ECP European Compliance Platform

Consulting & Documentation

Technical documentation, QMS consulting, gap analysis, labelling compliance and project coordination support for EU market access — from initial scoping to Declaration of Conformity.

What does compliance consulting cover?

Compliance consulting supports manufacturers and importers at every stage of the EU market access process — from understanding which requirements apply, to preparing the documentation needed for CE marking or conformity assessment.

Consultants help translate complex regulatory requirements into practical actions: what documents to prepare, how to structure the technical file, what testing is needed, and how to coordinate between different parties (labs, Notified Bodies, EAR providers).

Service areas

Technical documentation

  • Technical file / Design Dossier compilation
  • Declaration of Conformity (DoC) drafting
  • Risk assessment and risk management files
  • Essential requirements checklist
  • Instructions for use and labelling review
  • Technical documentation review and gap analysis

Quality Management Systems

  • ISO 9001 implementation consulting
  • ISO 13485 QMS for medical devices
  • QMS gap analysis and audit preparation
  • Process documentation and SOP development
  • Internal audit support
  • Certification body liaison and preparation

Gap analysis & roadmapping

  • Applicable directive and regulation identification
  • Compliance gap analysis against requirements
  • Conformity route selection and planning
  • Timeline and cost estimation
  • Multi-market access strategy (EU + UKCA, etc.)
  • Ongoing regulatory watch and update management

Labelling & product compliance

  • CE marking requirements and labelling rules
  • Language and content requirements per market
  • Ecodesign and energy label compliance
  • RoHS / REACH substance compliance review
  • Packaging and import marking requirements
  • Product registration and SCIP database notifications

Project coordination and multi-party management

Complex EU compliance projects typically involve multiple parties — testing laboratories, Notified Bodies, EAR providers, and sometimes regulatory authorities. Coordination between these parties is a key source of delays and cost overruns.

Consultants on ECP can take on a project management role — coordinating deliverables between labs, certification bodies, and documentation teams, maintaining the compliance timeline, and ensuring evidence packages are complete before submission to Notified Bodies.

Find compliance consultants through ECP

Submit a request describing your product, applicable directives, and what support you need — whether it's a gap analysis, full technical file preparation, QMS implementation, or project coordination. ECP routes it to consultants with relevant expertise.

Many consulting requests benefit from combining with other service types. ECP allows you to request consulting alongside testing or certification support — giving you a coordinated response from all relevant provider types in one process.

Before sending, you can run AI “Check application” to generate a structured summary and recommendations, so providers can respond faster and with fewer clarification cycles.

Relevant standards & regulations

CE Marking ISO 9001 ISO 13485 MDR 2017/745 IVDR 2017/746 RoHS 2011/65/EU REACH 1907/2006 GPSR 2023/988 Ecodesign 2009/125/EC LVD 2014/35/EU RED 2014/53/EU Machinery Regulation SCIP Database DoC / Technical File