Meeting new demands

In 2021 was the MDD replaced by a new regulatory framework, the European union's Medical Device Regulation (MDR), which lead to significant changes in market access in the EUROPEAN union.

CL2017R0745SV0010030.0001_cp 1..1 (europe.eu)

CE-MARKING
That Molderm is approved for the nye the rules means that the product has passed the strict examination and control this regulation involves each of the producing company:
– claims
– scientific research
data and documentation in order to get a product approved in Europe.

This means that the control and safety in all stages from production, distribution and use to be verified by a third party (notified body is called Notified body & regulatory).

This also means that all the published text/marketing of the product must contain correct, and the EUROPEAN union-reviewed information in line with the reports that were reviewed by the registration of the CE marking. All the information you'll find on the molderm.com, and other channels operated by Molderm Aesthetics are in line with and performed in full compliance with, the Eu's nye directives.

Den største forskjellen for deg som behandler, før og nå, er at alt publisert materiale om produktet er en sammenstilling av fakta, data, rapporter og studier som er verifisert og gjennomgått av en uavhengig myndighet. Denne endringen i CE-merking er utviklet for å sikre kvaliteten og nøyaktigheten til både produkter og studier.

SUMMARY THE CE MARKING
CE-marking of products renewal with 3-5 year intervals.
All of the medical equipment within the EU fall under the nye the directive and as the CE-marking their ends, take the nye the regulation in force.

This objective and to investigate the CE marking provides transparency and security that the products keep it as is promised by the manufacturing company. Molderm is today (to date) the only HA filler on the market that have this nye the CE-marking.

PMS (POST MARKET STUDIES)
Molderm Aestethics follow continuously up all the results from the treatments carried out with the Molderm. The results you can follow on our website.
PMS is updated and appears transparent on the molderm.com.

PATENTED TECHNOLOGY
Molderm is based on the revolutionary and patented Fine-Tuning Technology™.
It means that scientific studies are submitted for review, testing and finally got approved the patent application.

The patent implies that there is only Molderm Aesthetics that will get to work with the technology that makes it possible to produce the product. This is a trade secret that is well guarded, but never silent.

IFU AND STUDIES
Molderm IFU (instructions for use), the folder which is included with the Molderm package, is manufactured in line with the nye the CE-marking. This means that the results from the studies and facts about the product are reviewed and approved by a “Notified body and the regulatory”.
In the folder you will find all the information except clinical trials.

Clinical studies commissioned by the manufacturing companies may be interesting, but unfortunately it seems it's most often as purchased materials. Our choice is to listen to you, your customers and your experiences and publish them consecutively on our website.