Table of Contents
If you want to learn in details and understand the new Track & Trace requirements regarding medical devices – this is your event!
Medical Devices Regulation (MDR) is a real hot topic amongst the supply chain participants. It completely changes the legislation and business processes regarding the production and distribution of medical devices.
SoftGroup knows that the transition could be full of “moving pieces” – do not take the risk, join the webinar and found out everything that you should take into account!
Get the whole picture and find the answers now!
Date: 23 November 2021
Working language: English
What did you learn about:
- MDR- Regulatory Framework & Requirements
- UDI – Specifics & Requirements
- EUDAMED – structure & modules
- Challenges & Benefits
- Future of medical devices
What did you ask us?
Where is the exact place of generating serial numbers?
The exact place of generating the serial numbers in production could be done on your serialization machine or could be done in additional software solution in case that you have more than 2 lines Afterwards you have to report this serial number to the Regulatory system, in this case for Medical Devices – EUDAMED.
What are the different Actor roles for Economic Operators in EUDAMED and how they register in EUDAMED?
The different Actors for Economic Operators involved in EUDAMED are:
- System and procedure pack producers
- Authorized representatives
The actor registration request for any manufacturer, authorized representative, importer or a system/procedure pack producer should be verified and approved by a competent authority.
There are 2 ways to register in EUDAMED as Economic operator:
– economic operator except non-EU manufacturers
If you are officially registered (‘established’) in the EU, your details will be assessed by the competent authority in that country.
– economic operator non-EU manufacturers
If you are not registered in the EU, you must, when registering in EUDAMED, identify your registered authorized representative on EU territory.
In the case of already existing certificate, do I have to reinstate it or to generate a new one?
When you have already a certificate, you do not need to recertificate now. You have a transition period by May, 2024. Now you can continue to manufacture and sell your medical devices with the current certificate that you have. You just need to go to EUDAMED and register. After that you can continue your business before May 2024. Then, in the beginning of 2024 you need to participate and get a new certificate from EUDAMED.
Go to Webinar`s Recording
The video is available on-demand HERE