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?
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 […]
It has taken four years for the British to finally leave after their referendum against remaining in the European Union. Despite the last-minute trade deal, the impact of Brexit on the Pharma and Medtech industries is huge, and they are left with only a little concrete information. In 2016, just over half of the Britons […]
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In 2017, the European Commission launched the MDR and thus also the Unique Device Identification (UDI). Europe is not alone in this. The concern to make medical technology products safer is also being implemented in other countries. Corresponding initiatives are either being worked on or are in the planning phase. The WHO and other organizations […]
A single point of truth (SPOT) for data or document management is a must in highly regulated markets combined with increasing digitalization. Even small and mid-sized companies can hardly avoid this if they want to keep up with the market. Therefore, it is important to consider the advantages of a centralized data management system. There […]
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The medical device industry does not have much time left to implement the regulatory requirements of the Medical Device Regulation (MDR). By enforcing such complex regulations, there is a need for clarity on what´s meant by the various terms. Alone in the numerous provisions of the UDI regulations, many expressions need to be known. We […]