EUDAMED Blogs
Recap EUDAMED Online Session - MedTech Europe

Recap EUDAMED Online Session - MedTech Europe

I am honored to have been invited as a speaker for the MedTech Europe webinar on EUDAMED, which took place at the end of March. The webinar was organized specifically for the MedTech industry and had over 1,000 registered participants, a...

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EUDAMED - mandatory use in Finland!

EUDAMED - mandatory use in Finland!

We'd like to remind you that all medical devices sold in Finland must be registered in EUDAMED (UDI module) - whether new or "legacy devices" - since 2021; and the same will apply to IVD legacy devices by August 2022 already! With atrify, you can easily comply with...

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EUDAMED - From expertise to solution

EUDAMED - From expertise to solution

The EUDAMED UDI module for the registration of medical devices has been in operation since 4 October 2021 - voluntary from the point of view of the European regulation, mandatory or almost mandatory according to various European member states. Reminder: 5 years...

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Getting ready for EUDAMED go-live in September 2021

Getting ready for EUDAMED go-live in September 2021

EUDAMED, the key element of the Medical Device Directive (MDR) and In Vitro Diagnostics (IVDR) in the European Union, is expected to be released in modular form in the coming months. The so-called actor module will already be released in December 2020.

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EUDAMED Actor Registration Live

EUDAMED Actor Registration Live

atrify welcomes the production go-live of the EUDAMED Actor Registration module on 1st December 2020 This is a major milestone towards enabling manufacturers to be MDR and EUDAMED compliant, ahead of the production opening of UDI Device registration and Certificates...

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Data Integrity is Key for the Medical Device Industry

Data Integrity is Key for the Medical Device Industry

MDM West 2020 in Anaheim US wrapped up a few weeks ago and it was certainly an interesting and informative show. These companies that were present are critical links in the Medical Device supply chain providing a great assortment of specialized products and components.

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MDR/IVDR 2d Corrigenda adopted

MDR/IVDR 2d Corrigenda adopted

On 17th December the European Parliament adopted a second correction for MDR and IVDR. This mainly affects some Class I products, for which there is a four-year transitional period (until May 2024) for full transition to MDR...

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EUDAMED Test 2019 successfully passed

EUDAMED Test 2019 successfully passed

atrify has tested thousands of devices with 8 participating manufacturers in the first rounds of the EUDAMED tests (Playground 1 & 2). The EUDAMED UDI Playground has been available for three months to facilitate machine-to-machine and third-party data exchange.

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EUDAMED Data Dictionary

EUDAMED Data Dictionary

Manufacturers of medical products should put a big red ring around 26 March 2020 on their calendars. From this date all product data must be stored in the European database, EUDAMED. But how to go about it? Uploading data and maintaining it in the database...

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What is EUDAMED?

What is EUDAMED?

In 2017, the European Commission issued two new regulations: the regulation on medical devices 2017/745/EU (MDR), and the regulation on in vitro diagnostic medical devices 2017/746/EU (IVDR). The last 20 years have...

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MDR Deadlines Update

MDR Deadlines Update

The European Commission and the representatives of the member states have recently announced changes regarding the MDR deadlines: the latest deadline to register...

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