CE 130. The 130 is the NB number. If you work with the same NB as that of your OEM and get the certificate, you will also use the CE 130. If you choose and work with an other NB, then when you get the certificate, you will use the number of your NB, alongside the CE. The CE mark is not transferable.1. if the OEM company has a product with CE marck (for instance CE 130)and PLM company sign agreement for the identical product, PLM now is the legal manufacturing and keep the CE mark from OEM (CE 130), does not it?
When the OEM company has the CE, they can label and place the device in the market. It is their business decision not to label if they so decide.1. how OEM company can obtain certificate of Directive 93/42/EEC, if it only designs and manufactures, OEM company do not labels the product, PLM (private label manufacturing) states the labeling?? please explain me.
OBL company exists only when the OEM company have the certificate. If you want to be the OBL company, you have to identify an OEM who has the certificate, or persuade a company to get the certificate.2. if OEM company would not have the certificate of 93/42/EEC, PLM company will request this certificate??
Yes. Rather, the OEM company will be then aware of the process of identifying significant changes and information to NB. It all depends on the type of change.3. considering the case that OEM company has own CE mark, when it decides to make some changes in the product, it have to inform to notified body??? the notified body considering the magnitude of the changes can be considered that the product needs certify again?
Post Market Survelliance4. please tell me what is he meaning of PMS??