Regulatory Open Forum

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/

Hi again,

For clarity, I spoke with the European Commission yesterday and I put this question to them:

For EUDAMED are self-declared IVDD devices treated any differently than other legacy devices? Or do they just register in EUDAMED the same way as any other legacy device? 

They responded:

There is no difference.

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/

Hi again,

For clarity, I spoke with the European Commission yesterday and I put this question to them:

For EUDAMED are self-declared IVDD devices treated any differently than other legacy devices? Or do they just register in EUDAMED the same way as any other legacy device? 

They responded:

There is no difference.

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/

Hi again,

For clarity, I spoke with the European Commission yesterday and I put this question to them:

For EUDAMED are self-declared IVDD devices treated any differently than other legacy devices? Or do they just register in EUDAMED the same way as any other legacy device? 

They responded:

There is no difference.

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/

Hi,

You are very welcome. Concerning the EUDAMED support, I have major doubts about the quality of the information they are providing. I do not think they are being trained in all things EUDAMED which is another reason why we are offering support to companies.

Your screenshot looks accurate to me.

Good luck with EUDAMED.

Hi again,

For clarity, I spoke with the European Commission yesterday and I put this question to them:

For EUDAMED are self-declared IVDD devices treated any differently than other legacy devices? Or do they just register in EUDAMED the same way as any other legacy device? 

They responded:

There is no difference.

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/

Hi,

You are very welcome. Concerning the EUDAMED support, I have major doubts about the quality of the information they are providing. I do not think they are being trained in all things EUDAMED which is another reason why we are offering support to companies.

Your screenshot looks accurate to me.

Good luck with EUDAMED.

Hi again,

For clarity, I spoke with the European Commission yesterday and I put this question to them:

For EUDAMED are self-declared IVDD devices treated any differently than other legacy devices? Or do they just register in EUDAMED the same way as any other legacy device? 

They responded:

There is no difference.

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/

Hi,

You can upload legacy devices with an existing UDI DI from one of the four designated issuing entities.

If you already have a real UDI DI then you can use this with the issuing entity, then for the Basic UDI you take the existing UDI DI and add a 'B-' in front of it with EUDAMED as the issuing entity. This way when you upload your IVDR/MDR devices you reuse the same UDI DI and EUDAMED creates a link between the two thus preserving your device history. If you are entering your data via the EUDAMED forms you enter your real UDI DI and press the generate button and it adds the B-. However, if you are submitting XML you must prepare this data yourself with the 'B-'.

If you do not have an existing UDI DI from one of the four designated issuing entities then you need to generate the B-UDI etc. You effectively need to generate a fake Basic UDI and UDI DI whose only purpose is to get your data into EUDAMED. It never appears on labels etc. If you are adding your data via the EUDAMED forms you follow the instructions and click the "Generate" button OR you can pre-generate your own codes following a very long algorithm from the European Commission, when using XML you must pre-generate the B-UDI/UDI DI, again this is only if you do not have an existing UDI DI. To save you a lot of trouble with this generation of codes we prepare an excel template where you can create as many as you like. This template is available for free: https://eudamed.com/index.php/eudamed-legacy-device-di-generator/