CE Marked IVD Labelling Canada - Conformity symbol?

Paperman

Starting to get Involved
#1
I work for a Dutch company that produces CE-marked IVDs for the European market.
We are in the process of drawing up a premarket review document for a medical device license application (MDL).

I have checked both the SOR/98-282 Medical device regulations and the Therapeutic Products Programme guidance draft document ?Guidance for the Labelling of In Vitro Diagnostic Devices?; Document Number GD012/RevDR-MDB; Draft Number (file: labl_ivd.wpd); Date prepared June 24, 1998.
I did not find information regarding possible Canadian labelling-requirements regarding conformity symbols and so I have the following questions:

The European IVD-directive states: ?Article 16; CE marking; 1. Devices (?) considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market?.

1) Does Canada have regulations/requirements regarding the placing of a conformity symbol like the European CE-logo on packaging and/or the directions for use?
2) Can IVDs accepted by Health Canada, and for which HC has issued a MDL, be sold in Canada with the CE-symbol of conformity on the packaging and/or directions for use?

Producing a new version of our instructions for use or labels is time consuming process for us so a quick response would be appreciated very much to enable a timely registration.

Thank you in advance for your information.
 
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DannyK

Trusted Information Resource
#2
1) Does Canada have regulations/requirements regarding the placing of a conformity symbol like the European CE-logo on packaging and/or the directions for use?
2) Can IVDs accepted by Health Canada, and for which HC has issued a MDL, be sold in Canada with the CE-symbol of conformity on the packaging and/or directions for use?
.
Your label can include the CE Mark but the label has to conform to Canadian regulations. The CE Mark symbol has no legal status in Canada.

What is the classification of the IVD in Canada?
 

Paperman

Starting to get Involved
#3
Your label can include the CE Mark but the label has to conform to Canadian regulations. The CE Mark symbol has no legal status in Canada.

What is the classification of the IVD in Canada?
Danny,

Thank you for your reply. It's good to know that we can maintain our label with the CE-mark as that reduces the amount of versions we have to maintain.
The devices we intend to sell are class III (good question, it reminds me to include that fact in correspondence).

Does Canada have a conformity mark of its own comparable to the CE-mark that must be placed on the label? I could not find any kind of requirement regarding that issue in the Canadian medical device regulations.

Kind regards.
 

DannyK

Trusted Information Resource
#4
Danny,

Thank you for your reply. It's good to know that we can maintain our label with the CE-mark as that reduces the amount of versions we have to maintain.
The devices we intend to sell are class III (good question, it reminds me to include that fact in correspondence).

Does Canada have a conformity mark of its own comparable to the CE-mark that must be placed on the label? I could not find any kind of requirement regarding that issue in the Canadian medical device regulations.

Kind regards.
There is no conformity mark in Canada. Labeling requirements can be found in Section 21-23 of the Canadian Medical Device Regulations.
 

Paperman

Starting to get Involved
#5
Thank you once again.

I checked sections 21-23 but did not feel secure there was not some additional thing somewhere (regulatory can have it's hidden "gems") so it's good to have it confirmed by a Canadian source.

Kind regards.
 

rangani_rj

Involved In Discussions
#6
Hi,

DRAFT: Guidance for the Labeling of In Vitro Diagnostic Devices

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/labl_etiq_ivd_div-eng.php

Its draft but can be used as no final guidance document available, also includes all citation of legal act (MDR).

You can find approved IVD similar to yours in Canada from below database and look at labeling visiting their website

Medical Devices Active Licence Listing (MDALL)
http://webprod5.hc-sc.gc.ca/mdll-limh/start-debuter.do?lang=eng
 

Paperman

Starting to get Involved
#7
Hi,

DRAFT: Guidance for the Labeling of In Vitro Diagnostic Devices

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/labl_etiq_ivd_div-eng.php

Its draft but can be used as no final guidance document available, also includes all citation of legal act (MDR).

You can find approved IVD similar to yours in Canada from below database and look at labeling visiting their website

Medical Devices Active Licence Listing (MDALL)
http://webprod5.hc-sc.gc.ca/mdll-limh/start-debuter.do?lang=eng
Thank you Rangani. I checked the draft guideas well as the MDR but neither mentioned explicit requirements for a conformity symbol. As it is usually the case, when there is a definitive yes or no, you know what you have to do or not do but the absence of explicit instructions creates room for doubt ("did I overlook something" or "did I read/ interpret it correctly").
One thing our notified body tells us from time to time during audits: "if you do something, write down what you did; if you don't do something write down a motivation. Never write nothing because then we're not sure whether you didn't simply forget to fill in the information".

Unfortunately the Medical Devices Active Licence Listing does not show images of the box so even though there is a device nearly identical to our device, I can't find out how it's labeled.

Kind regards.
 
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