"New" MDR implant card for absorbable substances

[Wolf.K]

Hi,

A friend of mine asked me if I already read the new MDR (yes) and if I noticed chapter 18 ("Implant card and information to be supplied to the patient with an implanted device". As he works for a company which manufactures hemostats and adhesion prevention products (like oxidized cellulose products) he has products class III, implants for transient, short or long term duration of use - depending how fast the substances are absorbed by the body. Some within days, some can still be found after more then 30 days (if the doctor put too much into the patient).

We both read the above mentioned article 18, also definition # 5 "implantable device", and now we wonder: to be MDR complient, does he has to add implant cards to each small bellows bottle of powder or each sheet of cellulose??

Until now, this was not a requirement, only for certain implants (like metal hip joint replacements, heart pace makers and so on).

Article 18 states a lot.
(1) The manufacturer of an implantable device shall provide together with the device the following... (a)(information e.g. serial number)... to (d)...

"In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device".

(2)"...together with the implant card, which shall bear their identity".

(3) The following implants shall be exempted from the obligations... sutures, staples, dental fillings and else

So, how shall we interprete this article 18???

 

[Pads38]

re: "New" MDR implant card for absorbable substances

I would suggest that your 'temporary' implants would fall into the excluded list.

The purpose of an Implant Card is to provide the patient with clear identification of their implant and any precautions that they need to be aware of going into the longer term. (MRI safety, airport scanners).

Where the implant is absorbed this would be largely irrelevant.

 

[dgrainger]

Unless the devices mentioned are in the list, then yes a card will be required.

 

[Wolf.K]

Yes, for absorbable substances an implant card seems a bit strange, but the text of the MDR might include some mistakes, right?

I wonder where he could get "official" information on this issue?

 

[Sulamistan]

The following point in the MDR sheds some light, although not strictly applicable to your case, it is addressing a similar conundrum.

Page 2, para 8

It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant.

So I guess, you might need to check with the CA of member state where you plan to sell the product.

 

[Wolf.K]

I found this leaflet published by the Australian Therapeutic Goods Administration:
https://www.tga.gov.au/sites/defaul...opean-medical-device-regulatory-framework.pdf

Australia is planning to align their regulation with the new European regulation. The leaflet is about implantable meshes, which are now all classified as class III, and they now need a patient implant card.

Therefore, I guess, all implantable devices will need an implant card, including hemostats (if left in the body and absorbed), tissue glues, adhesion prevention products, and else.

 

[Wolf.K]

Here is the list of the Submissions received for "Alignment with European medical device regulatory framework: Strengthening the assessment of medical devices and information for consumers Up-classification of surgical mesh & Patient implant cards"

Submissions received: Alignment with European medical device regulatory framework | Therapeutic Goods Administration (TGA)

If I understand it correctly, all people just thought that they are just considering implantable meshes, right?