Medical Devices Newsletter - Issue 40 - August 2014
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newsletter_issue40_august2014.pdf
2 MB
Contents
Letter from the editor 1
Upcoming events: HPRA 1Medical devices information day
3D Printing: Potential in 2implants and surgery
What’s in a name? 4The IMB becomes the HPRA
Medical Device 5Information Notices
IMDRF Unique Device 6Identification (UDI)implementations for medical devices and IVDs
IMDRF Table of Contents (ToC) 8
Regulatory Updates 9
- Clinical investigation 9 cut-off dates
- Notified Body Operations 9 Group (NBOG)
- Compliance and Enforcement 9 Group (COEN)
- Joint Research Centre (JRC) 9
- Competent Authorities for 9 Medical Devices (CAMD)
- Medical Device 10 Expert Group (MDEG)
- Council Working Party (CWP) 10
- Clinical Evaluation 10 Investigation Working Group (CIEWG)
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