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

Background and policy context

The MDR and IVDR greatly rely on the capacity of notified bodies to certify such products, ensuring the placing on the market of devices compliant with the high level of safety and performance standard set out in the legislation. If notified bodies’ capacity falls short, the key objective of the legislation to secure access and availability of safe and performant devices to the health sector and ultimately to patients in the Union is jeopardised. There is therefore a need to increase capacity of notified bodies to secure a proper and smooth application of the legislation especially in IVDs, which is largely composed by SMEs and where the new Regulation identifies many new essential tasks to be performed by notified bodies with specialised expertise.

The limited capacity of notified bodies currently represents a bottleneck for those market operators that are ready to implement the Regulations but unable to find notified bodies available to certify their devices. On the other hand, several market operators have shown poor preparedness and incur delays to adapt to the high-level standards set up by the Regulations which has increased the expected time spent by notified bodies to certify such medical devices. In summary, the current situation raises serious concerns about potential risk of shortages and disruption of supply of devices, especially critical IVDs.

This action supports the policy priority to respond to support the implementation of the legislation and implements the EU4Health Programme’s general objective of strengthening health systems (Article 3, point (d)) through the specific objectives defined in Article 4, points (h) and (i), of Regulation (EU) 2021/522.

Objectives pursued

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.

Description of the activities to be funded under this topic

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;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;

b) Capacity building activities such as webinars, workshops, targeted feedback and informative sessions addressed to market operators;

c) 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;

d) 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.

Expected results and impact

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 of the new regulatory framework.

Specific mandatory deliverables and/or milestones

For the purpose of this action, medical devices shall be understood as medical devices and in vitro diagnostics medical devices, as defined in Article 2(1) of Regulation (EU) 2017/745 and Article 2(2) of Regulation (EU) 2017/746, respectively, unless otherwise specified.

The applicants should provide the following deliverables:

• For the activities related to point (a) and (b) of section C as above: at least two training sessions/year; in addition, for point (b) min number of participants 50.
• For point (a), market analysis to create a list of existing and potential new notified bodies (public or private) interested to receiving the training, coaching and internships; this list has to be kept up-to date for the all duration of the action.
• For point a) the internship activity has to be conducted at the manufacturer premises in order to increase the capacity building of existing and potential new notified bodies.
• For point (c), a manufacture’s survey should be carried out as soon as the action starts, ensuring a broad coverage of manufacturers placing medical devices on the EU market. In particular, the survey has to ensure inclusion of both EU and non-EU manufacturers, big companies as well as SMEs and should cover all the different types of medical devices (see devices codes listed in Regulation 2017/2185). An update of the survey (or more if needed) should be launched throughout the duration of this action.
• For (d), a proposed mechanism for notified bodies to provide updated information (to be kept as confidential) on their availability to certify medical devices in particular for in vitro diagnostics devices. This mechanism needs to be tested within the three months after the action starts.

Specific action-level indicators for reporting purposes

Applicants must be prepared to include data on the following specific action-level indicators in their regular reporting activities in case of award:

• List of EU and non-EU manufacturers identified, by size, by action of involvement and branch of activities described in section C (a) to (c)
• Number of existing and potential new notified bodies involved by branch of activities described in section C.
• Number of training, coaching and internship session developed
• Number of people and entities attending to the capacity building activities
• Number of new potential notified bodies on medical devices in accordance with MDR and IVDR.
• Number of certifications requests received by the notified bodies.

• The applicants are required to include in their proposals additional specific action-level indicators which will be agreed with the Commission during the grant agreement preparation.

The Commission may require the awardees to collect data for additional specific action-level indicators, where needed to complement the above indicators.