Technical Compliance File & CE Marking
As a manufacturer, importer, or distributor, placing a product on the EU market requires you to prepare a technical compliance file, a set of documents demonstrating compliance with all applicable directives, regulations and standards. This documentation must be made available to market surveillance authorities upon market entry and retained for 10 years. i-Comply offers a fully integrated service to handle this on your behalf. Working closely with your team and suppliers, we collect and review all necessary documentation and compile a complete technical file, stored on our secure cloud server or your own system, whichever you prefer.
- Risk assessment and product evaluation
- Test Verification & Lab Coordination
- Declaration of Conformity drafting
- Technical documentation package preparation
- Labelling and instruction review
- Liaison with Notified Bodies when required
Factory Audits & Product Inspections
Gain full visibility into your supplier’s capabilities, quality systems, and production output. Our on-site inspections and factory audits help you identify risks early, ensure compliance, and confirm that your products meet specifications before shipment.
- Factory Audits (Quality, Social, Technical, Environmental)
- Pre-Production Inspection (PPI)
- Initial Production Inspection (IPI)
- During Production Inspection (DUPRO)
- Pre-Shipment Inspection (PSI / Final Random Inspection)
- Container Loading Supervision (CLS)
- Supplier capability and quality system assessment
- Detailed digital reports ready the next day, including photo evidence
Technical Consultancy
Compliance is complex and constantly evolving. Our technical consultants work alongside your team to identify regulatory obligations early, optimise your testing strategy, and build a compliance roadmap that fits your business and budget.
- Regulatory obligation mapping for target markets
- Testing strategy and lab selection guidance
- Product classification and applicable directive review
- Supply chain compliance gap analysis
- Staff training and compliance awareness sessions
- Ongoing retainer support for fast-moving product lines
Hire the Expert
When market surveillance authorities, customs officials, or regulatory bodies come knocking, you need more than a consultant, you need a fiduciary expert who can represent your interests authoritatively and legally.
- Authorized Representative services (EU)
- Market surveillance authority liaison
- Product recall and withdrawal coordination
- Regulatory investigation support
- Expert witness and technical testimony
- Ongoing compliance advisory retainer
Container Loading Supervision
The final check before your goods set sail. Our inspectors verify carton quantities, packaging condition, and loading procedures at the factory gate, eliminating disputes at destination.
Quantity verification - Carton count matched against packing list
Packaging inspection - Carton condition and labelling checked
Loading monitoring - Stowage, bracing, and load distribution verified
Next-day report - Photo-documented report delivered the next day
Regulatory Updates
Regulations change, often without warning. i-Comply monitors the legislative landscape across all your active markets and delivers clear, actionable updates so you're never caught off-guard by a new directive, standard revision, or enforcement action.
- Continuous monitoring of EU, UK, and US regulations
- Plain-language summaries of regulatory changes
- Impact assessment for your specific product portfolio
- Deadline tracking and action plan recommendations
- New market entry regulatory briefings
- Subscription-based or project-by-project delivery
EU Authorised Representative
Under the General Product Safety Regulation (GPSR) and other EU legislation, non-EU manufacturers must designate an Authorised Representative established within the EU. i-Comply takes on this legal role, acting as your official point of contact with EU market surveillance authorities and ensuring your obligations are met.
- Designated Authorised Representative under GPSR 2023/988
- EU address and contact for market surveillance authorities
- Registration of products on the EU Safety Gate (RAPEX) portal
- Handling of consumer complaints and recall coordination
- Declaration of Conformity safekeeping (10-year obligation)
- Ongoing compliance monitoring and annual review