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…
The importance of the EUDAMED packaging system for the regulation of medical devices in the EU The EUDAMED packaging system is an indispensable part of the broader EUDAMED system, which…
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 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 In the medical device industry, compliance with regulatory requirements is crucial for ensuring patient safety and product quality. One…
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…
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 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to EU and Swiss medical device manufacturers.As already mentioned in a previous article (MRA between Switzerland and EU no longer valid), Switzerland is considered as…
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…
Before jumping headfirst into the complexity of the Medical Device Regulation, you must be 100% sure that it is worth it. This assessment can be complex if you sell health-related…