The European Commission regularly publishes documents to assist in the use of EUDAMED. Due to the complexity of EUDAMED as well as the multitude of instructional documents, it is nevertheless important to get an overview yourself. This way you will learn which aspects apply to your own company and your products. It is the only […]
The requirements of the EUDAMED and its six modules can quickly become confusing for its users, as can the maintenance of data. However, with the implementation date approaching, it is important to know how they will be implemented and which tools will help. Our Excel template for EUDAMED will help to simplify your work and […]
Besides the interaction of the individual EUDAMED modules and the assurance of data quality within the European database, versioning in EUDAMED is one of the main challenges. Different reasons can lead to changes in the product data already stored in EUDAMED. After updating the data, the new version is shown in EUDAMED, and the versioning […]
Read More… from Versioning of product data in the UDI module of EUDAMED
Whitepaper: The UDI module of EUDAMED – 10 tips about product data attributes Our whitepaper describes which data you have to store for your products in EUDAMED, respectively in the UDI module. We go into the differences between Basic UDI-DI and UDI-DI, explain the basic function of the UDI also apart from EUDAMED, briefly introduce […]
At the beginning of 2021, Brazil started to finally implement its UDI regulations. This is being done in stages with the involvement of various stakeholders. As with pharmaceuticals, Anvisa is the responsible authority. It is responsible for enacting the appropriate legislation, it reviews approvals for medical devices, and it monitors manufacturers’ quality management systems to […]
Read More… from UDI Resolution in Brazil: What needs to be considered?
The UDI regulations in Saudi Arabia are intended to play a role in health insurance and cost monitoring additionally to increase patient safety. However, the focus is on traceability, market surveillance, and various safety aspects. Authority: Kingdom of Saudi Arabia Food and Drug Administration (SFDA). Timeframe: The SFDA UDI regulation came into force by 01.08.2021. […]
ERP (Enterprise Resource Planning) systems offer MedTech manufacturers many options for controlling their processes and planning resources. However, they do not cover some use cases such as master data management, as is required in the industry to comply with the MDR. ERP systems offer numerous possibilities for companies to keep track of figures, data, and […]
Read More… from ERP for MedTech: Does Your ERP Cover Everything?
New regulations, such as the MDR and IVDR, not only provide the industry with opportunities like reorganizing and improving processes. The industry is confronted with several hurdles as well. Companies do not have to solve these on their own. Especially online, there is now a multitude of easily accessible and free resources that support companies […]
Read More… from MDR/IVDR: Which supportive initiatives are available?
In the context of the MDR, UDIs are an essential topic. After all, they not only have to be applied to the product and label itself. They also serve as a key for the EUDAMED and are part of the documentation. We have summarised all information on the different UDI types for you and defined […]
An important component of the MDR and IVDR is the EUDAMED. As a central database, it is intended to create more transparency, bundle information, and serve as an exchange and reporting platform for the individual actors. To this end, it consists of six modules that cover various topics ranging from the registration of medical devices […]