Weblinks in Medical Device Reporting Procedures

M

mr.mike

#1
Hi Everyone,

Wondering: Seeing as many (all?) regional regulatory agencies want to see a system procedural document for handling reporting & recalls, and seeing as most of these have explicit guidances posted on the net, is it not sufficient to simply have your SOP reference the appropriate website page?

In composing our SOPs I've included a statement like the following:

The ((regional website (link specified))) is the authoritative resource for the most current guidances and forms with respect to medical device reporting and recall. Where there is a discrepancy between the instructions in this SOP, and website guidances, it is the guidances that shall be followed. Reference current guidances here: ((website links)).
...but then I'm not really sure what else to include. Sure, the SOP has responsibility and record keeping requirements specified... but otherwise it's the official guidances that are authoritative. If it ever so happens (heaven forbid!) that we have to do a recall or mandatory adverse event reporting, I know I'll go straight to the appropriate website guidances. As such, I see no reason to essentially copy the guidances' directives when a simple web-link can specified.

Bottom line question: Aside from internal stuff (responsibilities, record keeping etc.), is it sufficient to just reference official guidance documents when composing SOP instructions for recall and reporting procedures?

As always, feedback greatly appreciated!
MM.
 
Elsmar Forum Sponsor
M

mr.mike

#3
Thanks! Good to know...

So in other words, Recall and Reporting SOPs can be pretty barren. Cutting out the meat and replacing it with weblink references, they might be only a page long!
 

Ajit Basrur

Staff member
Admin
#4
Thanks! Good to know...

So in other words, Recall and Reporting SOPs can be pretty barren. Cutting out the meat and replacing it with weblink references, they might be only a page long!
Also ensure that the personnel are trained on weblinks content too in addition to your SOP.

Another way to make it simple would be to add a flowchart prepared from the regulatory document to suit your organization !
 

medwise

Involved In Discussions
#5
One of the TGA (Australia) raised this as a non-conformance citing that sometime URL maybe broken if any change has been made. Also, the procedure has to be specific to the organisation's requirements and not all that is stated in the guidance or regulations maybe applicable to the company.
 

Ajit Basrur

Staff member
Admin
#6
One of the TGA (Australia) raised this as a non-conformance citing that sometime URL maybe broken if any change has been made. Also, the procedure has to be specific to the organisation's requirements and not all that is stated in the guidance or regulations maybe applicable to the company.
Great point ... is this finding on broken URL found on public domain ?
 
Thread starter Similar threads Forum Replies Date
N How do you control weblinks used for external document requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 0
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 1
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
M NICE Medical Technology Evaluation Programme - Recommendations Service Industry Specific Topics 0
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1

Similar threads

Top Bottom