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

145 words·~1 min read·/us/cfr/t21/s§ 803.17·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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

(a)Internal systems that provide for:

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

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

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

(b)Documentation and recordkeeping requirements for:

(1)Information that was evaluated to determine if an event was reportable;

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

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

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

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§ 803.17

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

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