EU MDR · ISO 14155 · Pre-market
Pre-market clinical investigations, built for Notified Body approval.
For high-risk devices, literature and equivalence no longer clear the bar. A well-designed pre-market study is often the only route to CE mark. Here are the four pillars and when you need one.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Protocols designed by clinical and regulatory specialists.
A pre-market study that clears review is designed by people who know how Competent Authorities and Notified Bodies read a protocol.
Pierre-Marie Boutanquoi
Clinical investigation plans, Annex XV compliance and Competent Authority submissions under EU MDR.
in LinkedIn
Charline Petitdemange
ISO 14155 study conduct, EUDAMED registration and multi-country monitoring.
Awards, funding, accountability
Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →The four pillars
Four frameworks. All must hold.
The move from the MDD to EU MDR altered the path to market. A pre-CE mark investigation must satisfy multiple overlapping frameworks — and failure in any single pillar means rejection by a Competent Authority or Notified Body.
EU MDR Annex XV
Defines the strict legal requirements for clinical investigations in Europe: protocol structure, investigator brochures and sponsor obligations.
ISO 14155
The core Good Clinical Practice standard for medical devices: how trials must be designed, conducted and recorded.
GDPR
Patient data protection: pseudonymisation, explicit informed consent and certified health-data hosting (e.g. HDS in France).
Declaration of Helsinki
The ethical bedrock: patient safety and well-being prioritised over scientific or commercial interests.
When you need a study
By device class.
Not every device needs a new trial. The obligation depends on class and the availability of existing clinical data.
| Device class | Clinical evidence requirement | Pre-market study? |
|---|---|---|
| Class I & IIa | Clinical evaluation from literature, post-market data of equivalents and bench testing. | Rarely — only for novel technology, materials or a new intended purpose with no equivalent. |
| Class IIb | Comprehensive CER; equivalence claims heavily scrutinised. | Frequently — unless strict biological, technical and clinical equivalence is proven. |
| Class III & implantables | Exceptional scrutiny; Article 61 mandates investigations. | Almost always — exceptions are extremely narrow (e.g. legacy transition with robust data). |
Crucial regulatory update
EUDAMED registration, before first patient.
Managing an ISO 14155 pre-market investigation is now inextricably linked to EUDAMED. Sponsors and Clinical Project Managers must complete administrative workflows before recruiting a single patient.
Before recruitment
- Obtain a Single Registration Number (SRN) to identify the sponsor across EUDAMED
- Register the clinical investigation, including SADE reporting and annual progress reports
- Align the protocol, the CIP and the submission with the target Competent Authority — see our MDCG 2021-8 guide
Pre-market at a glance
What review now requires.
Talk to a specialist
Do you need a pre-market clinical investigation?
Book a free scoping call. We tell you whether your class and data require a study, design the ISO 14155 protocol, and handle the EUDAMED and Competent Authority workflows.
Book a free scoping callA protocol that fails one pillar fails the whole submission.
An expert read checks your pre-market study against Annex XV, ISO 14155, GDPR and the ethics framework, and confirms the EUDAMED steps, so the file clears Competent Authority and Notified Body review.
Consult our clinical expertsQuestions we hear first