Diapharm has obtained the first MDR certificate risk class III


Diapharm has obtained the first MDR certificate risk class III

The Regulation (EU) 2017/745 for medical devices - MDR - applying since May 21, 2021 requires changes, corrections and additions with the proof of the General Safety and Performance Requirements as well as the quality management processes.

The manufacturers are facing enormous challenges, costs and risks!
With expiring Declarations of Conformity and ending certificates, they risk the complete loss of their products.

Furthermore, the substantial ambiguity when interpreting the MDR - for example regarding the guidance MDCG 2022-05 on borderline issues with respect to medical devices and medicinal products, published in April 2022 - makes the definition, structuring and accomplishment of a successful certification more difficult.

The reclassification of many medical devices into higher risk classes as required in the MDR, includes the involvement of a Notified Body. The willingness of the Notified Bodies, however, to accept new customers is currently very limited; the requests of numerous companies are waiting to be processed!

HÄLSA Pharma GmbH, a Diapharm subsidiary, succeeded in overcoming all these difficulties. In July 2022, HÄLSA received the first MDR certificate for a substance-based medical device of the risk class III.

Based on that, HÄLSA is now preparing further MDR certifications.
This includes substance-based medical devices of the risk classes IIa, IIb and III as well as applicators, which are supplied with a medicinal product or form a single integral product with it.

Since 2005, HÄLSA adopts the responsibility as a manufacturer on behalf of numerous enterprises with more than 100 medical devices of all risk classes.

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