Notified Bodies for Medical Devices

Notified Bodies for Medical Devices

Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market.  They help the manufacturers by carrying out conformity assessment  procedures and grant conformity certificates to medical devices. There  are certain expectations that a Notified Body must meet before being designated by the EU Authorities.

A key aspect of their role is  to inspect the technical documentations of MDD Is/Im, IIa and IIb as  well as review and approve Design Dossiers (for Class III devices) towards granting CE Certificates or EC Design Dossier Certificates. Manufacturers can consult the European Commission´s complete directory  of Notified Bodies (available on the NANDO website).

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Selecting the right Notified Body for your EU Compliance requirements can be a daunting task. Contact us for help in your Notified Body Selection needs!

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