The Mark Is Two Letters. Earning the Right to Print Them Is the Work.
CE marking strategy under the EU MDR and IVDR — the conformity route, the Notified Body relationship, and the technical documentation that let you place a device on the European market and keep it there.
Five Steps Stand Between Your Device and the Mark.
CE marking is the visible end of a conformity assessment. Under MDR and IVDR the path is defined — and for almost every device above the lowest risk class, a Notified Body sits in the middle of it.
Classify Under MDR or IVDR
The classification rule (MDR Annex VIII, or the IVDR rules) sets your class and, with it, the conformity route. Most software and diagnostics land higher than US teams expect.
Build the Technical Documentation
Annex II and III technical documentation: the device description, the clinical or performance evaluation, risk management, verification and validation — the file the Notified Body reviews.
Engage a Notified Body
For all but the lowest-risk devices, a designated Notified Body assesses your file and your quality system — and the shortage of MDR/IVDR capacity makes when you engage a strategic decision.
Draw Up the Declaration of Conformity
With the Notified Body certificate in hand, the manufacturer signs the EU Declaration of Conformity — the legal statement that underwrites the mark.
Affix the Mark — and Keep Earning It
The CE mark goes on the device. Then MDR’s post-market surveillance, vigilance, and PMCF obligations begin — conformity in Europe is continuous, not a one-time grant.
The Notified Body is the bottleneck, and the relationship.
Capacity is scarce and lead times are long. Which Notified Body, with which scope, engaged when — and how well your file survives their review — is usually the difference between an on-time European launch and a lost year.
Europe Grants Conformity, Then Expects You to Keep Earning It.
CE marking is not the European word for FDA clearance. It is a declaration of conformity to a regulation — underwritten, for most devices, by a Notified Body certificate — and it comes with continuing obligations that a US authorisation does not. Winning the US market does almost nothing to prepare the European file.
The two frameworks even moved in opposite directions: MDR and IVDR raised classification, deepened the clinical and performance evidence bar, and put a Notified Body in the loop where the old directives often did not. A device that self-certified under the directives can need a Notified Body under the regulations — a step-change most legacy portfolios are still absorbing.
Annex II/III technical documentation is the substance behind the mark — the clinical evaluation most of all.
Six Disciplines That Carry a CE Mark.
From the classification rule to the surveillance that keeps the certificate valid after launch.
MDR / IVDR Classification
Your class settled under the European rules — MDR Annex VIII or the IVDR classification rules — because the class chooses the conformity route and the Notified Body’s role.
Technical Documentation
Annex II and III documentation built to survive Notified Body review — device description, risk management, verification, and the clinical or performance evaluation at its core.
Notified Body Strategy
The right Notified Body with the right scope, engaged early against real capacity constraints — the single most schedule-critical decision in a European program.
Clinical / Performance Evaluation
The MDR clinical evaluation or IVDR performance evaluation planned and evidenced — the part of the file that fails the most Notified Body reviews.
Declaration & Marking
The EU Declaration of Conformity, the mark, and the labelling and UDI obligations that travel with it — the legal statement done right.
Post-Market Continuity
The PMS, PMCF, and vigilance system that keeps the certificate valid — because European conformity is a state you maintain, not a milestone you pass.
Surveillance, PMCF, and vigilance run for the life of the device — and the Notified Body audits them.
The Mark Is the Start of the Relationship, Not the End of the Project.
Once the device is on the market, MDR and IVDR expect a continuous loop: post-market surveillance, periodic safety update reports, post-market clinical follow-up, and vigilance reporting on clocks that start before you have finished investigating. The Notified Body audits that loop as hard as it audited the original file.
We build the post-market surveillance system and the EUDAMED obligations into the CE strategy from the start, so the certificate you earn is one you can keep — and so the next audit finds a system that has been running, not one assembled for the visit.
Six Failure Modes We Are Brought In to Prevent.
Most are a US-built file meeting a European framework it wasn’t designed for.
The Notified Body engaged late
A device ready to file and no Notified Body slot for months — capacity that should have been secured a year earlier, now the critical path.
A clinical evaluation that won’t hold
An MDR clinical evaluation built on thin equivalence or gaps — the most common reason a technical file comes back from review.
Directive-era self-certification
A legacy device still assuming it can self-certify — when MDR now routes it through a Notified Body it never planned for.
Classification underestimated
A product assumed Class I or IIa that the rules place higher — and a conformity route, and evidence bar, no one budgeted for.
PMS as an afterthought
A post-market system assembled after the mark — and a surveillance audit that finds a loop that has never actually run.
US file, translated
A 510(k) or PMA repackaged as a technical file — structurally wrong for Annex II/III, and visibly so to the reviewer.
European Market Access, Led by People Who Know the Notified Bodies.
Our European leads have built technical files, managed Notified Body reviews, and kept certificates valid through MDR and IVDR transition.
“The CE mark is two letters and a mountain of evidence. The teams that reach Europe on time are the ones who booked the Notified Body before the file was finished, not after.”
The discipline we bring to European conformity.
Heading for the European Market? Secure the Route — and the Notified Body — Early.
A senior European lead can settle your classification, shape the technical file, and get you in a Notified Body queue before the queue decides your launch date.
Senior-led. Embedded in your team. No junior hand-offs.