Adverse Event Reporting Flowchart (MDR EU)

#1
Hi!
Appreciate your assistance - could you share flowchart describing when a complaint is a reportable adverse event under EU MDR regulation?
Thanks!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
L Adverse Event Reporting New Zealand Other Medical Device Regulations World-Wide 11
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF proposed document – IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Anne Medical Device and FDA Regulations and Standards News 0
S Adverse Event and Serious Adverse Event Reporting - Korea Other Medical Device Regulations World-Wide 4
J Japan AE (Adverse Event) Reporting Requirements Japan Medical Device Regulations 5
R Reporting Times & Requirements for when an Adverse Event has occurred (Japan) Japan Medical Device Regulations 3
S AHWP Guidance on Adverse Event Reporting for Comments Other Medical Device Regulations World-Wide 0
M Major Revision to FDA Adverse Event Reporting Other US Medical Device Regulations 1
S Singapore - Revised Adverse Event reporting and FSCA Reporting Guidance Other Medical Device Regulations World-Wide 0
J Adverse Event Reporting Flowchart (US) - feedback appreciated! Other US Medical Device Regulations 4
J Adverse Event Reporting Flowchart (EU) - feedback appreciated! EU Medical Device Regulations 4
J Flowchart for Canadian Adverse Event Reporting - feedback appreciated! Canada Medical Device Regulations 3
bio_subbu GHTF issues guidance on Adverse Event Data Reporting Standard Other Medical Device Regulations World-Wide 0
N New MEDDEV 2.7/3 Guideline: Clinical Investigations: Serious Adverse Event Reporting EU Medical Device Regulations 4
E Taiwan Medical Device Adverse Event Reporting Other Medical Device Regulations World-Wide 6
C Adverse Event Reporting in Japan Japan Medical Device Regulations 8
bio_subbu OIG Reports on Medical Device Adverse Event Reporting system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Japan adverse event form Japan Medical Device Regulations 1
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
A Recall/Adverse event report procedures in Kuwait/Qatar/Kenya Other Medical Device and Orthopedic Related Topics 3
I Adverse Event Reported during Non-Approved Indication Use EU Medical Device Regulations 4
A Accessing Medical Device Adverse Event databases in EU CE Marking (Conformité Européene) / CB Scheme 7
B Looking for Adverse Event guidance US Food and Drug Administration (FDA) 7
V Where do I find Adverse Event Database for Medical Devices? Quality Manager and Management Related Issues 2
D Criteria for Reportable Event vs. Adverse Event in Device Studies US Food and Drug Administration (FDA) 9
T Reporting Adverse Events as Customer Complaints EU Medical Device Regulations 2
R New website bfarm recall & adverse events? CE Marking (Conformité Européene) / CB Scheme 4
Q Determining Adverse Effects of Corrective/Preventive Actions ISO 13485:2016 - Medical Device Quality Management Systems 2
M CER Adverse events - Justification of databases searched EU Medical Device Regulations 5
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
T MDR Adverse Events Assessments - What qualifications are required? Other Medical Device Regulations World-Wide 3
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 3
Q U.S. Agents - Responsibility for reporting adverse events to the FDA Other US Medical Device Regulations 10
I Where to submit Adverse Events Reports in Europe EU Medical Device Regulations 7
N Reason for determining no adverse effect on reworked product ISO 13485:2016 - Medical Device Quality Management Systems 8
S FDA terms - Adverse Events, Medical Device Reporting, MAUDE and Customer Complaints US Food and Drug Administration (FDA) 1
Q Documenting the Review of Adverse Effects from Rework ISO 13485:2016 - Medical Device Quality Management Systems 4
B Adverse Events and Product Recalls - Example forms and procedures wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Control of "manufacturing material" that has adverse effect on the medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Adverse Effects caused by Manufacturing Material of Medical Devices Manufacturing and Related Processes 4
D Subtleties of Adverse Events - How should it be captured and handled in the trial? Other US Medical Device Regulations 4
Q Supplier Audit Nonconformance: What if they adverse its certified QMS? General Auditing Discussions 12
M When to file MDR - Significant Adverse Device Experience 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Evaluating adverse effect on device tested with out of tolerance instrument General Measurement Device and Calibration Topics 3
R Should I be notifying the FDA of adverse effects (per 21 CFR 803)? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Why does GAGEpack drop the temperature and humidity readings out of the verification event card? Quality Assurance and Compliance Software Tools and Solutions 0
G When does containment event not require 100% sort? Nonconformance and Corrective Action 5
normhowe ASQ Storytime Event - Tell Us a Story ASQ - American Society for Quality 15
D Estimate Sample Size for very rare event Using Minitab Software 1
M Recurrent event analysis software (python) General Auditing Discussions 2

Similar threads

Top Bottom