EU MDR · CER · PMCF
How your CER stays alive, through PMCF.
Under EU MDR, the CER is not a one-off. PMCF findings must feed back into it, and into risk management, on a defined cadence. Here is how the loop works.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
The living clinical evaluation.
A CER that is not updated is a CER out of compliance. Ours are designed as a loop, not a document.
Pierre-Marie Boutanquoi
CERs and PMCF plans under EU MDR and MEDDEV 2.7/1 Rev 4, and Notified Body deficiency response.
in LinkedIn
Dr Mark Da Costa
Cardiac surgeon and former lead Notified Body reviewer at TÜV SÜD. 400+ devices CE-certified.
in LinkedInAwards, 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 loop
From PMCF finding to updated CER.
EU MDR treats clinical evaluation as continuous. The PMCF plan generates data, the PMCF Evaluation Report interprets it, and the CER and risk file are updated in response.
01
The feedback loop
Under Annex XIV, the PMCF plan defines what data you collect post-market. That data is analyzed in the PMCF Evaluation Report, whose conclusions must then be reflected in the CER, the risk management file (ISO 14971), the IFU where needed, and the PSUR.
02
What the update must capture
The updated CER has to show that the benefit-risk ratio remains acceptable in light of real-world data.
Into the CER
- New or confirmed clinical benefits and their magnitude
- Newly identified or emergent risks and side-effects
- Changes to the state of the art and to residual risks
- Any impact on claims, intended purpose or contraindications
03
How often to update
The cadence scales with risk: Class III and implantables update the CER and PSUR at least annually; Class IIa and IIb at least every two years or when significant new data emerges. A material safety signal triggers an update regardless of schedule.
04
Getting it right
The common failure is a PMCF report that never actually changes the CER. We design the PMCF plan so its endpoints map directly to the CER’s conclusions, so a reviewer can trace each post-market finding to its effect on the clinical evaluation.
The cadence
Continuous, not one-off.
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