The Medical Devices Introductory Course 2020

Guidance and Disputes

• Guidance in MEDDEV 2.4/1 Rev 9 • Repeats Annex IX • Explains definitions • Gives examples • Disputes • NB and Manufacturer must agree the classification • If they can’t then refer to the CA • MDR details process (Article 51) • CA in Country of Manufacturer involved • CA notifies MDCG and Commission of its decision

The Organisation for Professionals in Regulatory Affairs

Borderlines cases

Be aware that many Borderlines exist – Cosmetics – Biocides – Medicinal products – PPE – Software

Scientific data to support the primary mode of action is required where more than one mode of action occurs Intended purpose is key

The Organisation for Professionals in Regulatory Affairs