ParisTommy
Starting to get Involved
Hello,
I would be interested in your professional opinions on the interpretation of Article 27
Does the UDI referred to in §7 refer to all the UDIs (UDI-DI+UDI-PI) for all lots made by the manufacturer, or does it just refer to the UDI-DI?
Article 27
Unique Device Identification system
§1.The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:
(a) production of a UDI that comprises the following:
(i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;
(ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;
(b) placing of the UDI on the label of the device or on its packaging;
(c) storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively; [...]
§3.Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.
Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.
§7.As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned.
At first I read §7 to be a list of all UDI-DI+UDI-PI (all the product refs, lots N° & dates etc...) because §1 seems to define the UDI as the UDI-DI+UDI-PI.
However, it says "as part of the technical documentation". It seems strange to me to have to keep a record of production lots placed on the market, in the technical file (in the QMS, I would expect companies to have a record of the batch files and traceability... but not necessarily a specific list of all the UDI-DI+UDI-PI assigned)
In §3 first indent, the UDI is referred to in relation to placing on the market, so therefore I read that as each time a new lot is released (so UDI-DI+UDI-PI), but in the second indent, it refers to checking that the information in EUDAMED is correct (according to Annex VI part B)… This information is just the UDI-DI, not the UDI-PI.
So I am confused what the legislators are expecting…
… Do they want an annual update of the medical device file with a list of the UDI-DI+UDI-PI?
… Do they just expect a list of UDI-DI’s to be placed in the Medical device file…?
Kind regards
Tom
I would be interested in your professional opinions on the interpretation of Article 27
Does the UDI referred to in §7 refer to all the UDIs (UDI-DI+UDI-PI) for all lots made by the manufacturer, or does it just refer to the UDI-DI?
Article 27
Unique Device Identification system
§1.The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:
(a) production of a UDI that comprises the following:
(i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;
(ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;
(b) placing of the UDI on the label of the device or on its packaging;
(c) storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively; [...]
§3.Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.
Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.
§7.As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned.
At first I read §7 to be a list of all UDI-DI+UDI-PI (all the product refs, lots N° & dates etc...) because §1 seems to define the UDI as the UDI-DI+UDI-PI.
However, it says "as part of the technical documentation". It seems strange to me to have to keep a record of production lots placed on the market, in the technical file (in the QMS, I would expect companies to have a record of the batch files and traceability... but not necessarily a specific list of all the UDI-DI+UDI-PI assigned)
In §3 first indent, the UDI is referred to in relation to placing on the market, so therefore I read that as each time a new lot is released (so UDI-DI+UDI-PI), but in the second indent, it refers to checking that the information in EUDAMED is correct (according to Annex VI part B)… This information is just the UDI-DI, not the UDI-PI.
So I am confused what the legislators are expecting…
… Do they want an annual update of the medical device file with a list of the UDI-DI+UDI-PI?
… Do they just expect a list of UDI-DI’s to be placed in the Medical device file…?
Kind regards
Tom
