Webinar on CE marking for EIC medtech beneficiaries — 24 May 2023

Brussels, May 11th 2023

Summary

›The European Innovation Council hosted a webinar on CE marking for medtech EIC beneficiaries on 24 May 2023 from 10.00 to 13.15 CEST.
›Regulatory experts from RQM+ and Ingecal delivered practical sessions for startups and EIC portfolio companies Diabeloop and Plasmacure presented real world cases.
›The event included live interaction via Slido and aimed to help EIC-funded organisations navigate EU medical device rules and conformity assessment.
›The webinar is presented as knowledge sharing and not as the official view of the European Commission.

Webinar on CE marking for EIC beneficiaries in the medtech area

The European Innovation Council invited EIC-funded organisations to a three hour webinar on CE marking for medical devices held on 24 May 2023. The session ran from 10.00 to 13.15 Central European Summer Time and was delivered online through Webex and a public webcast link. The programme combined regulatory presentations from experienced consultants with Q&A and two EIC portfolio company case studies.

Purpose and audience

The event targeted startups and scaleups in the medtech sector that are beneficiaries of EIC funding. The stated aim was to help those organisations understand pathways to CE marking in the European Union. Presenters were regulatory and quality experts who work with medical device developers, and two EIC-backed companies shared their implementation experience.

Speakers, cases and organisers

Organisers from the EIC introduced and closed the webinar. The main speakers were Bruna Koresch, Medical Device Consultant for Regulatory Affairs and Quality Assurance at Ingecal, and Andreas Tarnaris, Medical Director at RQM+. EIC portfolio companies Diabeloop and Plasmacure presented case studies. Interaction with the speakers was enabled through Slido for live questions.

Time (CEST)	Session	Presenter(s)
10:00 – 10:05	EIC Introduction	Enric Claverol-Tinturé (EIC / EISMEA)
10:05 – 10:50	CE marking for startups I	Bruna Koresch (Ingecal)
10:50 – 11:05	Q&A via Slido	All participants
11:05 – 11:15	Break
11:15 – 12:00	CE marking for startups II	Andreas Tarnaris (RQM+)
12:00 – 12:15	Q&A via Slido	All participants
12:15 – 12:25	Break
12:25 – 12:45	Case 1 - Diabeloop	Frédérique Boizet (Diabeloop)
12:45 – 13:05	Case 2 - Plasmacure	Bas Zeper (Plasmacure)
13:05 – 13:10	Closing remarks	Enric Claverol-Tinturé

How to access

The webinar was accessible via the European Commission webcast portal. The session was hosted on Webex for participants and streamed publicly. The access link used for the event was https://webcast.ec.europa.eu/ce-marking-webinar-2023-05-24

Practical topics covered and what they mean for startups

CE marking for medical devices explained:CE marking demonstrates that a medical device meets applicable EU legal requirements so it can be placed on the EU market. For medical devices this primarily means conformity with the Medical Device Regulation, known as MDR. The process typically requires technical documentation, clinical evaluation or evidence, risk management, a quality management system, and where applicable involvement of a notified body for conformity assessment.

Medical Device Regulation, MDR:The MDR replaced the earlier Medical Devices Directive. It imposes stricter requirements for clinical evidence, post-market surveillance, and traceability. Many products that were previously self certified now require notified body involvement. For innovators this means longer timelines and higher resource requirements.

Notified bodies:Notified bodies are independent organisations designated by EU member states to assess conformity for higher risk devices. Startups must identify an appropriate notified body early because of capacity constraints and variable acceptance criteria across bodies. Delays or backlog at notified bodies are a common bottleneck.

Technical documentation and clinical evaluation:Manufacturers must compile a technical file or design dossier that shows how the device meets essential requirements. Clinical evaluation means demonstrating clinical safety and performance through clinical data. For many novel devices, companies must design clinical investigations or build a robust evidence package from literature and real world performance.

Quality systems and post-market obligations:A compliant quality management system, typically aligned with ISO 13485, is expected. After placing a device on the market, firms must operate post-market surveillance and vigilance systems, maintain technical documentation, and submit periodic safety updates. These are ongoing obligations that require dedicated resources.

Why the EIC runs these sessions

The European Innovation Council runs business acceleration services and regulatory support for its beneficiaries. Workshops like this aim to reduce information asymmetry for startups that receive EIC support. The sessions bring regulatory consultants and experienced portfolio companies into dialogue with EIC-funded teams to share practical lessons and pitfalls.

What the webinar offered and its limits

The webinar offered practical high level guidance, Q&A and first hand accounts from Diabeloop and Plasmacure on their CE marking journeys. That can be useful for teams unfamiliar with regulatory pathways. However these types of sessions cannot replace project specific regulatory advice. Outcomes depend on the device risk class, clinical evidence needs, chosen conformity assessment route and notified body availability. Startups should treat webinar guidance as directional and seek formal regulatory and legal consultation for compliance decisions.

Context for EU medtech innovators

Since the introduction of the MDR, medtech innovators have faced a tougher regulatory landscape in Europe. The EIC and similar EU initiatives try to fill a gap by offering training and curated access to external experts. Still many startups report strain on budgets and timelines caused by expanded clinical requirements and constrained notified body capacity. For companies in the EIC pipeline, integrating regulatory planning early and budgeting for conformity assessment is essential.

Practical next steps for attendees

Startups that participated were advised to map their device classification, identify whether notified body involvement is required, begin compiling technical documentation, evaluate clinical evidence needs and adopt a quality management standard. Use the EIC Business Acceleration Services and regulatory support offerings where available, and log detailed questions for formal consultations. Live Q&A via Slido can help clarify general points but it is not a substitute for contractual regulatory strategy work.

Administrative notes and disclaimer

The webinar was offered as a knowledge sharing activity. The announcement included the following disclaimer that the information should not be interpreted as the official view of the European Commission or any other organisation. Topics associated with the event included biotechnology, engineering and technology, health, and public sector innovation. The lifecycle stages tagged were upscaling and expansion, and intellectual property and licensing was noted as relevant.

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