SBS - The Best Value in QMS software

Wireless RF Regulations and Standards for Medical Devices sold in the EU

#1
Hello all,
Medical devices in the US that utilize RF technology (i.e. wireless communication) need to follow CFR FCC part 15. What is the equivalent regulation for marketing outside the United States (specifically, the EU)?

For reference, my medical device is both hardware and software that connects to a WiFi access points in a hospital and communicates data to specific end points on the network.

Thanks in advance for your help.
 
Elsmar Forum Sponsor

QAengineer13

Quite Involved in Discussions
#2
Hello all,
Medical devices in the US that utilize RF technology (i.e. wireless communication) need to follow CFR FCC part 15. What is the equivalent regulation for marketing outside the United States (specifically, the EU)?

For reference, my medical device is both hardware and software that connects to a WiFi access points in a hospital and communicates data to specific end points on the network.

Thanks in advance for your help.
Hi Whoosh929,

For EU, you need to comply to the new Radio Equipment Directive (RED) 2014/53/EU.
REF: http://ec.europa.eu/growth/sectors/electrical-engineering/rtte-directive_en

These RF regulations are independent to the Medical Device / IVD regulations and different countries have different regulatory agency for the Telecommunication for example) Brazil its governed through ANATEL, Mexico its COFETEL, Japan VCCI and these regulations also mandates certain labeling requirements as well. Hope this helps
 
Thread starter Similar threads Forum Replies Date
W Isolation requirements for Wireless ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q ME System - Is a Wireless Connection a "Functional Connection"? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Wireless Components requirements on Class 2 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S FDA Guidance on RF Wireless Technology and User Fees for 2014 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
F Wireless Dongle - Include in Medical Device Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
I Wireless Devices (Wi-Fi Module) as part of a Medical Device Other Medical Device Related Standards 3
M Radio Directive question about Wireless Device to Device Communication CE Marking (Conformité Européene) / CB Scheme 5
M Suggestions for Selecting RF Wireless Components Other US Medical Device Regulations 3
J Medical Device Wireless Labeling Requirements Other US Medical Device Regulations 3
S JQP Code - Wireless Data Transmission 510k only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S FCC Rules for Hospital Wireless Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Sidney Vianna McDonald's to offer free wireless - do you want fries with that? World News 15
Jim Wynne Wireless "G" Router/Access Point Recommendations, Please. After Work and Weekend Discussion Topics 8
Sidney Vianna Witricity - wireless electricity Coffee Break and Water Cooler Discussions 2
Marc Google Launches Free Wireless TiSP Broadband After Work and Weekend Discussion Topics 6
M Business Wireless network setup After Work and Weekend Discussion Topics 10
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
N Competitor not complying with regulations (EU) EU Medical Device Regulations 1
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
V Regulations renewal IATF 16949 - Automotive Quality Systems Standard 1
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Draft of New UK Regulations? UK Medical Device Regulations 2
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Warehousing two separate components to a finished device while meeting regulations Other US Medical Device Regulations 7
M Find updates to REACH and Rohs regulations REACH and RoHS Conversations 1
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
T Conflict Mineral Regulations Reliability Analysis - Predictions, Testing and Standards 1
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
J Interesting Discussion Compliance with regulations in exceptional circumstances EU Medical Device Regulations 5
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 10
G App - Local regulations applicable EU Medical Device Regulations 2
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
T Confirming The Local Safety Regulations for Equipment - I'm in Malaysia General Measurement Device and Calibration Topics 1
Q Regulations for Medical Device Kit for Training Personnel? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Medical device related standards or regulations - Disposed records log ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
P Is there a counterpart to the General Safety and Performance Regulations for the USA? Other US Medical Device Regulations 4
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
L Staying up to date on Regulations Other Medical Device Regulations World-Wide 8

Similar threads

Top Bottom