EUDAMED improves transparency and coordination of information on medical devices. However, it often excels in its complexity. The main component of this complexity is its six modules, of which only three are released as of today. There is no release date scheduled for the remaining three modules yet. However, EU information materials are often difficult […]
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The In Vitro Diagnostics Regulation (IVDR) is often mentioned in the same breath as the Medical Device Regulation (MDR). Both regulations came into force on May 25, 2017, and both replace their respective predecessors: the MDR replaces the MDD, while the IVDR replaces the IVDD. A comparison of the regulations is not far off, as […]
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With an M2M interface to EUDAMED, manufacturers save time, reduce errors, and easily meet regulatory requirements. In this article, we highlight the key benefits and business case for M2M. Are there SaaS solutions for EUDAMED that offer integrated M2M? Of course, there are. They can provide a convenient way to load large amounts of data […]
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 […]
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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 […]
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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?