RFID (radio frequency identification) registration for Medical Device

QAengineer13

Quite Involved in Discussions
#1
Please share with me your experience of registering Medical device/IVD with RFID? I would like to know if the medical device registration and RFID registration in respective countries can happen parallely or does the product needs to registered before RFID registration, any input in relation to this wil be greatly appreciated!
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
A quick "Bump". Could be an interesting discussion. My Thanks in advance to anyone who will help with this one.
 

yodon

Staff member
Super Moderator
#3
Not my area of expertise by any means but in the spirit of trying to get the ball rolling, I'll toss in.

I'm really not aware of any registration that's required. Generally, I think, everything would be covered in product safety testing. I poked around and found the MET labs (no ties) had a fairly informative page: http://www.metlabs.com/industries/rfid/

You might consider getting in touch with someone there to provide details.
 

QAengineer13

Quite Involved in Discussions
#4
Thank you Marc and Yodon for jumping in to provide some help.

Yodon, I have already worked out the RFID registration requirement for different countries for example EU its the RED Directive and so on, the question was about the registration and even in that space I spoke to someone who has registered product with RFID recently and the answer seems to be country specific and they can be mostly done concurrently/ parallel with the MD/IVD registration.

Thank you, very much appreciate your input!
 

Highground

Involved In Discussions
#5
Not my area of expertise by any means but in the spirit of trying to get the ball rolling, I'll toss in.

I'm really not aware of any registration that's required. Generally, I think, everything would be covered in product safety testing. I poked around and found the MET labs (no ties) had a fairly informative page: RFID Testing for Safety, EMC, and Tag & Reader Interoperability

You might consider getting in touch with someone there to provide details.
This has helped me greatly! Can't find many test labs that can carry out this testing to meet the FDA requirements.
 

Highground

Involved In Discussions
#6
MET labs are unable to do the required testing for our Heart/Lung Machine with a new device that we need to test before our submission.
The labs are unable to reach the frequencies or levels of modulation.

Any suggestions?

AIM 7351731, Medical electrical equipment and system electromagnetic immunity test for exposure to radio frequency identification readers
 

yodon

Staff member
Super Moderator
#7
Look for other test labs that can. Off the top of my head, consider checking UL, Intertek, & Nemko (I have no skin in any of those games).
 
Thread starter Similar threads Forum Replies Date
M RFID (Radio Frequency Identification) Registration in Europe and in MENA countries EU Medical Device Regulations 1
Wes Bucey RFID (radio frequency identification) Tags - Inventory and WIP Tracking Misc. Quality Assurance and Business Systems Related Topics 19
P AIM 7351731 RFID reader immunity Other US Medical Device Regulations 2
Q UDI- RFID Labeling Other US Medical Device Regulations 4
F RFID Symbol for Medical Devices EU Medical Device Regulations 3
N RFID on a Medical Disposable Kit - Active Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
W Directives and regulations required for medical implants with RFID sensors ISO 13485:2016 - Medical Device Quality Management Systems 9
Wes Bucey U. S. Passport Security (RFID chips) World News 17
Marc Europe Adding RFID Tags to Euro Currency World News 3
F Is EMC + Radio Re-Test Required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Marc Definition RED = Radio Equipment Directive Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
T Testing bluetooth medical devices against Japan Radio Law requirements Japan Medical Device Regulations 2
R IEC 62304 - Medical Device Wi-Fi Radio Requirements IEC 62304 - Medical Device Software Life Cycle Processes 5
M Global Radio Frequency Regulations for Medical Devices Medical Information Technology, Medical Software and Health Informatics 3
M Radio Directive question about Wireless Device to Device Communication CE Marking (Conformité Européene) / CB Scheme 5
T GPRS (General Packet Radio Service) and EMC IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Is FCC required for Medical Equipment without Radio Frequency Energy? Other US Medical Device Regulations 5
Marc Tour of Manhattan from a Radio Controlled (RC) Plane Coffee Break and Water Cooler Discussions 4
Jim Wynne Tech Guy Radio: Woman Wants Help in Getting Her Stolen Internet Connection Back After Work and Weekend Discussion Topics 2
Tim Folkerts Pandora Radio - streaming *your* music Coffee Break and Water Cooler Discussions 24
J Re: Review my ISO 9001:2000 Quality Manual - Radio Broadcaster (Latvia) Quality Management System (QMS) Manuals 15
Marc Radio Controlled Airplanes Funny Stuff - Jokes and Humour 0
ScottK Save Internet Radio After Work and Weekend Discussion Topics 25
A Radio & Telecommunications Terminal Equipment Directive 1999/5/EC CE Marking (Conformité Européene) / CB Scheme 5
Marc Broadcast Radio Turns 100 World News 0
R Procedure, Frequency and Acceptance Criteria for Replicate, Recalibration, Before-After and Intermediate Checks ISO 17025 related Discussions 8
Q To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
M Define voltage and frequency to perform tests 61010-1 and 61326-1 for CE certification CE Marking (Conformité Européene) / CB Scheme 4
L Calibration Frequency for Surftest SJ-400 General Measurement Device and Calibration Topics 0
D Determining Calibration Frequency schedule for items used in production Manufacturing and Related Processes 2
G ISO 9001 - 9.3.1 Management Review - Content and Frequency Management Review Meetings and related Processes 12
H Frequency of shelf life/sterilization/bench studies conducted on a medical device Other Medical Device Related Standards 1
M Leakage current measurement with non-frequency-weighted device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Requirements for Interval Measurement test & Frequency Response test clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Radiation Sterilization Dose Audit: Bioburden frequency Other Medical Device Related Standards 1
bobdoering SPC Charting frequency calculator for X hi/lo chart Imported Legacy Blogs 0
D IATF 16949 surveillance audit frequency IATF 16949 - Automotive Quality Systems Standard 16
C AS9100 rev D 8.5.1 c 2 - Defining the Machine in-process frequency per ANSI/ASQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
J 95% reliability for calibration frequency Calibration Frequency (Interval) 7
R Internal Audit Frequency - Remote Site (a Design Center) IATF 16949 - Automotive Quality Systems Standard 3
V Periodic Audit Trail Review - Scope, Content & Frequency Qualification and Validation (including 21 CFR Part 11) 10
JoCam Required Frequency of Notified Body reviews of Technical Files EU Medical Device Regulations 6
J AMS 2750E System Accuracy Test (SAT) Frequency AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
B MHRA Unannounced Audits Frequency Changed? EU Medical Device Regulations 2
P IATF 16949 - Internal Audit Frequency Requirements Internal Auditing 2
P Frequency and Sample Size Requirements for an MSA Studies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Q Objective and Goals - ISO 9001:2008 Frequency Revision Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Sequence and Frequency of Calibration for Thread Gauges General Measurement Device and Calibration Topics 2
N Tool frequency change - Data Analysis needed Statistical Analysis Tools, Techniques and SPC 9
Similar threads


















































Top Bottom