Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi there,
For a medical device that contains an off-the-shelf, FCC-certified bluetooth device, is a separate NB assessment against the Radio Equipment Directive and declaration of conformity to this Directive required in addition to MDR compliance?
Thanks for any guidance on this!

To my knowledge: if the bluetooth device has a CE label and you do NOT  add a seperate antenna it should not be necessary to have a seperate NB assessment. By the way, in

Delegated Regulation (EU) 2022/30 it is made clear that not all essential requirements of the RED are applicable to MDR/IVDR devices.

------------------------------
Stephan Jansen
Quality Assurance Coordinator
Eindhoven
Netherlands
------------------------------

Original Message:
Sent: 26-Jan-2023 16:03
From: Anonymous Member
Subject: CE RED certification in EU

This message was posted by a user wishing to remain anonymous

Hi there,
For a medical device that contains an off-the-shelf, FCC-certified bluetooth device, is a separate NB assessment against the Radio Equipment Directive and declaration of conformity to this Directive required in addition to MDR compliance?
Thanks for any guidance on this!

Hello Anonymous

Yes in Europe your Notified Body will require assessment of testing you have done on the device incorporating the radio, to meet RED.  You should of course have access to your supplier's testing of the component to RED requirements. 

Remember that FCC certification only covers the US.  Almost every country has requirements for radio spectrum testing and labeling.  In EU it is RED, in Canada, regulated under ICES.  In Malaysia, testing to the MCMC mark,  and Australia, RCM marking, etc..

Have a certified test lab assess and/or perform testing to the RED requirements.  If you didn't  alter the radio at all, and have some supplier Certifications, perhaps you can do less testing of the device with it integrated into the design.  That is a "perhaps", but your test lab can help you assess that, including assessment of any safety concerns re: potential absorbance of the emissions.  RED should included on your DoC, since it is a CE Marking Directive.

Good luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 26-Jan-2023 16:03
From: Anonymous Member
Subject: CE RED certification in EU

This message was posted by a user wishing to remain anonymous

Hi there,
For a medical device that contains an off-the-shelf, FCC-certified bluetooth device, is a separate NB assessment against the Radio Equipment Directive and declaration of conformity to this Directive required in addition to MDR compliance?
Thanks for any guidance on this!

To clarify my response, I meant that if your device was undergoing NB review anyway (had to have NB involvement), they would certainly look at your RED compliance evidence and expect to see it on the DoC.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 27-Jan-2023 09:10
From: Ginger Cantor
Subject: CE RED certification in EU

Hello Anonymous

Yes in Europe your Notified Body will require assessment of testing you have done on the device incorporating the radio, to meet RED.  You should of course have access to your supplier's testing of the component to RED requirements.

Remember that FCC certification only covers the US.  Almost every country has requirements for radio spectrum testing and labeling.  In EU it is RED, in Canada, regulated under ICES.  In Malaysia, testing to the MCMC mark,  and Australia, RCM marking, etc..

Have a certified test lab assess and/or perform testing to the RED requirements.  If you didn't  alter the radio at all, and have some supplier Certifications, perhaps you can do less testing of the device with it integrated into the design.  That is a "perhaps", but your test lab can help you assess that, including assessment of any safety concerns re: potential absorbance of the emissions.  RED should included on your DoC, since it is a CE Marking Directive.

Good luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 26-Jan-2023 16:03
From: Anonymous Member
Subject: CE RED certification in EU

This message was posted by a user wishing to remain anonymous

Hi there,
For a medical device that contains an off-the-shelf, FCC-certified bluetooth device, is a separate NB assessment against the Radio Equipment Directive and declaration of conformity to this Directive required in addition to MDR compliance?
Thanks for any guidance on this!

Hi,
RED applies to medical devices if they include components (such as Wi-Fi or Bluetooth modules) that come under the definition of radio equipment in the RED and for which there are no special regulations in the MDR/IVDR.  All wireless products entering the EU market must do RED.
FCC certification doesn't make it RED certified Manufacturers must declare conformity with RED in addition to the MDR/IVDR.
If evidence of conformity with the RED can be provided entirely using harmonized standards, the manufacturer can issue a written EU declaration of conformity without involving a notified body.

If this is not the case, a notified body must be consulted. Harmonized standards are available for the most common frequency bands used by Wi-Fi, BT or RFID. The standards do not relate to a specific technology but instead to frequency bands.
Best is to connect with testing lab and do the assessment and get an issue CE-RED certification report.

Thanks

------------------------------
RAJE DEVANATHAN
Senior Manager
Oakville ON
Canada
------------------------------

Original Message:
Sent: 26-Jan-2023 16:03
From: Anonymous Member
Subject: CE RED certification in EU

This message was posted by a user wishing to remain anonymous

Hi there,
For a medical device that contains an off-the-shelf, FCC-certified bluetooth device, is a separate NB assessment against the Radio Equipment Directive and declaration of conformity to this Directive required in addition to MDR compliance?
Thanks for any guidance on this!

This message was posted by a user wishing to remain anonymous

Thanks for the responses, I appreciate the help and it confirms our thinking :)
Original Message:
Sent: 26-Jan-2023 16:03
From: Anonymous Member
Subject: CE RED certification in EU

This message was posted by a user wishing to remain anonymous

Hi there,
For a medical device that contains an off-the-shelf, FCC-certified bluetooth device, is a separate NB assessment against the Radio Equipment Directive and declaration of conformity to this Directive required in addition to MDR compliance?
Thanks for any guidance on this!