ECP European Compliance Platform

Certification & Conformity Assessment

Third-party conformity assessment, CE marking, type examination and certification services from Notified Bodies and Certification Bodies across all major EU directives and regulations.

What is Conformity Assessment?

Conformity assessment is the process used to demonstrate that a product meets the requirements of applicable EU directives or regulations. Depending on the product category and risk classification, this may require involvement of a third-party body — either a Notified Body (NB) or a Certification Body (CB).

Notified Bodies are officially designated by EU Member State authorities and listed in the NANDO database. They carry out mandatory third-party assessment for regulated products under specific EU directives. Certification Bodies operate under accreditation schemes and issue certificates for voluntary or mandatory standards.

When is third-party certification required?

Notified Body involvement

Mandatory for higher-risk conformity assessment modules under:

  • Medical Devices Regulation (MDR 2017/745)
  • In Vitro Diagnostic Regulation (IVDR 2017/746)
  • Low Voltage Directive (LVD 2014/35/EU)
  • ATEX Directive (2014/34/EU)
  • Pressure Equipment Directive (PED 2014/68/EU)
  • Personal Protective Equipment (PPE 2016/425)
  • Machinery Directive / Machinery Regulation
  • Radio Equipment Directive (RED 2014/53/EU)

Certification Body services

Applicable for standards-based certification and product schemes:

  • ISO 9001 / ISO 13485 QMS certification
  • Product certification to harmonised EN standards
  • Type testing and certificate issuance
  • Factory inspection and surveillance audits
  • UKCA, UKNI and other market-specific schemes
  • Ecodesign and Energy Labelling requirements
  • Construction Products Regulation (CPR)
Typical certification process

Key stages

  • Identify applicable directive(s) and conformity assessment module
  • Select and engage a Notified Body or Certification Body
  • Pre-assessment and technical file review
  • Testing coordination and evidence collection
  • Audit (factory / QMS) if required by module
  • Certificate issuance and CE marking
  • Post-market surveillance and re-certification planning

How ECP helps

Submit one structured request describing your product, target directive, and timeline. ECP routes it to relevant Notified Bodies and Certification Bodies that cover your scope.

You receive provider responses with clear statuses, timelines, and next steps directly — without cold outreach, scattered emails or searching NANDO manually.

Before sending, you can run AI “Check application” to generate a structured summary and recommendations to improve response quality.

The platform tracks communication and keeps your project organised from first contact to certificate.

Relevant directives & regulations

MDR 2017/745 IVDR 2017/746 LVD 2014/35/EU RED 2014/53/EU ATEX 2014/34/EU PED 2014/68/EU PPE 2016/425 Machinery Regulation CPR 305/2011 Ecodesign 2009/125/EC GPSR 2023/988 ISO 13485 ISO 9001