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Approval

1. Information on the approval process in Europe

2. Information on the approval process in the Asian-Pacific Region

 

 

 

1. Information on the approval process in Europe

The conformity assessment proves that the medical device fulfils the basic requirements in accordance with European guidelines. In Europe medical devices are categorised into classes I, IIa, IIb and III, depending on the respective risk potential. Hip prostheses are in the highest risk class, III, which is why manufacturers must commission an independent testing agency, a so-called “notified body”. This notified body conducts a test and certifies the proof of product safety and effectiveness. Only then is the manufacturer entitled to place a CE mark on the product.  The „notified body“ is a private institution that is familiar with carrying out public tasks[ii].

 

 

 

 

2. Information on the approval process in the Asian-Pacific Region

The conformity assessment proves that the medical device fulfils the basic requirements of safety and performance. Hip prostheses are considered as medium to high risk medical devices which is why manufacturers commission an independent testing agency, a so-called “notified body”. This notified body conducts a test and certifies the proof of product safety and effectiveness. All hip prostheses are further subjected to local approval processes prior to their supply in the respective Asia Pacific countries/region.

 

 

 

 

 

 

 

 

 


[ii] Based on information from the Medical Device Directive MDD 93/42/EEC