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CE Certification - Medical Device CE Marking
CE Marking (CE Mark) is a mandatory requirement for medical devices to market in the Europe. Medical Device category includes, medical equipments, medical softwares, medical & surgical disposables, etc... CE Marking (CE Mark) is recognized worldwide as a symbol of quality. It consists of CE logo and four digit identification number of the certifying notified body (if applicable).
For a Medical Device manufacturer or Distributor, CE marking is the declaration that the product complies with all EU directives or EU regulations that apply to the medical device. CE marking does not implies that the product was made in the European Economic Area, but it states that the product is complying with the requirements of European Economic Area.
By affixing the CE marking, the manufacturer indicates that he / she takes responsibility for the conformity of the product. If importers or distributors market the products under their own name (OBL), the responsibility is transferred to the importer or distributor.
In Medical Devices Directive (MDD), the medical devices are classified in to four classes, class I, class IIa, class IIb, and class III. The certification of a Notified Body is not required for non-sterile and non-measurable medical devices of class I, but notified body certification is required for class I (s-sterile) and class I (m- measuring) devices.
LMG provide assistance from medical device classification through affixing CE Mark
Our services includes
- Medical Device Classification
- Identification of MDD requirements
- Identification of Harmonized standards
- ISO 13485 Implementation
- Identification of Notified Body
- Technical File preparation
- Technical File submission to Notified Body
- Technical file re-submission
- Assistance with Notified Body audit
- Assistance in closing non-conformities
- Affix CE Mark
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