With the implementation of Two new Regulations i.e. Regulation (EU) 745/2017 European medical device regulation and Regulation (EU) 746/2017 European In Vitro diagnostic medical devices regulation, there are many new obligations that the manufacturer has to comply with and one of these is registration of devices on the UDI Portal of EUDAMED.
These regulations have introduced an identification system for medical devices based on Unique Device Identifiers – UDI.
The UDI system will promote easier traceability of devices and will considerably advance the post- market surveillance activities and allow better regulation of medical devices by the competent authorities.
The UDI is a series of alphanumeric characters which is designed to provide a globally accepted, single harmonized identification. It allows clear and distinct identification of a medical device.
UDI-DI: Device identifier, identification of a specific device model. It is the part of the UDI which does not change, and remains constant for the entire device group.
UDI-PI: Production identifier. It is made of lot number, serial number, expiry date, manufacturing date, software identification etc. This part will not remain constant.
Basic UDI-DI is intended to identify devices of the same group having the same intended purpose, risk classification and essential design characteristics and manufacturing process. It is the access key for the Eudamed database UDI Portal to access all the information related to the medical device.
The Basic UDI-DI will appear on the following:
The Basic UDI-DI does not appear on the packaging of a specific product. While the UDI-DI and UDI- PI will be placed on the device or device label and on the packaging of the medical device.
Here, UDI-DI is the number after the (01)
Then coming to UDI-PI part,
The UDI shall be placed on the device itself or the device label and on all higher levels of device packaging.
If there are space constraints on the device, device label or unit packaging, then the UDI shall be placed on the next higher packaging level.
The UDI must appear on the label in plain text or human readable information (HRI) and in form that uses Automated Identification for Data Capture (AIDC). The HRI consists of characters that can easily be read and interpreted by people.
If there is a space constraint which limits the use of both AIDC and HRI on the label, only the AIDC shall be placed on the label.
For devices which are to be used outside healthcare facilities, such as devices for home care, the HRI shall appear on the label even if there is limited space.
The European commission has designated GS1, HIBCC, and ICCBBA to issue UDI as mentioned in the MDR 2017/745 Article 27(2). The companies mentioned are already issuing UDI for US manufacturers.
On June 6th, 2019, a Commission Implementing Decision (EU) 2019/939 was issued. In the annex, a list of designated authorities is mentioned:
The Basic UDI-DI is the access key for device-related information in the Eudamed database.
The table below lists the timelines for registration of Basic UDI- DI on the EUDAMED database UDI Portal.
|Device as per Regulation (EU) 2017/745 (MDR)||Implantable and class III devices||Class IIa and IIb||Class I devices|
|Placing UDI-carriers on the labels of devices MDR Article 123(3)(f), Article 27(4)||26 May 2021||26 May 2023||26 May 2025|
|Direct marking of the reusable devices MDR Article 123(3)(g), Article 27(4)||26 May 2023||26 May 2025||26 May 2027|
|Device as per Regulation (EU) 2017/746 (IVDR)||Class D IVDs||Class C and B IVDs||Class A IVDs|
|Placing UDI-carriers on the labels of devices MDR Article 113(3)(e), Article 24(4)||26 May 2023||26 May 2025||26 May 2027|
Medical Devices, Active Implantable Medical Devices, and In Vitro Diagnostic Medical Devices that are covered under a valid CE certificate issued in accordance with MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC and that continue to be placed on market after the application of regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
Legacy Devices are subject to the MDR article 29 or IVDR Article 26 registration requirements with some exceptions of the assignment of a Basic UDI-DI and UDI-DI.
Still in order to comply with the standard structure and registration of devices in the EUDAMED, a EUDAMED DI- equivalent to Basic UDI-DI will be required and an EUDAMED ID will be generated from it.
Now let’s suppose, if the manufacturer does not have UDI-DI for a Legacy Device, the manufacturer has to assign a EUDAMED DI and EUDAMED ID.
The EUDAMED DI will have a standard format, starting with prefix ‘B-‘ and continuing with a set of 25 characters.
The best practice is to include the SRN of the manufacturer as the unique identifier for generating the EUDAMED DI.
Manufacturer SRN: IN-MF-000000111
Product Code: BRQ12345
There are many variatns of passages the majority have suffered alteration in some foor randomised words believable.
The UDI system applies to all the devices except for custom- made devices and performance study/ investigational devices.
Software as a medical device shall be subjected to UDI rules.
The UDI carrier for reusable devices that require disinfection, sterilisation or refurbishing between patient uses shall be permanent and legible after each process performed throughout the intended lifetime of the device. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the (reusable) device.