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 runways in Entries help you find out, whether your product is regulated as a Medical Device, and what is its risk classification, according to the EU legislation. One runway takes you through the current Medical Device Directives, and the other through the new Regulations that will soon substitute the former.
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 brought to you one question at a time, with links and clause by clause references to those 30+ source documents whenever you need them.
You may go back and forth to explore alternative results and the Final Report summarises the rationale for your product. You’ll be as informed as anyone. In case of doubt with the result, you can turn to us or other experts 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.
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