First Aid Kit Assembler (CE Requirements)

[controlz]

We are a registered UK assembler of first aid kits through the MHRA. Currently we purchase a range of sterile and non-sterile CE marked first aid kit contents from a medical supplier and have these packaged in our own branded kit bag.

As of now, all of the contents have the logo of our supplier on them, however I wanted to find out what the legalities are of removing this branding so the contents merely display the CE mark with no reference to the manufacturer.

Many Thanks.

 

[Pads38]

All devices must be labelled with a manufacturer name and address, so you cannot simply remove the information.

However, what you can do is what is known as "Own Brand Labelling". To do that you need to set up an agreement between yourself and your supplier so that your details are shown as the manufacturer of record. You then are officially the manufacturer and hence would need to register as such with MHRA. You would also need to hold the "Technical Files" for your products.

This may sound overly complex but the big dressing manufacturers (for instance) are probably quite familiar with setting up OBM agreements.

As they would become specially labelled for you products they would cost more. And the Notified Bodies / Regulators are tightening up on their oversight of OBMs; they must have access to all technical details and cannot simply say that the original manufacturer deals with all the paperwork.

What this may mean is that you would need details of things like sterilization and validations.

 

[controlz]

All devices must be labelled with a manufacturer name and address, so you cannot simply remove the information.

However, what you can do is what is known as "Own Brand Labelling". To do that you need to set up an agreement between yourself and your supplier so that your details are shown as the manufacturer of record. You then are officially the manufacturer and hence would need to register as such with MHRA. You would also need to hold the "Technical Files" for your products.

This may sound overly complex but the big dressing manufacturers (for instance) are probably quite familiar with setting up OBM agreements.

As they would become specially labelled for you products they would cost more. And the Notified Bodies / Regulators are tightening up on their oversight of OBMs; they must have access to all technical details and cannot simply say that the original manufacturer deals with all the paperwork.

What this may mean is that you would need details of things like sterilization and validations.

Thanks for the prompt response. Would this be EVERY single product including things like plasters, or just the more sensitive contents such as sterile ones? (And is a logo of the manufacturer okay, or the physical address required?

I've noticed that a large majority of First Aid Kits on the market don't have actually any specific branding on the contents whatsoever - is this not allowed? See below:

www.amazon.co.uk/dp/B005SS7N18/

 

[controlz]

Regarding small loose items such as plasters, how do we get around the manufacturers address situation when they are too small to print an address on?

 

[rob73]

The MDD is quite specific about the information that is placed on the device packaging and labelling
13.3. The label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For
devices imported into the Community, in view of their distribution
in the Community, the label, or the outer packaging, or
instructions for use, shall contain in addition the name and
address of the authorised representative where the manufacturer
does not have a registered place of business in the Community;
(b) the details strictly necessary to identify the device and the contents
of the packaging especially for the users;
(c) where appropriate, the word ?STERILE?;
(d) where appropriate, the batch code, preceded by the word ?LOT?,
or the serial number;
(e) where appropriate, an indication of the date by which the device
should be used, in safety, expressed as the year and month;
(f) where appropriate, an indication that the device is for single use. A
manufacturer's indication of single use must be consistent across
the Community;
(g) if the device is custom-made, the words ?custom-made device?;
(h) if the device is intended for clinical investigations, the words
?exclusively for clinical investigations?;
(i) any special storage and/or handling conditions;
(j) any special operating instructions;
(k) any warnings and/or precautions to take;
(l) year of manufacture for active devices other than those covered by
(e). This indication may be included in the batch or serial number;
(m) where applicable, method of sterilization;
in the case of a device within the meaning of Article 1(4a), an
indication that the device contains a human blood derivative.
The labelling does not specifically be on the actual product (in this case plaster) but if you are drawing devices from various sources with different use by dates, lot numbers etc. It would be easier for it to be on the product itself.
In addition if the device is sterile, the CE mark must also bear the number of the notified body who accredit the sterilization process for the manufacturer. As pads38 said, the "easiest" way around this is an OBL agreement between you and the original manufacturer.

 

[controlz]

Thanks for the information. All of the contents would bear the CE mark along with expiry dates, STERILE markings and Lot numbers as stated in the directive.

Instead of having the manufacturer's address on each individual loose product, would it be acceptable instead to have a sticker stuck to the inside of the kit that states both:

Assemblers name and address.
Contents manufactured by [Name and Address]

If so, this would circumvent the issue of trying to print the manufacturers address on loose plasters / bandages!

 

[Ronen E]

Controlz,

You're looking down the wrong alley. There's an MDD article tailored exactly for this kind of situations - Article 12. Please have a look.

The problem with this kind of questions is that a full and responsible answer depends on many details, and requires a careful review. Generic answers will only get you so far. Sadly, for regulatory compliance it's not enough to be "roundabout" OK. You have to be spot on.

To get a full (give or take) answer you need 1 of 3:

1. A manufacturer who makes almost identical kits to yours - what are the chances that they will be willing to share?... They may even be your competitors.

2. A free agent who's dealt with exactly the same situation before and is willing to guide you pro bono. That's pretty rare, but maybe you'll get lucky...

3. A free agent who has the capability to look into your details and then guide you. What are the chances that someone would do that for free?... Are you willing to work full time for free?...

No offence, and this is not personal. This scenario recurs at least 1-2 times a week in the med dev forums (used to be more, when traffic here was higher), so I thought it's worth highlighting.

Cheers,
Ronen.