Beds

Open Innovation Test Beds Guidelines for Internal Management and Access Conditions

Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme

Additional documents

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