21 C.F.R. § 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:

(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.

Notes of Decisions

Cited in 1 case, 2018–2018 · leading case: Dennis Godelia v. Zoll Servs., LLC, 881 F.3d 1309 (11th Cir. 2018).

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Dennis Godelia v. Zoll Servs., LLC, 881 F.3d 1309 (11th Cir. 2018). “50(a)(1)”; (6) "Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets would be likely to cause or contribute'to a death…”

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