Accessories and Parent Device Submission

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C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
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L Programmer accessories classification EU Medical Device Regulations 0
E Configurable/Custom made or accessories? EU Medical Device Regulations 0
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
S How to register class IIA medical device accessories EU Medical Device Regulations 1
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
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B Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories" IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
K Medical Device Symbol(s) on Accessories EU Medical Device Regulations 28
M Informational FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017 Medical Device and FDA Regulations and Standards News 0
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
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E IEC 60601-1-2 compliance for accessories - Electromagnetic compatibility of the ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Medical Device Accessories - Health Canada - CMDR Section 21 Canada Medical Device Regulations 1
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M CE Scope on Medical Device & Device Accessories to the Foley Catheter CE Marking (Conformité Européene) / CB Scheme 2
Highground When are Medical Device Accessories MD's? Other Medical Device Regulations World-Wide 8
A Hundreds of Medical Devices & Accessories - 3 DHF's? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Medical Device Accessories vs. Detachable Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J 510k file requirements for non-sterile medical device accessories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B Applications required for main accessories (electrodes) of CE Medical Products EU Medical Device Regulations 4
D Separate Classifications for Medical Device Accessories EU Medical Device Regulations 2
M Who is the Manufacturer - Medical Device Accessories? EU Medical Device Regulations 6
M Providing accompanying Medical Device Accessories CE Marking (Conformité Européene) / CB Scheme 2
R RoHS Medical Devices: Application to Accessories, Components and Non-EE parts CE Marking (Conformité Européene) / CB Scheme 10
A Classification of Medical Device Accessories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
I CE Mark of Aviation Maintenance Trailer with Elevation Accessories (Jacks) CE Marking (Conformité Européene) / CB Scheme 2
R RoHS for Medical Devices - Does the directive apply to non-EEE accessories? RoHS, REACH, ELV, IMDS and Restricted Substances 1
Q Technical File for Medical Device Accessories CE Marking (Conformité Européene) / CB Scheme 4
S OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
N Dental Implants and their Accessories - CE Mark Conformity Assesment EU Medical Device Regulations 3
G Medical Device Accessories (e.g.: ECG Patient Cables) - Traceability Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
S Do HF Accessories need to perform a Risk Management Process of 60601-1:2005? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Selling Medical Devices and/or Accessories Online US Food and Drug Administration (FDA) 11
A Customized Medical Device Accessories for Research Purposes Only EU Medical Device Regulations 14
T Device Master Record For Medical Device Accessories ISO 13485:2016 - Medical Device Quality Management Systems 2
S Re-selling off-the-shelf (OTS) accessories for medical devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Do HF accessories require EMC testing according to IEC 60601-1-2? IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
H ISO10993 Requirements for Accessories Other ISO and International Standards and European Regulations 2
P Accessories or Spare Parts need CE MARK? Breast Pump Feed Containers EU Medical Device Regulations 2
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Marc GGG-G-15 - Gage Blocks & Accessories - Cancelled July 1999 General Measurement Device and Calibration Topics 0
G Parent Device as the Predicate for an Accessory Other US Medical Device Regulations 5
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5

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