How to set up reporting rules

5 How to set up reporting rules

The recommended reporting rules that are needed when you enable eMDR report scheduling.

Country	License type	Agency	Rule Name	Time frame	Report Form	Condition
United States	Marketed Device	CDRH	5-day	5	eMDR	A criteria that uses Advance conditions with Remedial Action. Any other condition as per your company’s business process.
United States	Marketed Device	CDRH	30-day	30	eMDR	Case Serious = NO Criteria using Advance conditions with Malfunction = Yes Any other condition as per your company’s business process.

Country

License type

Agency

Rule Name

Time frame

Report Form

Condition

United States

Marketed Device

CDRH

5-day

eMDR

A criteria that uses Advance conditions with Remedial Action.

Any other condition as per your company’s business process.

United States

Marketed Device

CDRH

30-day

eMDR

Case Serious = NO

Criteria using Advance conditions with Malfunction = Yes

Any other condition as per your company’s business process.