Module 18 2021

08/02/2021

EU Drug-device combinations

• Drug Product – primary action • EMA / national CA reviews the dossier

• Typically administration devices only • Separate administration devices must be CE marked • Additional information needed • Compatibility, functionality, safety / tox

The Organisation for Professionals in Regulatory Affairs

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EU Device-drug combinations

• Medical device – primary action • In the EU… the NB is the main regulating body

• Typically Class III devices (highest risk) • QUALITY SYSTEM control • Declared procedures and ER checklist • The MANUFACTURER has responsibility for safety and product liability (through the declaration of conformity) • Clinical benefit / risk (efficacy) of the ANCILLARY MEDICINAL SUBSTANCE must be evident

The Organisation for Professionals in Regulatory Affairs

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