MDD: CE Marking Labeling Requirements - Two questions...

First Question: A contract manufacturer makes a medical device for a customer. That device is low risk and self certified. The contract manufacturer places the CE mark on the device for the customer... should they place a CE mark on the outer packaging label? In most cases the shippers are opened up for further processing at the customer's facility.

Another question - a company distributes a self certified device. The device is sold in packs of, say, 25. Each package has a label. Each shipper has a label. Do one, both, or neither of these labels require a CE mark?

Thanks very much for your help and any discussion resulting.

Re: MDD: CE Marking on labels - two questions...

Illuminatus said:

First Question: A contract manufacturer makes a medical device for a customer. That device is low risk and self certified. The contract manufacturer places the CE mark on the device for the customer... should they place a CE mark on the outer packaging label? In most cases the shippers are opened up for further processing at the customer's facility.

Another question - a company distributes a self certified device. The device is sold in packs of, say, 25. Each package has a label. Each shipper has a label. Do one, both, or neither of these labels require a CE mark?

Thanks very much for your help and any discussion resulting.

Click to expand...

Always on the device label as far as practicable. Then you do not want to miss out over the primary / secondary packaging and the user manual.
Note: As a contract manufacturer, just do what the customer wants.

Re: MDD: CE Marking on labels - two questions...

Illuminatus said:

First Question: A contract manufacturer makes a medical device for a customer. That device is low risk and self certified. The contract manufacturer places the CE mark on the device for the customer... should they place a CE mark on the outer packaging label? In most cases the shippers are opened up for further processing at the customer's facility.

Another question - a company distributes a self certified device. The device is sold in packs of, say, 25. Each package has a label. Each shipper has a label. Do one, both, or neither of these labels require a CE mark?

Thanks very much for your help and any discussion resulting.

Click to expand...

Hi,

If the CE mark is properly shown on the device itself (or on primary packaging if impractical on the device itself) then no other instances are *required*. Nevertheless, it is not prohibited to place additional marks on outer layers, as long as it is clearly indicated to what the CE mark refers (the device inside). In my opinion it is also good practice to have the CE mark appear on the outermost layer, on each supply chain leg. After all, the CE mark is intended to facilitate free movement of goods across the EC.

Cheers,
Ronen.

Re: MDD: CE Marking on labels - two questions...

Ronen E said:

Hi,

If the CE mark is properly shown on the device itself (or on primary packaging if impractical on the device itself) then no other instances are *required*. Nevertheless, it is not prohibited to place additional marks on outer layers, as long as it is clearly indicated to what the CE mark refers (the device inside). In my opinion it is also good practice to have the CE mark appear on the outermost layer, on each supply chain leg. After all, the CE mark is intended to facilitate free movement of goods across the EC.

Cheers,
Ronen.

Click to expand...

Hi Ronen,

Just a minor note; in exporting to some (non-EU) countries, if you put too much information on an outer shipper (especially if it indicates that it contains medical devices via CE mark etc) it may not arrive at the intended destination!

Steve

Re: MDD: CE Marking on labels - two questions...

SteveK said:

Hi Ronen,

Just a minor note; in exporting to some (non-EU) countries, if you put too much information on an outer shipper (especially if it indicates that it contains medical devices via CE mark etc) it may not arrive at the intended destination!

Steve

Click to expand...

Yeah, I was referring to shipments to/in the EU...

Re: MDD: CE Marking on labels - two questions...

Ronen:

Do you know if there is any guidance/directive that mandates the most severe warning listed in the IFU for a medical device to be first? And the least severe last? Or does it matter at all what sequence they are in according to their severity?

Thanks

Re: MDD: CE Marking on labels - two questions...

drewsky said:

Ronen:

Do you know if there is any guidance/directive that mandates the most severe warning listed in the IFU for a medical device to be first? And the least severe last?

Click to expand...

None that I'm aware of.

Re: MDD: CE Marking on labels - two questions...

Thanks Ronen. I did find "Guidance on Medical Device Patient Labeling" on the FDA website which suggest to present warnings according to clinical significance. See below.

General warnings and precautions:

Note: Please read the detailed discussion in Appendix E of definitions, purpose, content, format, placement, and other issues related to warnings and precautions.

Embedded in the concept of risk/benefit information is the type of information known as "general warnings and precautions." This is the specific hazard alert information that a user needs to know before using the device. Provide this information early in the labeling. Present it according to the clinical significance of the item to assist the reader in understanding the relative importance of the information. By the time readers get to the information on warnings and precautions in the labeling, they have probably already made the decision to use the device. At this point, the users know the global risks and benefits, but need specific information to avoid or reduce a particular hazard associated with the use or disposal of the device. It may be appropriate to include general warnings and precautions in a presentation of risk/benefit information for a device where that information might have bearing on the decision to use the device as well as on the actual safe use, operation, or disposal of the device.

Warnings and precautions tell the reader about hazards, other than those that are contraindications to device use. Warnings and precautions provide information on how to avoid these hazards, i.e., sources of harm in the use of the device.