How a medical device Manufacturer chooses a Notified body
A notified body is a testing, auditing and certification body designated by the competent authority of a Member State of the European Union that may undertake one or more of the conformity evaluation procedures 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 faced by manufacturers. In order to be able to work effectively, a permanent and close relationship should be established with the notified body. Choose very carefully “ Partner ” The time and money spent should be considered an investment in the company's future.
In general, manufacturers should consider the following factors when selecting a notified body:
— Experience in medical device certification;
— Familiar with the range of medical devices;
— Professional expertise, such as electromagnetic compatibility, software, etc.;
— Relationships with certain principal parties and their qualifications;
— Authorized scope of medical device certification;
— An authorized compliance evaluation procedure;
— Attitude towards existing certificates;
— Costs;
— Location and working language.
For domestic medical device manufacturers, the choice of a notified body should consider those who have considerable visibility in the world, and in the same industry for many certified manufacturers to choose the notified body, so as to avoid detours.
