Basic UDI-DI: what is it, where does it come from, why do you need it?

Basic UDI-DI: what is it, where does it come from, why do you need it?

Basic UDI-DI: what is it, where does it come from, why do you need it?

With the advent of new European regulations governing the circulation of medical devices in the European Union, a number of requirements have arisen that manufacturers must comply with if they want to sell their medical products in Europe. One of these requirements is the basic UDI-DI. Let's look at what basic UDI-DI is, how to get it, and how it should then be used.

What is basic UDI-DI

The basic UDI-DI is one of the new requirements of the European medical device and in vitro medical device regulations, imposed by MDR 2017/745 and IVDR 2017/746. The need to obtain and use the basic UDI-DI is regulated by Article 29 of the MDR and Article 26 of the IVDR. According to these articles, every manufacturer of medical devices or in vitro diagnostic devices is required to obtain a basic UDI-DI in order to legally sell their products in the EU.

Регистрация в EUDAMED

Need EC REP or PRRC for the EU?

Contact us right now:

+49 176 67510274

info@mdrc-consulting.com

For more detailed requirements regarding basic UDI-DI, see Part C of Annex VI of the MDR and Part C of Annex VI of the IVDR. For even more detailed information, please refer to the MDCG Guidance 2018-1.

Essentially, a basic UDI-DI is a unique identifier that refers to a separate group of products from the same manufacturer. Basic UDI-DI should not be confused with the UDI-DI identifier (without the word "basic" at the beginning).

UDI-DI is a code used to identify individual medical products or individual packages of these products. The UDI-DI system has been in use in the US for some time, and has recently (since the entry into force of the MDR and IVDR) been introduced in the European Union. It is important to understand that UDI-DI and basic UDI-DI are different identifiers and are used for different purposes. Basic UDI-DI is unique for Europe.

UDI-DI и basic UDI-DI
UDI-DI и basic UDI-DI

How to get basic UDI-DI

According to the MDR, there are several special issuing entities that are accredited by the European Union to issue basic UDI-DI. The European Commission has accredited four such organizations:

  • GS1
  • HIBCC (Health Industry Business Communications Council)
  • ICCBBA
  • IFA GmbH

In order to obtain a basic UDI-DI, it is necessary to use encryption standards developed by one of these an issuing entities. To do this, you must contact one of the organizations.

How Basic UDI-DI Works

The basic UDI-DI is an alphanumeric code consisting of several parts. Let's have a look at a basic UDI-DI using the example of the identifier compiled based on GS1 standards.

Basic UDI-DI
Basic UDI-DI

The first part of the GS1 basic UDI-DI is the company prefix that GS1 issues when registering a company electronically. What follows is a code that the manufacturer assigns to the product group using their own internal standards. The last two characters of basic UDI-DI are generated using a special calculator designed to create and verify basic UDI-DIs.

How to group products

The basic UDI-DI is not assigned to individual products, but to groups of products that are united by certain characteristics. Thus, for the assignment of basic UDI-DI, it is necessary first of all to group the products - each group will receive its own identifier. Product grouping is the task of the manufacturer.

Products can be grouped together, if they:

  • Have the same intended use
  • Fall into one risk class
  • Have a similar design
  • Have similar characteristics

How basic UDI-DI is used

The basic UDI-DI is an important part of product and manufacturer documentation. It appears:

  • In manufacturer's certificates issued by notified bodies
  • In the EU Declaration of Conformity
  • In the technical documentation
  • In certificates of free sale

In addition, the basic UDI-DI is used when registering products in the EUDAMED system, as well as when interacting with notified bodies.

We are here to help you place your medical devices on your strategic markets.

+49 176 67510274

info@mdrc-consulting.com

With the advent of new European regulations governing the circulation of medical devices in the European Union, a number of requirements have arisen that manufacturers must comply with if they want to sell their medical products in Europe. One of these requirements is the basic UDI-DI. Let's look at what basic UDI-DI is, how to get it, and how it should then be used.

What is basic UDI-DI

The basic UDI-DI is one of the new requirements of the European medical device and in vitro medical device regulations, imposed by MDR 2017/745 and IVDR 2017/746. The need to obtain and use the basic UDI-DI is regulated by Article 29 of the MDR and Article 26 of the IVDR. According to these articles, every manufacturer of medical devices or in vitro diagnostic devices is required to obtain a basic UDI-DI in order to legally sell their products in the EU.

Регистрация в EUDAMED

Need EC REP or PRRC for the EU?

Contact us right now:

+49 176 67510274

info@mdrc-consulting.com

For more detailed requirements regarding basic UDI-DI, see Part C of Annex VI of the MDR and Part C of Annex VI of the IVDR. For even more detailed information, please refer to the MDCG Guidance 2018-1.

Essentially, a basic UDI-DI is a unique identifier that refers to a separate group of products from the same manufacturer. Basic UDI-DI should not be confused with the UDI-DI identifier (without the word "basic" at the beginning).

UDI-DI is a code used to identify individual medical products or individual packages of these products. The UDI-DI system has been in use in the US for some time, and has recently (since the entry into force of the MDR and IVDR) been introduced in the European Union. It is important to understand that UDI-DI and basic UDI-DI are different identifiers and are used for different purposes. Basic UDI-DI is unique for Europe.

UDI-DI и basic UDI-DI
UDI-DI и basic UDI-DI

How to get basic UDI-DI

According to the MDR, there are several special issuing entities that are accredited by the European Union to issue basic UDI-DI. The European Commission has accredited four such organizations:

  • GS1
  • HIBCC (Health Industry Business Communications Council)
  • ICCBBA
  • IFA GmbH

In order to obtain a basic UDI-DI, it is necessary to use encryption standards developed by one of these an issuing entities. To do this, you must contact one of the organizations.

How Basic UDI-DI Works

The basic UDI-DI is an alphanumeric code consisting of several parts. Let's have a look at a basic UDI-DI using the example of the identifier compiled based on GS1 standards.

Basic UDI-DI
Basic UDI-DI

The first part of the GS1 basic UDI-DI is the company prefix that GS1 issues when registering a company electronically. What follows is a code that the manufacturer assigns to the product group using their own internal standards. The last two characters of basic UDI-DI are generated using a special calculator designed to create and verify basic UDI-DIs.

How to group products

The basic UDI-DI is not assigned to individual products, but to groups of products that are united by certain characteristics. Thus, for the assignment of basic UDI-DI, it is necessary first of all to group the products - each group will receive its own identifier. Product grouping is the task of the manufacturer.

Products can be grouped together, if they:

  • Have the same intended use
  • Fall into one risk class
  • Have a similar design
  • Have similar characteristics

How basic UDI-DI is used

The basic UDI-DI is an important part of product and manufacturer documentation. It appears:

  • In manufacturer's certificates issued by notified bodies
  • In the EU Declaration of Conformity
  • In the technical documentation
  • In certificates of free sale

In addition, the basic UDI-DI is used when registering products in the EUDAMED system, as well as when interacting with notified bodies.


We are here to help you place your medical devices on your strategic markets.

+49 176 67510274

info@mdrc-consulting.com


CONTACT US

whether you have a question about our solutions or need help with your new project

    Contact us whether you have a question about our solutions or need help with your new project