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...
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...
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...
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...
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...
After years of zoom meetings, it was great to see so many of you in real life. This year's conference was heavily focused on the Scan 4 Safety project, for which atrify provides the GDSN data pool. Healthcare in the UK is starting to move forward beyond COVID, but...
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...
After its consultation on the UDI regulation in the UK, the MHRA is now holding another consultation on the Clinical trial regulation to improve processes and simplify the activity of clinical trial sponsors. Its focus is particularly on "clinical trials and the...
Exchanging data with group purchasing organisations (GPOs) has long been cumbersome and time-consuming for healthcare producers. Each GPO had different requirements and different formats and attributes made the transfer of product data...
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...
The UK regulator MHRA has launched an official Consultation on their future UDI regulation due to close on 26th November 2021. The regulation is expected to enter into force in July 2023. The consultation itself is very thorough, looking at a number of options for...
The Chinese authorities have confirmed that all remaining Class III medical devices must be registered in the CUDID (NMPA UDI database) by 1 June 2022 - 8 months from now. atrify has been associated with the CUDID for years. The...
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,...
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,...
On 26th May 2021, the EU Medical Devices Regulation (MDR) finally came into full application, superseding the former medical device directives from the 1990's. EUDAMED has been live since December 2020 (Actor Registration module) and its 2 next modules (UDI and...
We are pleased to announce the new partnership between atrify and @GP. The French market will therefore benefit from the best of both solutions and expertise - atrify having built a successful connector to EUDAMED and other regulatory UDI databases in the world (for...
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.
Product information: What is it anyway? We all come into contact with product information almost every day, whether we are shopping in the supermarket, cooking or shopping online on the couch in the evening. And these are just a few examples of where we...
China's National Medical Product Administration (NMPA) today announced an extension of the deadline for high-risk devices until January 1, 2021, which originally would have expired on October 1, 2020 for Class III high-risk devices. In the short term, the NMPA announced the...
The Saudi Food and Drug Authority (Saudi FDA) has confirmed the deadlines for meeting the requirements by risk class for registration in its new UDI Regulation and UDI database. You can read the full declaration in English here. If...
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...
In June 2020, the GS1 Healthcare Global Trade Item Numer (GTIN) Allocation Rules were updated to improve their application rules, supply chain and point of care applications. Click here for the English Healthcare GTIN Allocation Rules...
As part of its involvement against the Covid-19, atrify is participating in a number of initiatives.
We are proud to announce that atrify is now an official GS1 Healthcare US Initiative Member! With this membership, atrify and its customers will now participate directly in shaping the future of the healthcare industry for the best outcomes for patients and the healthcare industry as a whole in the US and beyond.
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).
The GS1 DQX service and how atrify supports its suppliers in using the service "Data quality in the pool is poor" - this is an accusation that we at atrify have heard over and over again from our retail customers for many years. Get it right...
The European Commission formally announced on 25 March, that they request a 1 year delay for the MDR Date of Application (26 May 2021 instead of 2020); this measure is expected to adopted by the European institutions (European Parliament and Council of Ministers) by mid-April.
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.
Who doesn't know? After a long day at work, having to go to the supermarket for a short time, because your home refrigerator and pantry are yawning empty. In the store, the trained eye wanders through the shelves and next to the already for years proven and for...
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.
Our Director of Business Development, Mr. Lionel Tussau, was elected as Co-Chair of the MedTech Europe Eudamed IT experts AHWG. Congratulations Lionel! This is the result of your continuous commitment to Eudamed & MDR. We are sure that you have a...
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...