Fieldfisher

Life Sciences Regulatory

Dr Cord Willhöft, LL.M. (KCL) is a Partner in Fieldfisher's Munich office and advises medical device manufacturers and pharmaceutical companies on sector-specific matters, in particular Regulatory, Healthcare Compliance and reimbursement in SHI.

His regulatory expertise covers the placing on the market of medical devices and medicinal products, including clinical evaluation and testing, conformity assessment procedures and authorisation, making available on the market, MDR compliance of economic operators, as well as the representation of companies' interests vis-à-vis authorities and courts.

The area of Healthcare Compliance includes the legally compliant design of cooperation with healthcare professionals and patient organisations, as well as product-related sales promotion.

He is a leading expert in the area of SHI reimbursement of medical devices in the outpatient and inpatient service area of SHI.

In particular, we advise companies on medical device method assessment procedures (§ 137h SGB V) and testing procedures (§ 137e SGB V).

We have advised numerous (US) companies on the implementation of MDR requirements, including ZOLL Medical Co, Asahi Kasei Medical, Starkey, Galvanize Therapeutics, Pulmonx, Saluda Medical, Procept, Corvia Medical, Route 92, Intersect ENT and ResMed.

He gets recommandations from JUVE and Legal 500.

He advises his clients in German and English.

He is a regular speaker, gives trainings in companies and is also involved in local sports clubs (Münchener Ruderclub von 1880).

He regularly publishes in relevant journals and is, among other things, co-author of the medical devices law commentary Lücker/Baumann.