Functions of Regulatory Bodies in Healthcare Essay

Part 1.  Explain the functions and roles of the following:

• Notified Bodies
• Competent Authorities
• HPRA
• EMA
• FDA
• IMDRF

Notified bodies

Notified bodies are an organisation managing the assessment and testing of products, and are more considered private bodies rather than government controlled (McDermott 2019). The European Commission produces a list of organisational bodies that serve to accomplish tasks associated with conformity assessment procedures before a product’s release on the market, especially during third party involvement. Manufacturers can avail of the assessment of compliance provided by the notified bodies in relation to public interest. Notified bodies must be informed by the relevant EU authorities of their range of power based on principles declared in Decision 768/2008/EC. Notified bodies can provide their service for any operator and on any territory, regardless of whether in the EU or not (Europa 2019). Functions of Regulatory Bodies in Healthcare essay Paper