atrify becomes 1WorldSync
At atrify, we always strive to offer our customers the best possible solutions. Following the acquisition by 1WorldSync, we have been thinking hard about our future strategy and would now like to share some significant news with you. Our goal has been to...
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 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...
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...
The European Union introduced the Medical Device Regulation (MDR) to improve patient safety and modernize public health. EUDAMED is a central EU database where information about medical devices is stored and...
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...
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...
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...
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...
We are pleased to announce that the partnership between GS1 Austria and atrify will be strengthened again. Especially manufacturers of medical devices located in Austria can benefit from the close cooperation between GS1 Austria and atrify. From now on, they have the...
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...
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...
Following the release of the Actor module, which has been operational since December 2020, the UDI and CERTIFICATE modules went live in EUDAMED on Monday 4 October. This is another important step towards the implementation of EUDAMED and the MDR/IVDR....
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,...
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...
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,...
There are a number of regulatory changes happening in healthcare right now that companies need to keep a close eye on - and we're here to help. Firstly, changes to the EUDAMED deadlines for the UDI and device registration module will make it easier for the industry to...
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...
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...
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.
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...
We are pleased to announce that ever since GridAgent joined atrify's Partner Program in 2019, our combined strengths have been enabling a growing number of Japanese customers to comply accurately and efficiently with global requirements in the healthcare 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.
atrifys success is built on working closely together with the community of manufacturers, their trading partners, regulatory bodies, and trade association. To further streamline this approach, we recently transformed our MDR Implementation task force into a regular UDI Regulatory user group.
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...
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.
Following the public announcement by the European Commission to postpone the launch of EUDAMED until May 2022, the CAMD Executive Group has prepared an open letter to express its concerns about this development. The CAMD Executive Group stresses that the...
Always 100 percent. A value that hovers above everything in healthcare. After all, human lives are at stake here. The regulations for manufacturers are therefore closely meshed, but also extremely complex. But anyone operating in this industry knows that in the end, the 100 percent...
The European Commission's EUDAMED M2M UDI test has been completed. With 1156 successful UDI transmissions we are the most successful participating connector. A big thank you to our customers, who have worked with us, and to our team - together we were able to...
The European Commission has appointed DEKRA Certification GmbH as IVDR Notified Body. This is a supplement to the previously named MDR Notified Bodies: BSI UK, TÜV Süd, DEKRADE, IMQ Italy and TÜV Rheinland. The Commission expects that by the end of this...
At the last meeting of the Member States with the EU Commission (MDCG Meeting 30 September) the following deadlines were confirmed: May 2020: Date for registration (EUDAMED database opening: March 2020) November 2020: Start of the most important registration...
Last week atrify carried out the first successful tests with EUDAMED. UDI data was uploaded, sent to EUDAMED and we received the positive confirmation message "success". The tests conducted by the European Commission...
The European Commission has designated five Notified Bodies: BSI UK, TÜV Süd, DEKRADE, IMQ Italy and TÜV Rheinland. The Commission expects to appoint a first IVDR Notified Body by the end of this year and to appoint between twelve and fifteen...
We are in the middle of the M2M test with the European Commission. Our first data sets have been successfully transferred to EUDAMED. The test period lasts until 14 October 2019, i.e. interested companies have two more weeks to participate in the test.
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...