How do medical device manufacturers choose the notified body?

 

　　The Notified Body is a testing, auditing and certification body designated by the competent authority of a member state of the European Union that is capable of engaging in one or more conformity assessment procedures as described in the appendix to the Medical Device Directive.The notified body must be located in a member state of the European Union.

　　Choosing a notified body is one of the most critical issues facing manufacturers. The time and financial resources spent on choosing a “buddy” with great care should be considered a future investment for the company In order to work effectively, long-term and close contact with the notified body should be established.

 

　　In general, manufacturers should consider the following factors when selecting a notified body:

 

　　—Experience in medical device certification;

 

　　—The range of medical devices that are familiar;

 

　　—Professional expertise, such as electromagnetic compatibility, software, etc.;

 

　　—Relationship with some of the principals and the qualifications of the client;

 

　　—The scope of authorized medical device certification;

 

　　—The scope of authorized medical device certification;

 

　　—Attitude towards existing certificates;

 

　　—cost;

 

　　—Location and working language.

 

　　For domestic medical device manufacturers, the selection of the notified body should consider those notable in the international market, and in the same industry for many certified manufacturers to choose the bulletin organization, so that you can take less detours.