CE Marking —
The Honest Route Into the EU Market

No, and we want to be completely clear about this. A Notified Body is a conformity assessment body specifically designated by an EU member state to the European Commission under a particular product directive or regulation — a distinct, EU-specific regulatory status separate from IAF management-system accreditation. For product categories that legally require Notified Body involvement, we help you identify the correct requirement and coordinate access to an appropriately notified body; we do not ourselves issue Notified Body certificates.

It depends entirely on your product and its risk classification under the applicable directive(s). Many product categories allow manufacturer self-declaration (Module A) based on your own technical file and testing against harmonised EN standards. Higher-risk categories — including most machinery, medical devices above certain classes, pressure equipment above set thresholds, and Category II-III PPE — legally require Notified Body involvement.

Cost varies enormously by product risk category — from around €500 for simple, self-certified products up to €50,000+ for high-risk medical devices or AI systems requiring extensive Notified Body assessment. London Cert provides a specific estimate for your product during your free consultation.

Simple self-declared products can be compliant in a few weeks; products requiring Notified Body assessment (particularly medical devices or complex machinery) can take several months, since third-party testing and evaluation adds significant time.

It's a signed legal document, prepared by the manufacturer (or authorised representative), declaring that the specific product meets all applicable EU requirements. It must be available to market surveillance authorities on request and is a core part of your CE Marking obligations.

Increasingly, yes. The Cyber Resilience Act extends CE Marking obligations to "products with digital elements" from December 2027, requiring vulnerability handling processes and free security updates.

No. UKCA is the UK's separate, post-Brexit conformity mark for the Great Britain market. CE Marking and UKCA overlap significantly in structure but are legally distinct systems — a product CE-marked for the EU does not automatically satisfy UKCA requirements for GB, or vice versa.

A "substantial modification" — which can include some firmware or software updates, not just physical changes — can re-trigger the need for a full conformity re-assessment.

Only for product categories covered by EU harmonisation legislation. London Cert's initial scoping consultation determines whether your specific product falls within CE Marking's scope at all, and if so, which directives apply.

Many manufacturers do. ISO 9001 or sector-specific standards like ISO 13485 demonstrate organisational quality management and are often expected by EU buyers alongside CE Marking, even though they aren't formally required for the mark itself.