Certainly, the manufacturer may not
delegate the responsibility regarding labeling
@Peter Reijntjes, for the devices it places on the market. However, the manufacturer cannot be held accountable for the translations into other EU languages of devices that are made available on the market by distributors, importers or other legal persons. According to Article 16, if the distributor makes changes to labeling (including translation, per Article 16(2)(a)), then the distributor takes on these responsibilities inherent to the manufacturer and must have a QMS that covers those activities accordingly (Article 16(3)). Thus, it is possible to agree that the manufacturer places the device in e.g. the German market in German, and if the distributor wishes to make the device available in France, the distributor is responsible for the translation of the labeling and any additional instruction for use.
------------------------------
Juan Carriquiry
Altendorf
Switzerland
------------------------------
Original Message:
Sent: 27-Nov-2019 06:37
From: Peter Reijntjes
Subject: EU MDR, Chapter III, 23.1 gives the general requirements for information supplied by Manufacturer.
You cannot delegate a responsibility from a legal manufacturer to a distributor, the legal manufacturer always remains responsible for the translations. You can delegate the execution of the translations, yet have to have adequate controls over this outsourced process of translation, as defined in ISO 13485, clause 4.1.5. And under the MDR (Annex II.2) have a complete set of the labels and IFU's available in the Technical Documentation in the languages accepted in the Member States.
------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
Original Message:
Sent: 25-Nov-2019 08:57
From: Soumya Rajesh
Subject: EU MDR, Chapter III, 23.1 gives the general requirements for information supplied by Manufacturer.
Thank you all for such valuable feedback!
@Juan Carriquiry
The manufacturer is based in the EU (Netherlands) and has a contract with a distributor in the Netherlands who has multiple subsidiaries within the EU. In this framework, can the manufacturer maintain a parent contract with the distributor in Netherlands and then delegate the translation responsibility?
------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
Original Message:
Sent: 24-Nov-2019 11:06
From: Juan Carriquiry
Subject: EU MDR, Chapter III, 23.1 gives the general requirements for information supplied by Manufacturer.
I second here Dan O'Leary. You may chose to upload the IFU to fulfill this requirement, but updloading of the whole IFU is not a requirement in itself.
Also, note that as said the manufacturer is reponsible to provide the relevant information that accompanies the device (i.e. IFU), including the relevant language requirements of the member state where the manufacturer places such device. The distributor is responsible for verifying the labeling, including the fulfillment of language requirements. If the distributor or importer make availble the product in another member state different from the one the manufacturer placed it in, then they assume responsibility for the relevant translation.
------------------------------
Juan Carriquiry
Altendorf
Switzerland
Original Message:
Sent: 23-Nov-2019 10:57
From: Dan O'Leary
Subject: EU MDR, Chapter III, 23.1 gives the general requirements for information supplied by Manufacturer.
There are some distinctions here worth noting.
In Annex I(23.1), if your company has a website, then it must include, "the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate".
This requirement is not the whole IFU. A login portal is not mandatory. Because this information is available to users, you will need to translate it into the languages for the users as required by the Member States.
You may choose to offer the IFU in electronic, not paper, format, as long as you follow Regulation (EU) No 207/2012.
You have decided to offer the IFU in paper format, but not to translate all of it into the languages. I don't this is consistent with Art. 10(11), "Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient".
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 23-Nov-2019 07:58
From: Soumya Rajesh
Subject: EU MDR, Chapter III, 23.1 gives the general requirements for information supplied by Manufacturer.
Hi,
I am wondering if the IFU and operator manual must be on the manufacturer's website under the new MDR ?
The MDR states the following:
Annex I, Chapter III, paragraph 23.1: Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.
However, there is also this information: Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
Our device is intended for professional users Only. Hence based on our risk assessment, we have decided to provide translations only for key chapters and provide it in a booklet along with IFU in paper format with the device packaging. IFU is also made available in the device software.
I would like to know whether do we still need to put these documents on our company website? If yes, is a login portal for our customers/distributors Mandatory?
Thank you for your help!
------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------