EU MDR · Class III · Ophthalmology
Clinical evidence for Class III ophthalmic implants, that survives Article 61.
IOLs, MIGS and retinal implants that once enjoyed easy access now face intense scrutiny. Historical literature is no longer defensible. Here is the evidence strategy that holds up.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Reviewed by a former Notified Body ophthalmology assessor.
The person who would lead your file has assessed high-risk ophthalmic devices from the reviewer’s chair.
Dr Nikhil Khadabadi
As a former Notified Body assessor, Dr Khadabadi brings direct insight into how ophthalmic Class III submissions are scrutinised. He leads Eclevar’s strategic division, building pre-market investigations and PMCF architectures for high-risk ophthalmic implants that exceed Notified Body expectations.
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 paradigm shift
Why ophthalmic evidence just got harder.
Devices that once enjoyed straightforward access — intraocular lenses (IOLs), minimally invasive glaucoma surgery (MIGS) devices — now face intense clinical scrutiny under the strict framework of MDCG 2020-6. Sufficient clinical evidence is no longer just a regulatory hurdle; it is the determinant of commercial viability. Relying solely on historical literature is no longer defensible.
The four pillars of Class III ophthalmic evidence.
Article 61 investigation
A pre-market clinical investigation is strictly mandatory for novel Class III ophthalmic implants, designed and executed entirely in accordance with ISO 14155.
The equivalence barrier
Claiming equivalence for a Class III device now requires a legal contract ensuring ongoing access to the technical documentation of the presumed equivalent device.
Objective endpoint capture
Ophthalmic trials demand specialised capture: OCT imaging, strict IOP measurement protocols, and specular microscopy for endothelial cell counts.
Continuous PMCF
A CE mark is only the beginning. Long-term PMCF through registries or prospective observational cohorts is mandatory.
By device category
Notified Bodies scrutinise by mechanism of action.
01 / 03
Intraocular lenses (IOLs)
Refractive and cataract IOLs are judged on visual acuity outcomes, refractive predictability, and safety endpoints including endothelial cell loss measured by specular microscopy. A prospective investigation with adequate follow-up is the expectation for novel designs.
02 / 03
MIGS & glaucoma devices
Glaucoma devices hinge on IOP reduction, sustained over time and captured under strict measurement protocols, alongside medication burden and safety. The benefit must be demonstrated, not assumed from mechanism.
03 / 03
Retinal & high-risk implants
Novel retinal implants sit at the top of the risk ladder: a mandatory Article 61 investigation, objective imaging endpoints, and a PMCF architecture designed before the CE mark, not after.
The through-line
- Objective, instrument-based endpoints over subjective assessment
- Equivalence only with a contractual right to the predicate’s technical file
- PMCF designed into the strategy from day one
Ophthalmology evidence
What review now expects.
Talk to a reviewer
Is your ophthalmic clinical evidence sufficient?
Book a free strategy call with a former Notified Body ophthalmology assessor. We tell you whether an Article 61 investigation is required, how to design the endpoints, and how to build the PMCF.
Book a free strategy callFor a Class III ophthalmic implant, literature alone is a rejection waiting to happen.
An expert read tells you whether you need an Article 61 investigation, which objective endpoints a Notified Body will accept, and how to design the PMCF that keeps the CE mark valid.
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