When to file MDR - Significant Adverse Device Experience

M

mmg82

#1
I have been doing some research on when to file MDRs. For the most part, the regulation (21 CFR 803) is pretty clear. However, in a guidance document (Medical Device Reporting for Manufacturers) published in 1997 it states:-

A malfunction should be considered reportable if any one of the following is true:-

- it causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring, or diagnostic effectivenss which could cause or contribute to a death or serious injury, or other significant adverse device experiences.

My questions is, what is meant by a "significant adverse device experience"? Are there any examples?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
I don't think you're going to find a precise definition for that. Such language is a catch-all, intended to allow the regulatory authority to take action if the handling of an event in hindsight is recognizable as inadequate.

Regulatorily, the only way to manage such a clause is to report anything that might be questionable.

One of the reasons why the FDA has moved to electronic reporting is to deal with the considerably greater volume of reports that are generated under rules such as the above.
 
Thread starter Similar threads Forum Replies Date
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
Q When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K Technical file for mhra CE Marking (Conformité Européene) / CB Scheme 2
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
P Letter to file or special 510k or traditional 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
K Identification of hazards and Risk file IEC 62366 - Medical Device Usability Engineering 7
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
G Same intended use devices - Technical file EU Medical Device Regulations 5
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
A Bookmarking my security protected IEC 60601-1 .pdf file IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
R No design history file or device master record ISO 13485:2016 - Medical Device Quality Management Systems 5
R Suggestions for putting together a DHF (Design History File) ISO 13485:2016 - Medical Device Quality Management Systems 3
B We need a QMS: file-based templates or software Other Medical Device Related Standards 23
Sam Lazzara Medical Device File (MDF per 13485:2016 4.2.3) versus FDA Device Master Record (DMR) ISO 13485:2016 - Medical Device Quality Management Systems 3
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
D Questions about the contents of a Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 7
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
T Change to the FDA cleared device (ours) - Submission or Letter to file? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
M Medical Device News Olympus Medical pleads guilty to failing to file events notice: Justice Department Medical Device and FDA Regulations and Standards News 0
S Medical Device Cybersecurity Risk Management File ISO 14971 - Medical Device Risk Management 2
A The FILE recommended by AIAG MSA 4ed for LINEARITY Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
T Technical File Review - Transfer to a new NB EU Medical Device Regulations 3
K Letter to file vs Special 510 for additional accessory in orthopaedic kit Other US Medical Device Regulations 1
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 4
A DHF File - Shall the document cover all the variants? Design and Development of Products and Processes 2
C Medical device file for components such as adhesives, gaskets, films, etc. ISO 13485:2016 - Medical Device Quality Management Systems 13

Similar threads

Top Bottom