Guides
Practical guides for structuring responsibilities, risk assessment, technical documentation, and evidence.
Guides
17 guides
CE Marking – Requirements and Responsibilities
What CE marking means, when it is required, and the responsibility a manufacturer assumes by affixing it.
Technical Documentation for CE Marking
What technical documentation should contain, how to structure it, and how long it must be retained.
EU Declaration of Conformity
Guide to the content, signing, responsibility, and version control of an EU Declaration of Conformity.
Product Risk Assessment – Practical Guide
Practical guide to hazard identification, risk evaluation, risk reduction, and product documentation.
Importer Responsibilities for Products in the EU
What an EU importer must verify before market access and the responsibilities that continue after launch.
Manufacturer Responsibilities under EU Product Rules
Manufacturer responsibilities from product design and assessment to documentation, marking, and corrective action.
Harmonised Standards and CE Marking
How harmonised standards provide presumption of conformity and how to document the correct edition.
How to CE Mark a Product – Step by Step
A practical process from applicable legislation and risk assessment to technical documentation and the CE mark.
DPP Data Requirements and Harmonised Standards
Guide to Decision (EU) 2026/1736, the six harmonised DPP standards, and presumption of conformity under ESPR.
PFAS in Products – Mapping and EU Status
How companies map PFAS in materials and components, prioritise data gaps, and track the ongoing EU restriction process.
SCIP Reporting – Requirements, Data, and 2026 Status
Who must report to SCIP, which article data is required, and how the proposed repeal affects planning in 2026.
Full Material Declaration (FMD) – Practical Guide
The difference between an FMD, substance declaration, and safety data sheet, and how material data supports compliance evidence.
Supplier Data for Product Compliance
A controlled process for requesting, validating, escalating, and versioning supplier compliance evidence.
BOM-Based Product Compliance
How materials, components, supplier evidence, and product variants connect into a traceable compliance assessment.
Distributor Responsibilities for Products in the EU
What distributors must check, document, and do when product non-compliance is suspected.
Notified Bodies and Product Certificates
When a notified body is required, how to check NANDO, and why voluntary certificates do not replace the correct conformity procedure.
Regulatory Change Management for Products
A controlled process for monitoring regulatory change, assessing impact, and reassessing products, documents, and supplier data.