Medical devices

The legal field of medical devices has been subject to continuous and comprehensive change for years.

At the European level, medical devices are regulated in the framework of directives and regulations to be fully observed, and at the national level in the framework of the Medical Devices Act and various specific regulations. These legal framework conditions cover the conformity and certification procedures up to the subsequent distribution.

In the manufacture and distribution of medical devices, the sometimes complex issue of demarcation from other items, products and substances (e.g. pharmaceuticals, cosmetics but also food supplements or beverages) and the implementation of a conformity assessment procedure to obtain the CE certification required for placing on the market plays a decisive role.

Many years of experience in an international environment

Against this background, our international clients particularly value their many years of experience in this dynamic regulatory environment and seek our support in general issues of medical device law as well as in the areas of medical device advertising, the conduct of clinical trials for medical devices, liability for defective products, etc. under the Product Liability Act as well as the reimbursement of medical devices in the context of special health insurance schemes (§ 140a SGB V) and the procedure for evaluating new examinations. and treatment methods with medical devices of high risk class (§ 137h SGB V).

At the European level, medical devices and in vitro diagnostic devices are regulated by directives and regulations to be fully complied with, and at the national level by corresponding implementing laws and various specific regulations.

In this area, too, we see ourselves as a strategic partner for national and European clients, whom we are also happy to advise in the context of their international strategy.

We also support large global corporations in all matters relating to European and German framework conditions.

Our main areas of focus include:

  • Distinction to other product groups (pharmaceuticals/cosmetics/foodstuffs)
  • clinical testing of medical devices
  • EU certification system for medical devices
  • Framework conditions for research funding in medical institutions against the background of anti-corruption rules
  • Representation vis-à-vis supervisory authorities and BfArM
  • Distribution of medical devices
  • Reimbursement of medical devices in the GKV system
  • Advertising and competition law