Evidence-based Clinical and Pre-Clinical Strategies for the Evaluation of Medical Devices

This research defines evidence requirements for CE-marked high-risk devices, based on expert consensus and regulatory standards.

Use Cases
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Which medical devices really need clinical data for initial CE-marking?

For which devices may data from the generic device group together with
advanced testing be enough for initial CE-marking?

Is advanced non-clinical testing better suited to support patient safety
than pre-market clinical data for some devices?

What do advanced non-clinical testing strategies look like?

What is the role of PMCF in this context?

Background

The original Medical Device Directive (MDD, Council Directive 93/42/EEC) required clinical data “in particular” for implantable and Class III devices. It was only in 2007 that a clinical evaluation requirement was introduced for all medical devices. This culminated in the publication of the Medical Device Regulation (MDR, Regulation EU 2017/745) in 2017, spurred by high-profile device failures involving metal-on-metal hip implants and substandard silicone breast implants.

Despite these regulatory advances, significant uncertainty remains around the appropriate level of clinical evidence required for different types of devices. This lack of consensus affects manufacturers, notified bodies, and ultimately, patient safety.

ECliPSE seeks to resolve this ambiguity by developing robust, evidence-based strategies that define when and how clinical and non-clinical data should be used in medical device evaluation.

Methods

Our methodology combines qualitative and consensus-building approaches.

Evidence Mapping

We categorize and assess both clinical and non-clinical data needs for different device types and risk classes.

Expert Interviews

We conduct in-depth interviews with stakeholders including clinicians, engineers, regulatory professionals, and device manufacturers.

Delphi Study

A three-round Delphi process engages experts across disciplines to build consensus on evidence requirements.

Timeline

Start in April 2025

Use Cases Round 1

Start in November 2025

Use Cases Round 2

Start in October 2026

Use Cases Round 3

Start in October 2027

Analysis

Start in April 2028

Delphi Round 1

Start in October 2028

Delphi Round 2

Start in April 2029

Delphi Round 3

Use Cases Round 1 – Well Established Technology

This phase focuses on implantable and class III devices, either listed under MDR 61(6b) or expected to be included in the update scheduled for Q3 2025.
Expert interviews will be conducted with medical experts in the respective fields.

Suture

Classified as implantable, included in MDR 61(6b)

Bone Screw

Classified as implantable, included in MDR 61(6b)

Instruments for Neurosurgery

Basic surgical instrument, class III due to contact with the central nervous system

Introducer for Catheter/Stents

Simple design and no direct benefit, class III due to contact with the central circulatory system

Use Cases Round 2 – Active Medical Devices

The second round of use cases will focus on active medical devices. The primary emphasis of this phase will be on simulation and pre-clinical testing to validate interactions between the device and the human body in a non-clinical setting.

The following devices have been identified:

  • ICU ventilator
  • Electrosurgical generator
  • Insulin pump

Additional devices will be included at a later stage.
Expert interviews will be conducted with medical and technical experts in the respective fields.

Team

This collaborative research is led by:

  • Prof. Tom Melvin, University of Galway, Ireland
  • Prof. Dr. med Michael D’Agosto, Hochschule Furtwangen University, Germany
  • Elisabeth Oltmanns, Escentia GmbH, Germany

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