UDI Resolution in Brazil: What needs to be considered?

UDI Anvisa Brazil

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…

UDI regulations in Saudi Arabia

UDI Regulation in Saudi Arabia

The UDI regulations in Saudi Arabia are intended to play a role in health insurance and cost monitoring additionally to increased 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. […]

Read More…

MedTech: Does Your ERP Cover Everything?

USPs of MDM system in comparison with ERP for Medical Technology companies

ERP systems offer medical device 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 (Enterprise Resource Planning) systems offer numerous possibilities for companies to keep track of figures, data, […]

Read More…

MDR/IVDR: Which supportive initiatives are available?

Do you need help understanding MDR/IVDR

New regulations, such as the MDR and IVDR, not only provide the industry with opportunities like reorganizing and imroving 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…

New Whitepaper: 7 Steps to UDI Compliance

Whitepaper: UDI Compliance MDR IVDR

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, but 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 […]

Read More…

The Six EUDAMED Modules (MDR)

Overview of the 6 EUDAMED modules (MDR)

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 […]

Read More…

The Brexit Impact on Pharma + MedTech Industry

What impact has the Brexit on the Pharma and MedTech Industry?

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 the 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 […]

Read More…

EUDAMED: Two More Years

An important component of Medical Device Regulation (MDR), the launch of EUDAMED, has been postponed by two years to May 2022. However, May 2020 remains the date for the other elements of the MDR. It was considered unlikely that the deadline for the MDR would be postponed. However, the European Union now announced that at […]

Read More…

In focus: UDI international

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 with corresponding initiatives or is in the planning phase. The WHO and other organizations have been working for […]

Read More…

Manufacturers must not lose sight of UDI

Just a year ago, an extension of the deadline for the implementation of the MDR was under discussion, which was desired above all by the manufacturers. The deadlines remained unchanged, which was quickly determined. However, the question of how to stem the upheaval in the medical technology industry remained unanswered. The biggest concern is probably […]

Read More…