MDSSAR News & Events

2023-02-24T00:00:00+01:00

It's time for EUDAMED!

National Authorities improve their vigilance systems, but that is far from harmonization.

It makes the system even more complicated if every authority creates their own reporting system. Such changes don’t make it easier to keep EU and non-EU manufacturers selling their devices in Europe.

See the new e-service for vigilance submissions for Sweden. This website should be used for submissions until EUDAMED is mandatory for vigilance. No registration is required.

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

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Categories: News

Tags: EU EUDAMED

2023-02-23T00:00:00+01:00

New Features and Improvements in EUDAMED Production v 2.10

EUDAMED Production v 2.10 has been released with several new features and improvements.

Are you ready for the latest and greatest version of EUDAMED Production? Look no further than version 2.10, which comes with a range of exciting new features and improvements. In this post, we'll provide you with a brief overview of what's new, including updates to the Actors module, UDI/Device module, NB & Certificates module, and DTX.

One of the key features in the Actors module is the ability to set an Economic Operator as inactive, which creates a new version of the Economic Operator with the new status. The UDI/Device module now allows you to search for devices by indicating the Competent Authority (CA) responsible for the manufacturer, while the NB & Certificates module lets you register refused certificates, refused applications, and withdrawn applications of type product.

In addition to these exciting new features, EUDAMED Production v 2.10 also includes several user experience and user interface improvements, various fixes, and updates to the DTX. So if you want to operate more efficiently in EUDAMED, be sure to upgrade to the latest version today. Read the full document here.

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

Categories: News

Tags: MDR EUDAMED IVDR European Commission

2022-07-29T07:00:00+02:00

EUDAMED registration

1. Obtain the Actor ID / SRN

The economic operator will obtain a unique Actor ID/SRN for each actor role. If the economic operator has multiple roles, separated registration requests are required in order to obtain a different and specific Actor ID/SRN for each actor role.

What is an Actor ID / SRN ?

The Actor ID/SRN (Single Registration Number) uniquely identifies every economic operator in EUDAMED. The Actor ID/SRN is issued once the relevant competent authority has validated the Actor registration request.

If the economic operator has multiple roles, separated registration requests are required in order to obtain a different and specific Actor ID/SRN for each actor role.

2. Validation Process

The economic operator submits an actor registration request in EUDAMED.
For non-EU manufacturers, its authorised representative verifies the registration
request before passing it to the national competent authority for assessment.

Keep in mind that information provided during the Actor registration has to match with the signed Mandate with the authorised representative.

The national competent authority issues the Actor ID/SRN (generated by EUDAMED)
after approving the registration request.

EUDAMED notifies the Actor ID/SRN via email to the economic operator.

MDSS requires with the actor registration in Eudamed that the MDR Mandate is being executed with MDSS and that MDSS has received the Mandate according to the MDR.

Get yourself registered

Categories: News

Tags: EUDAMED