EUDAMED is the central information system developed by the European Commission to increase transparency and improve traceability of medical devices in the European Union. As the UDI module is already in production environment...
The impact of EUDAMED registration on supply chain management in the medical device industry
The introduction of EUDAMED has a significant impact on supply chain management in the medical device industry. However, these positive effects can only be optimized if they are combined with a strategy for exchanging product information with...
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...
Did you know that on average, manufacturers are missing 60% of the data required in EUDAMED?
We tell you how you can close this gap! In many gap analyses we have conducted, we have found that medical device manufacturers are missing on average about 60% of the data required by EUDAMED. This shows how important it is to...
The revision of the EU MDR: Beauty products now fall under the Medical Devices Regulation
The EU Medical Device Regulation (EU MDR) covers certain beauty products that were previously not considered medical devices. This means that these products must now meet the same safety and efficacy standards as conventional medical devices.The...
Deadline extensions for legacy products do not affect EUDAMED deadlines
On Dec. 9, the European Commission announced the extension of the validity period of certificates for legacy products on the European market. This has caused uncertainty and perplexity among some medical device manufacturers regarding the...
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...
GS1 Norway recommends atrify's UDI Solution for EUDAMED registration
Even if the mandatory registration of medical devices in EUDAMED still seems a long way off until 2023, many experts recommend already dealing with the complex requirements now and start testing and registering in time. GS1 Norway officially recommends using the...
"UDI and EUDAMED" session with Lionel Tussau at the Italian Regulatory Affairs Days Round Table
Lionel Tussau, the head of atrify Healthcare Market Unit, will participate in the round table organized by the Italian Trade Association Confindustria Dispositivi Medici during the Regulatory Affairs Days on 27th May (digital event), to share the expertise of the...
Why companies who went through atrify's Attribute Analysis have been successful
For the last few months, you have been the "happy" project leader for Eudamed! The one who inherited this project that nobody wanted... This topic has already put you in a cold sweat, just trying to get your famous SRN... Now that the UDI module is live (since last...
medical.device.forum of TÜV Süd: atrify gives tips on UDI registration in EUDAMED
Hosting a forum during a pandemic can be quite a challenge, especially when the participants are from the health sector. TÜV Süd, a notified body, has risen to the challenge and made the best of the...
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...
@GP and atrify - Joint Online Session for the French Community - 23.09.2021
As an ongoing effort to provide information on regulations, atrify hosts online sessions in multiple languages on EUDAMED, UDI regulations, and the exchange of product content between trading partners. @GP and atrify are hosting a joint online session "UDI, EUDAMED,...
Summer break - Welcome to the last UDI playground of EUDAMED
Healthcare manufacturers will have 1 more chance to participate in the EUDAMED playground for UDI & Device registration module which will be opened by the European Commission at the end of July and run during the month of August, enabling direct interaction with...
@GP and atrify - Joint Online Session for the French Community
As an ongoing effort to provide information on regulations, atrify hosts online sessions in multiple languages on EUDAMED, UDI regulations, and the exchange of product content between trading partners. @GP and atrify are hosting a joint online session "UDI, EUDAMED,...
EUDAMED - The countdown is on! Making the leap from GUDID to EUDAMED
EUDAMED is getting closer every day and testing is about to restart for the last UDI registration playground before going live in a couple of months. Time is getting short for companies to get their processes and UDI data in order. How to be compliant with the MDR...
Healthcare manufacturers are now able to reach French GPO Resah via GDSN
As a leading provider of product content solutions, we are pleased to announce that healthcare manufacturers are now able to send their data to Resah via the Global Data Synchronization Network (GDSN) for consolidated and reliable...
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.
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...
Getting compliant with China's UDI deadline of Oct 1, 2020 for high risk devices with atrify
Note of 30 September 2020: Extension of China's UDI deadline for Class III high-risk devices until 1 January 2021 Original contribution: Compliance with China's UDI deadline of 1 October 2020 for high-risk devices with atrify. The UDI registration requirements...
Message from the atrify Healthcare Industry GDSN User Group
Medical device manufacturers support the use of GS1 standards (GDSN) as the best process to exchange trusted product content with trading partners (group purchasing organizations and hospitals).
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.
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...
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.
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...
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...
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...