Call for proposals to support increased capacity of notified bodies for medical devices

Closed

Programme Category

EU Competitive Programmes

Programme Name

EU4Health Programme 2021-2027

Programme Description

The Programme aims to improve and promote health in the Union to reduce the burden of communicable and non-communicable diseases by:

  • protecting people from serious cross-border health threats
  • improving the availability, accessibility and affordability of medicines, medical devices and other crisis-related products in the EU
  • strengthening national health systems
Programme Details

Identifier Code

EU4H-2022-PJ-05

Call

Call for proposals to support increased capacity of notified bodies for medical devices

Summary

This action will contribute to addressing serious concerns about the lack of availability of vital devices in the medium to long term by increasing capacity of notified bodies and preparedness of market operators, in particular SMEs, with a particular focus on IVDs.

Detailed Call Description

Αctivities to be funded:

  • Supporting training, coaching and internship activities addressed to medical devices’ notified bodies as well as third-party entities (conformity assessment bodies) on the process to become a notified body for medical devices; a) Supporting training, coaching and internship activities addressed to medical devices’ notified bodies as well as third-party entities (conformity assessment bodies) on the process to become a notified body for medical devices;
  • Capacity building activities such as webinars, workshops, targeted feedback and informative sessions addressed to market operators;
  • Appraisal of the certification demand, with the objective to identify the types of devices for which availability of notified bodies is particularly low or lacking;
  • Proposing solutions to facilitate matching the demand of market operators with the availability of notified bodies, in particular in the area of IVDs where SMEs are prominent.

The action is expected to increase the capacity of notified bodies, increase preparedness of market operators in particular in the area of IVDs (including SMEs) and facilitating the match of demand from the market with the availability of capacity in notified bodies. This ultimately will contribute to secure availability of safe and performant devices in the best interest public health and patients’ safety in Union, thus safeguarding essential objectives.

Call Total Budget

€4,000,000

Financing percentage by EU or other bodies / Level of Subsidy or Loan

80%

Thematic Categories

  • Health

Eligibility for Participation

  • Central Government
  • Private Bodies
  • Small and Medium Enterprises (SMEs)
  • State-owned Enterprises
  • Training Centres

Eligibility For Participation Notes

In order to be eligible for funding, the applicants (beneficiaries and affiliated entities) must be legal entities (public or private bodies) established in EU Member States or EEA countries and countries associated to the EU4Health Programme (third countries, candidate countries and potential candidate countries, neighbourhood countries) or countries which are in ongoing negotiations for an association agreement.

For the specific eligibility criteria (including consortium composition and eligible applications) of each topic, please visit the detailed description of the topic of your interest in the call document.

Call Opening Date

22/02/2022

Call Closing Date

24/05/2022

National Contact Point(s)

Ministry of Health, Department of European Affairs

Ms MAKRIGIORGI Elena
emakrigiorgi@moh.gov.cy

(Publish Date: 25/02/2022-for internal use only)

EU Contact Point

Stefan DE KEERSMAECKER
Telephone: +32 2 298 46 80
Email: stefan.de-keersmaecker@ec.europa.eu

Darragh CASSIDY

Telephone: +32 2 298 39 78
Email: darragh.cassidy@ec.europa.eu