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Meeting new demands
In 2021, the MDD was replaced by a new regulatory framework, the EU’s Medical Device Regulation (MDR), which brings significant changes to market access within the EU.
CL2017R0745SV0010030.0001_cp 1..1 (europa.eu)
The fact that Molderm is approved according to the new rules means that the product has passed the rigorous examination and control this regulation entails of each producing company:
– scientific research
– data and documentation to get a product approved in Europe.
This means that control and safety at all stages from manufacturing, distribution, and use are verified by a third party (the control body is called Notified body & regulatory).
This also means that all published text/marketing about the product must include correct, and EU-reviewed, information in line with the reports that were reviewed when registering the CE marking. All the information you find on molderm.com, and other channels operated by Molderm Aesthetics are in line with and carried out in full compliance with, the EU’s new directives.
The biggest difference for you as a processor, before and now, is that all published material about the product is a compilation of facts, data, reports, and studies that have been verified and reviewed by an independent authority. This change in CE marking has been developed to ensure the quality and accuracy of both products and studies.
SUMMARY CE MARKING
CE marking of products is renewed at 3-5 year intervals.
All medical devices within the EU fall under the new directive and as their CE markings expire, the new regulation takes effect.
This objective and scrutinizing CE marking provides transparency and security that products keep what is promised by manufacturing companies. Molderm is today (to date) the only HA filler on the market that has this new CE marking.
PMS (POST MARKET STUDIES)
Molderm Aestethics continuously follows up on all results from treatments performed with Molderm. You can follow the results on our website.
The PMS is updated and displayed transparently on molderm.com.
Molderm is based on the revolutionizing and patented Fine-Tuning Technology™.
This means that scientific studies have been submitted for review, testing and finally received approval of the patent application.
The patent means that only Molderm Aesthetics is allowed to work with the technology that makes it possible to manufacture the product. This is a trade secret that is well guarded, but never quiet.
IFU AND STUDIES
Molderm IFU (instruction for use), the folder included in the Molderm package, is produced in line with the new CE marking. This means that results from studies and facts about the product have been reviewed and approved by Notified body and regulatory.
In the folder you will find all information except clinical studies.
Clinical studies commissioned by manufacturing companies can be interesting, but unfortunately, most often seem like purchased material. Our choice is to listen to you, your customers, and your experiences and publish them continuously on our website.
Molderm® is distributed via and ONLY by an exclusive distribution network to ensure the same quality and identity, shared values and concept, no matter where you are located. You only have the opportunity to order your Molderm® products from the distributor who is responsible for the territory you are located in. Click on “see distributor list” down below to find your distributor.
Interested in getting exclusive distribution rights of Molderm® in your country? Please click on “become a distributor” for application and initial contact.