The Compliance Management Group
257 Simarano Drive
Marlborough, MA 01752
Telephone: (508) 460-1400
CE Mark Self Certification
CE Mark Self Certification or CE Certification Self Certification is an option for some manufacturers, depending on their product. Some examples of product groups directives for which manufacturers can self-certify include:
- Safety of Machinery Directive
- Electromagnetic Compatibility (EMC) Directive
- Low Voltage Directive
- Class I products of the Medical Device Directive
- Most products covered by the Radio and Telecommunications Terminal Equipment (R&TTE) Directive
Manufacturers who CE Mark self certify must do the following:
- Decide whether the product needs to have a CE mark. If the product applies to more than one directive, it needs to comply with all of them.
- Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below:
- Module A – Internal production control.
- Module Aa – Intervention of a Notified Body.
- Module B – EC type-examination.
- Module C – Conformity to type.
- Module D – Production quality assurance.
- Module E – Product quality assurance.
- Module F – Product verification.
- Module G – Unit verification.
- Module H – Full quality assurance.
CE Mark self certifying eligible manufacturers will still need to verify the standards by which their product must comply. Please note that the CE Mark might require compliance to more than one directive.
Manufacturers not permitted to CE Mark self-certify must work with a qualified testing lab such as CMG. CMG works with manufacturers to test and certify a product for the CE Mark.
Not sure if you can CE Mark self certify? Contact CMG to discuss your product to determine the standards required in order to comply with the CE Mark.