Essentials of European Medical Device Regulatory Affairs

Module 1

• What is and what is not a medical device 

• Medical Device definitions

• Medicinal Products

• Combination/integral products

• Borderline Products

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Is the Product a Medical Device?

It could be a :

• Cosmetic Product

• Medicinal Product

• Biocide Product

• Toy

• New regulations acknowledge deciding where a product is regulated can be difficult !

6