Authorised Representatives, Distributors, and importers appear to be the “Soup De Jour” for a lot of excellent industry blogs and articles. Lots of words are being written about their legal responsibilities and obligations, informing them of what they should be doing. I have read several of these articles and while they do a very good job of informing the affected companies of their legal obligations, what the European Commission has said, and the MDR regulations, I do feel they lack practical advice and solutions.
Here in EudaMed.com we really like practical solutions, we are less about lecturing and more about helping with tangible solutions. For example, when we were first speaking with MedTech companies about their MDR EUDAMED obligations, most companies did not understand us nor the complexity of MDR EUDAMED, so we came up with a solution. We created our exclusive MDR EUDAMED training courses, problem solved. Anybody who wants to understand MDR EUDAMED and does not have several weeks of their valuable time investing in research, now they come to our one-day training course, the solution.
Next MedTech companies were being told they had to collate all their data in preparation for MDR EUDAMED, but nobody offered practical solutions or even suggestions. EudaMed.com decided it was time for a real solution. Rather than simply paying lip service to a major industry issue, we worked on a solution. To put this effort in context, even with all of our MDR EUDAMED knowledge we still spent 175+ hours putting together the template solutions for MDR, IVDR, and legacy MDD devices, now the MedTech Industry has a practical solution, our templates. The EudaMed.com templates are available online for a price far lower than it would cost you to create yourself and with zero effort or stress.
Now we have the issue of the Authorised Representatives, Distributors, and Importers and their legal obligations. EudaMed.com had several requests from the industry asking if we would help develop a template solution. We did as requested we have come up with a template solution to assist the European Authorised Representatives, Distributors, and Importers, meet their legal obligations. The legal obligations include but are not limited to several registers, from device verification to complaint registers and many more, each of which these groups is legally obliged to keep. While the templates have some similar themes in the requirements, there remain some subtle differences between their obligations.
EudaMed.com using all their EUDAMED and MDR knowledge and experience has come up with the solution, we have created a template for each of the Authorised Representatives, Distributors, and importers. These templates are available now and will assist practically with their legal obligations.
If any group in the MedTech industry requires solutions for MDR/IVDR or MDR EUDAMED require solutions to a problem then please do contact us, we are always willing to help find real solutions.