§ 803.17 - What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?

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If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:

Internal systems that provide for:

Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;

A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and

Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.

Documentation and recordkeeping requirements for:

Information that was evaluated to determine if an event was reportable;

All medical device reports and information submitted to manufacturers and/or us;

Any information that was evaluated for the purpose of preparing the submission of annual reports; and

Systems that ensure access to information that facilitates timely followup and inspection by us.

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§ 803.16 - When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?

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§ 803.18 - What are the requirements for establishing and maintaining MDR files or records that apply to me?

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