EMDN codes in EUDAMED: functionality and use
The European Database for Medical Devices (EUDAMED) plays a crucial role in the regulation and surveillance of medical devices within the European Union. With the introduction of the regulations (Art.…
Category Technical article
FDA warns manufacturers about GUDID data discrepancies
The U.S. Food and Drug Administration (FDA) has taken a proactive step to ensure the accuracy and compliance of medical device information by notifying medical device manufacturers of potential discrepancies…
The importance and implementation of critical warnings in the EUDAMED
Critical warnings: Essential aspects and their significance The evolving world of medical devices is subject to complex regulations designed to ensure the safety and effectiveness of healthcare products. With the…
Swiss UDI Requirement – Everything you need to know
SWISSDAMED - The swiss UDI database The Mutual Recognition Agreement (MRA), one of the main agreements between the EU and Switzerland facilitating bilateral trade in a number of key sectors…
Streamlining Compliance: OPAL & Europe IT Consulting
Streamlining Compliance: OPAL Labelmanagement & Europe IT Consulting => Perfect Pair for UDI and Labeling As medical device manufacturers prepare to comply with the EU Medical Device Regulation (MDR), one…
Understanding Eudamed, UDI, and MDR: A Guide for Medical Device Manufacturers
Understanding Eudamed, UDI, and MDR: A Guide for Medical Device Manufacturers In the medical device industry, compliance with regulatory requirements is crucial for ensuring patient safety and product quality. One…
UDI overview in Asia
Marked by strong economic development, Asian countries are gradually implementing UDI and regularizing their regulatory environment for medical devices. It is therefore smart to know where these countries are in…
Details on Storage/Handling conditions and Critical warnings
Which details of the critical warnings have to be provided to EUDAMED, to the GUDID ? The Label information, the instructions for use, or both ? What about the contra…
New requirements for Switzerland
New differing requirements now apply to EU and Swiss medical device manufacturers.As already mentioned in a previous article (MRA between Switzerland and EU no longer valid), Switzerland is considered as…
New nomenclature for EUDAMED: EMDN
With the implementation of the Medical Device Regulation comes the new EMDN (European Medical Device Nomenclature), as stated in the regulations (Art.26 2017/745 MDR, Art.23 2017/746 IVDR). Review this concept…