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Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices

European Commission

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:

Notified Bodies (NBs), device[1] developers and manufacturers adopt digitalisation in their conformity assessment procedures thus facilitating device development. As certain steps of conformity assessment do also require involvement of regulatory authorities (e.g. consultation of medicines authorities), digitalisation of these steps would also bring relevant benefit;
Device developers and manufacturers have access to digitalised conformity assessment procedures. These procedures will become more efficient, less onerous, and more predictable, which will reduce costs and shorten the time to market access;
Device developers and manufacturers, in particular small and medium-sized enterprises (SMEs), can direct a larger part of their resources towards the research and development of innovative devices.

Scope:

The regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR) have introduced stricter regulatory requirements in view of ensuring a high level of patient safety and public health. The implementation of the new regulatory requirements still remains a challenge for manufacturers. SMEs face particular challenges as they have limited resources to adapt to the new framework. One of the main issues reported by manufacturers is the complexity and perceived unpredictability of the conformity assessment procedure involving a Notified Body.

The Medical Device Coordination Group (MDCG) assists the Commission and the Member States in ensuring a harmonised implementation of the MDR and IVDR, notably through the development of guidance and templates. Notably, the conformity assessment procedures are still based on continuous exchange of highly complex technical documentation in an electronic format (e.g., pdf or excel files) between the key actors of NBs and manufacturers, requiring several iterations between them. Further digitalisation of this process (from document to data-driven processes) can bring greater efficiency, accuracy, and transparency and lead to a more predictable and harmonised assessment process. This is expected to reduce the administrative burden as well as certification timelines and facilitate the conformity assessment procedure for manufacturers, particularly SMEs. In turn, this will contribute to maintaining the EU as a business-friendly environment for all manufacturers, which will ultimately benefit patients. For example, digitalisation can lead to simplification through the reduction of administrative burden, use of a single-entry point for all exchange of information. If relevant, applicants may liaise with an ongoing study on supporting the monitoring of the availability of medical devices in the EU market[2]. Potential improvements related to digitalisation can include pre-defining mandatory data elements, the possibility of getting alerts on whether data is complete, the identification of missing parts and inconsistencies and a reduction of error rates in this regard. Overall improved communication would be anticipated with digitalisation.

Any actions as part of the proposal will be performed under the current regulatory framework and will not involve changing MDR/IVDR requirements. Proposals should present a major step towards digitalisation in Europe and Associated Countries. Governance of a potential IT infrastructure developed in Europe and Associated Countries is outside the scope of the topic.

The proposals should cover all the following points:

all steps of the MDR/IVDR procedures, from manufacturer’s preparation of technical documentation and other pre-application activities for certification to issuance of a MDR/IVDR certificate by a NB;
all actors involved in the conformity assessment procedure, including manufacturers, NBs, EU reference laboratories, expert panels of medical devices, as well as agencies involved in the consultation activities;
a good representation of different NBs, including representation from small and large NBs, public and private NBs and a representative mix focusing on medical devices and in vitro diagnostic medical devices. The proposal should put a strong focus on consensus building activities between the different stakeholders involved.

The proposals should address all the following activities:

Feasibility study
- Review existing initiatives aimed at digitalising MDR/IVDR conformity assessment procedures, or part thereof, and investigate digitalisation of conformity assessment/approval procedures for devices in other jurisdictions (e.g., US Food and Drug Administration). Consider lessons learned from digitalising conformity assessment procedures in other areas than medical devices.
- Examine basic processes/workflows established by individual NBs.
- Identify main steps of the conformity assessment procedure to be digitalised, actors involved, and essential elements and requirements to be considered prior to digitalisation.
- Collect and analyse feedback from main stakeholders on challenges and feasibility of the digitalisation process, identify interoperability with existing workflows used by manufacturers and/or NBs.
- Determine technical specifications required for the digitalisation as well as the possible options regarding digital transformation platforms.
- Analyse facilitating factors, main challenges, possible solutions and required resources.
Pilot
- Develop a pilot for the whole or part of the MDR/IVDR conformity assessment procedure, including Key Performance Indicators (KPI). This will involve collaboration with relevant stakeholders, including NBs, manufacturers, the European Commission and other involved parties.
- Develop a dedicated platform to run the pilot or identify an existing platform suitable for the pilot.
Roadmap towards digitalisation
- Based on the lessons learned from the pilot, identify different steps to scale-up the pilot in order to digitalise MDR/IVDR conformity assessment procedures, or part of them. Identify associated challenges and possible solutions to address these.
- Present a roadmap to the piloted approach, including possible alternatives, covering actors involved and resources needed.

