Notified Bodies for In-Vitro Diagnostic Medical Devices
Notified Bodies are tasked with ensuring that certain classes of in-vitro diagnostic medical devices placed on the EU Market are safe and compliant. They assist the manufacturers to carry out conformity assessment procedures and grant conformity certificates to in-vitro diagnostic medical devices.
There are certain criteria that a Notified Body must meet before the EU Authorities can give them the official accreditation. Their role mainly consists of inspecting the technical documentation of Self-Testing IVD medical devices and IVDs listed on the Directive’s Annex II (list A and list B). Selecting a Notified Body for an in-vitro diagnostic medical device is an important process. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website).
- The Directive: IVDD 98/79/EEC
- Path to EU Market Entry
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
Selecting the right Notified Body for your EU Compliance requirements can be a daunting task. Contact us for help in your Notified Body Selection and Negotiation needs!IVDD Inquiries