The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised Notified Body guidance documents.
The aim of such guidance is to address some of the best practice expected from manufacturers and Notified Bodies.
The guidance documents can be found on the below link:
1. NBOG BPG 2014-3 – Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System
2. NBOG BPG 2014-2 – Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities
3. NBOG BPG 2014-1 – Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules
4. NBOG F 2014-1 – Application form to be submitted when applying for designation as a notified body
5. NBOG F 2014-2 – Qualification of personnel (see NBOG BPG 2014-2)
Other articles related to the European Market:
Borderline and classification medical devices
FAQ Notified Body Unannounced Audits
Updated Harmonized standards MDD in Europe
If you are interested in the European Markets you can contact us for a preliminary discussion.