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EU4H – Support increased capacity of notified bodies for medical devices – 2022

EU4H - Support increased capacity of notified bodies for medical devices, aiming at address 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.

2022-05-24
4 million euro
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Appeal framework

Institution European Commission
Sectors All sectors Health Research & Innovation
Beneficiaries All beneficiaries Association & NGO Local Authority & Affiliated Entity Research centre & university Training organisation & school
Regions Developing countries, European Economic Area, European Union
Details
  • EU Member States (including overseas countries and territories linked to it (OCTs))
  • Eligible non-EU countries : listed EEA countries and countries associated to the EU4Health Programme or countries which are in ongoing negotiations for an association agreement and where the agreement enters into force before the deadline for submission

 

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Priorities and funded actions

Objective

To address 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

Priorities

  • Priority 1: 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
  • Priority 2: contribute to secure availability of safe and performant devices in the best interest public health and patients’ safety in Union, thus safeguarding essential objectives of the new regulatory framework

Among financed actions

  • Supporting training, coaching and internship activities addressed to medical devices’ notified bodies as well as third-party entities 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

Additional information 

  • This call for proposals is an open call for proposals
  • Initial duration of the action: between 12 and 36 months

Eligibility

  • Be legal entities (public or private bodies)
  • Be established in one of the eligible countries
  • The consortium must include Notified Bodies with documented evidence on assessment of medical devices
  • The consortium should ensure a balanced geographical coverage of the Union
Financement
  • Total amount of the call: 107,3 million euro
  • Total amount of the topic “Support increased capacity of notified bodies for medical devices” : 4 million euro
  • Co-financing rate: up to 60% of the total eligible costs; or up to 80% if your project is of “exceptional utility”

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