Updating the website of the manufacturer

#1
Hi all

Am currently working on a labeling procedure and I would like a bit of help with this requirement on the paragraph d:

Article 18: Implant card and information to be supplied to the patient with an implanted device

1. The manufacturer of an implantable device shall provide together with the device the following:

(a) information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;
(b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;
(c) any information about the expected lifetime of the device and any necessary follow-up;
(d) any other information to ensure the safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a layperson and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.

What am not sure about is what constitutes updating the website information?
for example, after you have sold the device why would you want to update the device model, lot number or serial number?
 
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#2
I agree that the wording is confusing. The MDR seems to have a lot of confusing wording. Perhaps clarifications will be made in future revisions.

This is what all of this means:

The physical implant card to be given to the patient must include device identification, patient identification, health institute identification, device manufacturer identification, and manufacturer website. The patient also needs to be provided with information for safety, warnings, and information about device lifetime. This information may be provided through the website. When any information for safety, warnings, or device lifetime changes, the website is updated to reflect this info. This is so the patient always has access to updated info.

See also the guidance on implant cards: DocsRoom - European Commission
 
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