Control of Medical Device Marketing and Promotional Materials - EU regulation

[Jnks_Meddev]

Is there a verbiage somewhere (MDD or in MDR?) on the use of CE marks and requiring the Notified Body 4 digits afterward that could apply to promotional materials?

Also, I thought you can't have CE marked products marked in the same brochure as non-CE marked products. Can someone help me find the specific language on this?


Thanks!!

 

[Al Rosen]

I don't know if there is any specific language, but having CE marked and non CE marked products in the same brochure could be construed as misleading.

 

[Jnks_Meddev]

Thanks Rosen! I did some search on the forum and found the same question asked by someone else.
We cannot place the CE mark on a product catalog that contains non-CE marked products or items. If we have CE and non-CE marked product we can inform our notified body of our intent to place the CE mark products only on pages related to CE marked products. As you mentioned having a non-CE marked product on CE marked product page can be misleading.

 

[sarushka]

Hi ,
Has anybody here from Medical devices industry (not pharma) ever got cited by FDA ( on a 483 letter) for their misleading information on their marketing and promotional material? I want to know what level of RA/QA review and approval is required on these documents, some of our promotional and marketing material don't even have health-related claims on them , so I really don't think RA/Q review and approval is needed on such documents?
I appreciate your input. Thanks

 

[s27bax]

I think it’s worth mentioning here that there is now a requirement under Annex II 1.1 (I) for you to keep track of the location of device claims and technical specs where they are available to the user, e.g. brochure, website etc and something which I think will form a really useful document when it comes to implementing changes to claims or specs.

One of the few times I read the MDR and thought, what a great idea!

(l) technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.

 

[dgrainger]

One of the few times I read the MDR and thought, what a great idea!

(l) technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.

Annoyingly, that isn't echoed in the IVDMDR

 

[s27bax]

Funny that, you’d think team MDR and team IVDR would have talked to each other at some point

 

[sarushka]

I think it’s worth mentioning here that there is now a requirement under Annex II 1.1 (I) for you to keep track of the location of device claims and technical specs where they are available to the user, e.g. brochure, website etc and something which I think will form a really useful document when it comes to implementing changes to claims or specs.

One of the few times I read the MDR and thought, what a great idea!

(l) technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.

s27bax,

You brought up a really good point but how did you interpret from that annex that the location of such claims and specifications must be stored on a document? I understand that such claims and specification must be included in the technical documentation but wasn't sure if it also requires the manufacturer to keep track of the location of such claims.

Thanks,

 

[maya_tanase]

Thank you all for sharing your knowledge and insights on the topic. I was doing some research on the topic for a very specific claim:

• Could the "hypoallergenic" claim can be used for medical devices? (for instance, feminine sanitary products such as pads and tampons) If so, under which conditions?

This claim addressing skin compatibility of the product (e.g. ‘hypoallergenic’, ‘for sensitive or atopic skin’) is a cosmetics claim, but could it be used for a medical device as well?

The "REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on product claims made based on common criteria in the field of cosmetics" https://ec.europa.eu/transparency/regdoc/rep/1/2016/EN/1-2016-580-EN-F1-1.PDF
of 2016 concluded that:

"Most non-compliant claims were found to be misleading as regards the function and performance of the cosmetic product. Furthermore, as also mentioned in the difficulties faced by the national authorities whilst controlling claims on cosmetic products, it was not clear how to regulate the ‘hypoallergenic’ claim and the ‘free-from (an authorised ingredient)’ claim. Such a claim is considered to be denigrating as it is giving a negative impression to the consumer about an authorised and scientifically proven safe ingredient. All Member States that contributed to this report concurred that there is a need to clarify the ‘free from’ and ‘hypoallergenic’ claims. This could be done through the existing sub-working group on claims and ad hoc technical documents on the two issues."

Therefore, "hypoallergenic"could be considered misleading for a medical device as well.

However, I wasn't able to find any specific rules or guidelines for the advertising of medical devices, except for the MDR reference that Marcello mentioned in the previous posts. Article 7, "Claims" does leave room for a lot of interpretations...

I was wondering whether there is a list of terms that absolutely cannot be used (are deemed "not recommended"/"unacceptable") when advertising medical devices? I was able to find one for cosmetics ...

Any thoughts?

 

[dgrainger]

Hi,

Have a look at MEDDEV. 2.5/9 rev.1 - IMPLICATIONS OF THE MEDICAL DEVICES DIRECTIVES (93/42/EEC) IN RELATION TO MEDICAL DEVICES CONTAINING NATURAL RUBBER LATEX: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

P8 - "One implication of this is that terms implying minimal allergenic risk (e.g. hypoallergenic) are inappropriate. "​

P10: "For any medical device, the product labelling may not include:​

• any term suggesting relative safety, such as low allergenicity, hypoallergenic or low protein;​

• any unjustified indication of the presence of allergens"​