MDD Definition of Address as it applies to Medical Device Labeling

L

LHAMROWCT

#1
Can anyone tell me the MDD definition of "address" as it applies to medical device labeling? Does it have to be a street address, or is the name of the company and the city, state, country and zip code sufficient? Thanks!
 
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Ajit Basrur

Staff member
Admin
#2
Re: MDD Definition of Address

Can anyone tell me the MDD definition of "address" as it applies to medical device labeling? Does it have to be a street address, or is the name of the company and the city, state, country and zip code sufficient? Thanks!
Welcome to the Forum :bigwave:

I dont think there is any definition for "address" - just use the address identical to your correspondence address :)
 

bio_subbu

Super Moderator
#3
Re: MDD Definition of Address

Can anyone tell me the MDD definition of "address" as it applies to medical device labeling? Does it have to be a street address, or is the name of the company and the city, state, country and zip code sufficient? Thanks!
In MDD directive 93/42 EEC, Annex I, point 10.3 says that the label must bear the name or trade name and address of the manufacturer. Not specifically say about whether street, city or state.

The minimum address information required is the manufacturer name, postcode and country, if this is sufficient to allow the customer to contact the manufacturer and, if necessary the manufacturer’s agent within the EU. However, because space is not usually a critical issue in the documentation accompanying the device (in instruction manual), it is advisable to include the full postal address along with a telephone number.

Thanks and Regards
S. Subramaniam
 

sreenu927

Quite Involved in Discussions
#4
Hii..
It reminds me to share my experience during our recent MDD audit.

We have our company's corporate address on the label and IFU. where as audit was conducted at manufacturing site and our ISO 13485 too has manufacturing site address.

Now the auditor has given NC for not having the "legal manufacturer address" on our labels and IFU.

So which is called " (legal)address of the manufacturer"?

Need ur thoughts n experience.

Thanks & Regards
Sreenu
 

Ajit Basrur

Staff member
Admin
#5
Hii..
It reminds me to share my experience during our recent MDD audit.

We have our company's corporate address on the label and IFU. where as audit was conducted at manufacturing site and our ISO 13485 too has manufacturing site address.

Now the auditor has given NC for not having the "legal manufacturer address" on our labels and IFU.

So which is called " (legal)address of the manufacturer"?

Need ur thoughts n experience.

Thanks & Regards
Sreenu
Probably the one registered with the authorities :tg:
 

bio_subbu

Super Moderator
#6
Hii..
It reminds me to share my experience during our recent MDD audit.

We have our company's corporate address on the label and IFU. where as audit was conducted at manufacturing site and our ISO 13485 too has manufacturing site address.

Now the auditor has given NC for not having the "legal manufacturer address" on our labels and IFU.

So which is called " (legal)address of the manufacturer"?

Need ur thoughts n experience.

Thanks & Regards
Sreenu
Hi Sreenu

The label should bear the address of the manufacturer’s registered place of business. If the manufacturers registered place of business in not in the European Union (EU), the label of the outer packaging or the IFU must also bear the name and address of the manufacturer’s authorized representative. The point is to enable the customer to contact someone with in the jurisdiction of the EU who can take responsibility for the product. For more information refer standard EN 1041:2008 (Information supplied by the manufacturer of medical devices).

Thanks and regards
S. Subramaniam
 
A

Adele

#7
During an audit last year, our Notified Body said that our address details of the Authorised Representative should be sufficient that a letter written using the address given on the label will be able to be delivered.

We also have our full manufacturer address in order to meet complaince with Canadian requirements.
 
R

raj-indez

#8
Hii..
It reminds me to share my experience during our recent MDD audit.

We have our company's corporate address on the label and IFU. where as audit was conducted at manufacturing site and our ISO 13485 too has manufacturing site address.

Now the auditor has given NC for not having the "legal manufacturer address" on our labels and IFU.

So which is called " (legal)address of the manufacturer"?

Need ur thoughts n experience.

Thanks & Regards
Sreenu

The basic rule is that the address at which the audit is done and the ISO is granted is the address of the "Legal manufacturer", as per my understanding. The corporate body is is just the parent company, thats all.
The EC REP has to be mentioned in the label and the IFU if the company is not situated in the EU.
 
R

Rolande Hall

#9
Can anyone tell me the MDD definition of "address" as it applies to medical device labeling? Does it have to be a street address, or is the name of the company and the city, state, country and zip code sufficient? Thanks!
Hi Folks,

I just came across this topic and decided to add my two pennyworth.

The MDD 93/42/EEC states the 'manufacturer' means the natural or legal person with the responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The MDD does not say that the address of the manufacturer must be
the same as the location at which the manufacturing operations are conducted. Many medical devices are physically produced in one EU country yet bear the address of the responsible manufacturer who is located in another EU state.

As for the address itself good advice came from S. Subramanian :thanks:when he recommended referal to EN 1041 which states on this topic
"The full postal address may not be necessary provided that the address is of sufficient detail that the manufacturer, and if the device is imported into the community, the person responsible, the authorized representative, or the importer can be contacted, e.g., name or trade name, post code and country."

In the US read "zip code" for "post code", in the Rep of Ireland and other countries without a postal code sufficient detail is required more detail is needed.

Thanks for raising an interesting topic.
Rolande
For more information refer standard EN 1041:2008 (Information supplied by the manufacturer of medical devices).

Thanks and regards
S. Subramaniam
14th May 2009 04:03 AM
 
A

Adele

#10
When they talk about the "legal manufacturer address", they are referring to whomever the legal manufacturer is. This may be different from the actual manufacturer.

I argued the same clause from EN1041 to our Notified Body - "The full postal address may not be necessary provided that the address is of sufficient detail that the manufacturer, and if the device is imported into the community, the person responsible, the authorized representative, or the importer can be contacted, e.g., name or trade name, post code and country" - as justification for only having the P.O. Box number on the label. My argument was unsuccessful. The reasoning being that the section of EN1041 that is in is informative.
 
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