Module 17 2024

Howard Dobbs

04/12/2024

Definition of Procedure Pack MDR Article 2(10)

‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

25

The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

25

Definition of Economic Operator MDR Article 2(35)

’economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3) (the procedure packer or system steriliser )

The procedure packer or system steriliser is known as the economic operator.

26

The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

26

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