CE Marking Under the EU Regulations
EU MDR
& IVDR
The bar moved. The evidence has to move with it.
The bar moved. The evidence has to move with it.
MDR and IVDR raised the clinical and performance evidence bar for every device on the European market, reclassified thousands of products upward, and forced them through a notified body system with limited capacity and a long queue. A CE certificate is no longer a document you earn once; it is a state you maintain, tied to clinical evidence, post-market surveillance, and a quality system an auditor can walk into at any time. We build the technical documentation, clinical evidence, and notified body strategy that carry a device onto the market and keep it there. Europe is one leg of a wider map — compare it against the other regulatory pathways before you commit to a sequence.
Access to Europe now runs through evidence, a notified body, and a quality system that never sleeps.
Under MDR, the risk class determines whether a notified body is involved at all and how much clinical evidence you must bring. The higher you climb, the steeper the requirement, and misjudging it costs a year you do not have.
Mostly self-certified. A technical file, GSPR conformity, and a proportionate clinical evaluation. A notified body only for sterile, measuring, or reusable surgical devices.
Notified body required. A Clinical Evaluation Report and a sampled review of your technical documentation.
Notified body required, with stronger clinical data and a fuller documentation review.
Implantable and life-supporting devices. Full clinical evaluation, often a clinical investigation of your own device, and possible expert-panel scrutiny.
The same device, one class higher, means a notified body, a clinical investigation, and a longer queue.
Certification is not one submission. It is five bodies of evidence, each maintained continuously, and a weakness in any one is where the review stalls.
Documentation, clinical proof, and surveillance built for the way a notified body actually reads them.
Annex II and III, and their IVDR equivalents, define the file every device needs. The General Safety and Performance Requirements are the checklist your documentation is measured against, line by line.
The CER for a device and the Performance Evaluation Report for an IVD, where notified bodies concentrate their scrutiny and where thin evidence surfaces first.
ISO 13485 sitting behind the certificate, so an auditor arriving unannounced finds a system that runs the way the file says it does.
A proactive PMS plan, ongoing clinical or performance follow-up, and periodic safety update reports that feed straight back into the technical documentation.
Unique device identification assigned and EUDAMED registration in place, the operational front door that gates market entry before a single unit ships.
A CE certificate is necessary, not sufficient. A non-EU manufacturer needs a defined chain of legal actors, each with duties the regulation spells out, before the product can lawfully reach a patient.
The market-entry chain has to exist before certification turns into a sale.
Your EU-based legal stand-in, registered and named on the label, accountable to the competent authorities.
Verifies conformity before the device enters the EU and carries its own liabilities for what it places on the market.
Maintains storage, transport, and traceability conditions, and must act when it suspects a device is non-conforming — duties it owes independently, not by relying on the importer's verification.
The Person Responsible for Regulatory Compliance, a named, qualified individual the regulation requires you to have — and, under Article 15, one who needs real sign-off authority, not just the qualification file.
Thousands of devices certified under the old MDD, AIMDD, or IVDD still have to move to the new regulations before their transition deadlines, and the leap is steeper than it looks.
The share of IVDs pulled into notified-body scope under IVDR, many reviewed externally for the first time in their history.
Reclassification under MDR pushes many devices to a higher class, and a higher class means new clinical evidence.
Legacy certificates expire on a fixed timeline. The notified body queue does not care that yours is close.
MDR and IVDR are young enough that experience is scarce and decisive. Your leads are senior regulatory and quality practitioners who have written technical documentation, defended clinical evidence, and managed notified body relationships from application through certificate.
We settle the class before you build, because everything downstream, and the queue you join, depends on it.
We know how designated bodies review, where they concentrate, and how to prepare an application that does not bounce.
Both regulations, both evidence models, and the shared quality and surveillance systems underneath them.
Surveillance, PMCF, and EUDAMED data wired in, so the certificate holds through every audit that follows.
A device dossier draws on clinical, European, and combination-product expertise at once. These are the services it reaches for most.
The clinical evidence file the notified body reads first, planned and authored to pass on the first submission.
Explore CERs →How device certification fits the wider European route, across the EU, the UK, and Switzerland.
Explore Europe →Where a drug meets a device, and Article 117 requires a notified body opinion on the device part.
Explore Combination →Tell us about your device or IVD, its classification, and your target deadline. We'll assess your route to CE marking and match you with a senior European regulatory lead, with a response within one business day. All inquiries are strictly confidential.
