According to the Medical Device Regulation (MDR) and the In-vitro-Diagnostic Device Regulation (IVDR), EUDAMED’s Post-Market Surveillance refers to all activities in which data is proactively collected and information is gathered about products that are already on the market. The resulting information should be available in such a way that necessary corrective or preventive measurements can […]
On September 24, 2013, a directive was passed in the United States to introduce an identification system for MedTech products, which came into force on December 23 of the same year. It comes in the form of the Unique Device Identifier (UDI) and is intended to simplify the tracking of medical devices sold in the […]
Read More… from UDI Differences – Comparison between US and EU
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 […]
Read More… from Basics of the EUDAMED modules – What do I need to know?
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 […]
Read More… from IVDR Preparation – Why is it useful to start now?
Are there SaaS solutions for EUDAMED? Of course, there are. For example, they can provide a convenient way to load larger amounts of data into the EUDAMED UDI module via direct interfaces to the database (M2M), keep it up-to-date, and cover topics such as versioning, audit trail, or validation. There are various ways of exchanging […]
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 free Excel template for EUDAMED will help to simplify your work […]
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?