MDR applies to all economic operators in medical device supply chain. Guidance applies to Class I devices except custom-made ones. More emphasis on life-cycle approach and clinical data
Bettis CBA300, CB, CBB-Series actuators meet basic health and safety requirements. Product variations are CE marked and covered by listed directives. Each actuator has an identifiable serial number
CE mark required for products covered by EU directives. Products without CE mark must provide documentation of non-compliance. Products must comply with national and EU standards in EEA
CE Mark exists, but CE Certificate does not. CE-Certificate can refer to EC-Certificate, EU Declaration of Conformity, or Type Examination Certificate
UL Certification is globally recognized safety mark for products. Underwriters Laboratories sets safety standards for over a century. Certification process includes product submission, testing, and factory inspection. UL Standards ensure safety and performance of various products
iPhone 6 silver 16GB model shows CE0682 on back. CE0682 is a four-digit code for EU Notified Body. Notified Body is independent, usually private company or non-profit. CE mark required for products meeting EU standards. Products with CE mark can be sold freely in all EU member states