The Medical Devices Introductory Course 2020

Importance of Classification

• Determines the Conformity assessment route selection • Level playing field for Manufacturers • Consistent decision making

• Regulatory compliance • Data exclusivity and IP • Protection of Public Health

The Organisation for Professionals in Regulatory Affairs

Conclusion on Classification

• Based on manufacturers intended purpose • Look at the product • Read the label • What are the ingredients and what is their function ? • Medical device classification is risk based and determined by the manufacturer’s intended use. • Medical device manufacturer is responsible for compliance

to law as stated in the Declaration of Conformity • Many borderline areas so discuss with experts

The Organisation for Professionals in Regulatory Affairs