Dr Franziska Huber | Fieldfisher
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Professional background

Professional background

My main areas of practice

Our clients include national and international companies. My particular focus is on advising pharmaceutical companies and manufacturers of medical devices on regulatory matters. I also provide support in the negotiation and drafting of various types of contracts in the Life Sciences sector.

In addition, as part of the Life Science Regulatory Practice Group at Fieldfisher, I advise on market access, particularly with regard to reimbursement and pricing of medicinal products and medical devices in the inpatient and outpatient service sector of the SHI, including method assessment procedures before the G-BA as well as negotiations with statutory health insurance funds and the SHI-SV.

The regulatory advisory practice includes in particular the placing on the market of medicinal products and medical devices (conformity assessment procedures, marketing authorisation, distribution, GDP, contracts between actors in the supply chain), wholesale authorisations, compassionate use and single importation, clinical trials and good manufacturing practice.

I advise our clients in German and English.


Personal engagement  

I am involved as an editor at breakingthrough and am a member of the DJB.

I am a lecturer at the University of Augsburg for Pharmaceutical and Medical Device Law.

Education

Education

My background

I studied in Augsburg and worked there as the Managing Director of the Institute for Bio-, Health- and Medical Law at the University of Augsburg during my doctorate on a Medical Law topic.
After my legal clerkship, which included a stop in Washington D.C., I worked as a lawyer in an international law firm in the Life Sciences and Private Equity sector.
 
 

Authored pieces

All Resources
A digital representation of a DNA double helix, with glowing particles forming the iconic twisted ladder shape. The background is a gradient of blue and purple, giving a futuristic and scientific feel to the image.
Life Sciences and Healthcare
Insight

MDR-Reform: The Privileging of well-established technologies

07.07.2026
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A gloved scientist uses a pipette to add liquid to a 96-well plate in a laboratory. Scientific equipment and a computer screen displaying chemical formulas are visible in the background, highlighting a research environment.
Life Sciences
Insight

The EU Biotech Act: From Regulatory Reform to Business Action

24.06.2026
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Transparent bubbles of various sizes float against a gradient background transitioning from blue at the top to purple and pink at the bottom, creating an abstract and dreamy effect.
Insight

The Court of Justice of the European Union clarifies distributors’ duty of care under the Medical Devices Regulation: no separate conformity assessment required

23.06.2026
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A digital abstract image featuring a glowing blue particle wave flowing through a dark background. Below the wave, a network of interconnected points and lines creates a web-like structure, also illuminated in blue, giving a sense of data transmission and connectivity.
Insight

MDR Reform: Revised requirements for clinical evidence

15.06.2026
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Insight

New interface obligations for medical aids and implants in Germany

29.05.2026
Manufacturers of certain medical aids and implants (HiMi) should prepare for new interoperability obligations under the recently proposed revision of Section 374a SGB V (German Social Code V).
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