You may need to look for a Notified Body if you determine that the product you manufacture is not subject to the self-certification compliance procedure. If that is your case, then it’s better if you take into consideration the following five things while choosing the notified body for your product’s conformity assessment:
- Usually, each notified body has a different fee and, unfortunately for you, you cannot send an application of your product to more than one notified body. That is the law, and because of it, you need to carefully choose the notified body for your product’s conformity assessment.
- Notified bodies often offer seminars and publish white papers and guidance materials, but do not provide consulting in addition to the certification services.
- The notified body must be able to provide you with both ISO 9000/13485 and Product Certification services.
- If you’re planning to import products, then try to find a notified body that will consider using auditors based outside of the European zone. In this way, you may be able to reduce the travel expenses associated with your product.
- Keep in mind that notified bodies have the right to perform unannounced audits, and such inspections are usually mandatory for medical devices.
Do you have a medical device that needs to pass a Notified Body assessment?
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