Regulatory Affairs Guidance Documents

Best Practice Standard:  Guideline for return of explanted and/or contaminated devices for inspection, investigation analysis, repair or disposal.

This MEDEC best practice document is to provide guidance and clarity to health care facilities and associated organization partners and stakeholders regarding the safe environment return of explanted and/or contaminated devices to medical device manufacturers, distributors or agents.

We encourage all stakeholders responsible for returning devices to become familiar with this best practice standard.

Please contact the associated medical device manufacturer / distributor or agent should you require any additional information regarding the safe return of products.

Best Practice Standard - English and French

Standard Form for Return - English and French