Do you need to know if your product is considered a Medical Device in the European marketplace?
Do you need to find out the European risk class for your device?
This service will save you lots of time and effort!
The first regulatory runways in Entries take you through qualification and classification of a Medical Device in a matter of minutes. More specifically, they help you in finding out if your product is regulated as a Medical Device in EU, and in guiding you towards the correct risk classification according to the current medical device directives and the new regulations: the MDR and the IVDR.
Traditionally this task is performed by flipping through the pile of legislation and guidance documents provided by the European Commission, namely the MEDDEV’s, the Borderline Manual, etc. In Entries this same information is re-organized into minute runways with complete references and links to those source documents for your convenience.
You may go back and forth to explore alternative results and fine tune the intended purpose of your product while browsing. You will leave with a fully referenced rationale for your device as the Final Report. In case of doubt with the result, you can turn to us, other experts or the authorities for further discussion.
Even though qualification or classification of Medical Devices is not in your focus, Entries may eventually bring you other time saving benefits.
The first regulatory runways in Entries focus on the qualification and classification of Medical Devices according to the EU legislation. We will introduce more runways on the Entries platform in collaboration with our Partners. Therefore, we welcome you to get acquainted with our services and to get in touch with us, whatever your needs may be. We might be able to help you.
If you are interested in collaboration, just pick up the phone.
By using Entries, we were able to classify our device in only a moment and print out a fully referenced rationale for our records and for discussions with the authorities. We give credit to the intuitive service concept and hope this is only the beginning of a series.
The service is surely a great help for a company like Innokas Medical, as we work in close collaboration with our clients to help them to design, develop and manufacture regulated medical devices. One still needs to interpret the information from the point of view of the intended use of a specific device, of course, but it does help a lot to have a tool where this information is structured into a path.
- Tiina Kotipalo, Head of QA/RA, Innokas Medical
We have been using Lean Entries’ service for about six months. The platform helped us to assess and cross check the classification of various medical devices. It was a useful source to support our daily business and saved us time and – as a result – money.
- Michael Sander, VP Sales & Marketing and Martina Sander-Giesemann, VP Operations, mdi Europa GmbH