There are different modules in CE Marking. Based on product construction & criticality different modules are chosen. These modules are as follows: –
- Internal Production Control : Manufacturer declares conformity with essential requirements & affix required CE conformity marking,
- Type Examination : Manufacturer submits to notified body – technical documentation, supporting documents of adequacy of technical designs, specimen, representative of the production envisaged.
- Conformity to Type : Manufacturer declares ‘EC Declaration of conformity’ with approved type & affixes required CE conformity mark
- Production Quality Control : Manufacturer operates an approved quality management system for production, final inspection & testing (ISO 9001:2015, ISO 13485:2016)
- Product Quality Assurance : Manufacturer implements an approved quality system for final inspection & testing and subsequently affix CE mark
- Product Verification : In this manufacturer declares conformity with approved type & affix CE mark
- Unit Verification : In this manufacturer submits technical documentation to certification company.
- Full Quality Assurance : In this a manufacturer operates an approved quality system for design, submits technical documentation to a notified body & a CE Notified Body carries out surveillance of QS