MDD 93/42/EEC
Amongst many other objectives, this directive is established to ensure that: "... medical devices must provide patients, users and third parties with a high level of protection and achieve the performances assigned by the manufacturer ..."
PED 2014/68/EU
This Directive has been created with several objectives in order to ensure devices including: "... that certain pressure equipment, although subjected to a maximum allowable pressure PS greater than 0.5 bar, does not present significant risks due to Pressure ... »