AI Based Application Success Predictor

🧪 1. Scientific Excellence Is Paramount

For ERC grants, excellence is the sole selection criterion—evaluations focus exclusively on the quality of the research and track record .

Peer-reviewers adhere strictly to predefined criteria (e.g., Horizon ITN evaluations), and weaknesses—rather than strengths—often decide the outcome

🌍 2. Strategic Alignment with EU Priorities

Horizon Europe emphasizes Green & Digital Transitions and resilience, with specific budget steering across biodiversity, climate, digital, and societal missions .

Proposals that clearly align with these strategic orientations and EU missions are significantly more competitive.

🤝 3. Strong, Diverse European Consortia

Horizon projects demand well-balanced consortia across Europe—geographically and disciplinarily diverse, including academia, industry, SMEs, NGOs .

Effective leadership, communication, trust, and active collaboration are key success factors.

🧴 4. Proven Research Infrastructure & Track Record

A strong publication record—especially in high-impact venues—and prior grant awards bolster chances.

ERC starting, consolidator, or advanced grants require exceptional citation records, strong proposals, and investigator track records .

📈 5. Robust Project Management

For large collaborative grants, project coordination, administration, and communication are just as crucial as scientific content .

Demonstrating realistic budget planning (100% direct costs + 25% indirect costs), administrative frameworks, and governance structures strengthens proposals.

💼 6. Fostering Mobility & Career Growth

Marie Skłodowska-Curie fellowships emphasize researcher mobility, interdisciplinary training, and developing future talent.

🧷 7. Geographical & Gender Equity

Northern and certain Eastern European institutions currently have higher success rates (≈22% vs below 18% in Southern Europe) .

ERC gender data: male and female applicants have similar success rates, though male applicants apply more frequently .

📌 Key Takeaways

Factor	Why It Matters
Excellence-first	Superior science and investigator record are non-negotiable.
Strategic fit	Alignment with EU green, digital, and mission goals is essential.
Consortium quality	Geographic, sectoral, and expertise balance enhances impact.
Management capacity	Good PM builds confidence in successful delivery.
Experience track record	Publications, previous funding, and citations build credibility.
Mobility & careers	MSCA focuses on researcher development and interdisciplinary collaboration.

🧭 Applicant Tips

Master criteria & avoid weaknesses: Make sure your proposal addresses common reviewer pitfalls—methodology, innovation, budget clarity.

Map to EU priorities: Explicitly connect your objectives to Horizon Europe’s strategic plan (2025–2027).

Build strong consortia early: Prioritize complementary expertise, geography, gender balance, and partner roles.

Show robust project management: Include a Work Package structure, governance plans, and clear communication strategies.

Leverage your track record: Highlight high-impact papers, leadership in projects, and previous awards.

Consider MSCA opportunities: Use them for mobility grants or integrating training into your project.

✅ In Summary

To maximize success with European Commission grants—especially ERC or Horizon Europe—focus relentlessly on scientific excellence, strategic EU alignment, consortium strength, and solid project planning. Combine these with a strong publication record and researcher development elements, and aim to close off any potential reviewer concerns.

Specialties

Medical Devices

Eligibility Requirements

General conditions

1. Admissibility Conditions, Proposal page limit and layout

Admissibility Conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.

Proposal page limits and layout are described in Part B of the Application Form available in the Submission System.

2. Eligible Countries

Eligible Countries are described in Annex B of the Work Programme General Annexes.

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 Europe projects. See the information in the Horizon Europe Programme Guide.

3. Other Eligible Conditions

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.

Coordinators of projects must be legal entities established in an EU Member State or Associated Country.

If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).

Other Eligible Conditions are described in Annex B of the Work Programme General Annexes.

4. Financial and operational capacity and exclusion

Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.

5a. Evaluation and award: Award criteria, scoring and thresholds

Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

5b. Evaluation and award: Submission and evaluation processes

The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.

Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.

5c. Evaluation and award: Indicative timeline for evaluation and grant agreement

Evaluation and award: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.

6. Legal and financial set-up of the grants

Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].

Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.

Specific conditions

Specific conditions are described in the specific topic of the Work Programme.

Sponsor Details

Sponsor Institute/Organizations: European Commission

Sponsor Type: Corporate/Non-Profit

Address: Rue de la Loi 200, 1049 Brussels, Belgium

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