The Medical Devices Introductory Course 2020

Medical Device Definition Key points

• Principle mode of action must be physical • As opposed to Medicinal products • Must be for use in/on human body • Must have a medical purpose or Annex XVI product under MDR • Can be software if it satisfies the above points • It must not be excluded from the scope of the MDD / MDR

The Organisation for Professionals in Regulatory Affairs

Active Implantable Medical device

Had its own Directive (90/385 EEC) • One Risk Classification – Class III Now included in the Regulation • Class III All AIMDs must be sold sterile

The Organisation for Professionals in Regulatory Affairs