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Notified Bodies Relationship Myths and Realities: Effects of the EU Medical Device Regulations

Anthony Rizzo (Assistant Vice President Healthcare Development, BSI Medical Devices)

Location: 210D

Date: Tuesday, February 5

Time: 4:00pm - 4:45pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

Perhaps one of the most significant changes from the recent EU Medical Device Regulation is the expectations on the Notified Bodies. Previously sometimes seen as industry partners that would assist medical device companies with compliance and conformity assessments, Notified Bodies will now be the primary enforcers of the new regulations. Due to patient safety concerns, manufacturers can expect far more stringent certification requirements and increased intervention from enforcers.

Topics covered include:
  • How will the increased expectations affect medical device approval processes?
  • Understanding products that have changed classification and route of conformity under the new MDR
  • What effects will timelines and notified body designations have on CE approval?

Presentation File

Notified_Bodies_Relationship_Myths_and_Realities_Effects_of_the_EU_Medical_Device_Regulations.pdf