Dr. Lücker - Rechtsanwalt - MP Recht

Medical devices

Every year, medical devices with a total value of about €210 billion are sold on the world market. Germany is currently the third-largest market, accounting for sales of €22 billion. 1,200 manufacturers, ranging from major companies to self-employed orthopaedic technicians, with a total of 210,000 employees, manufacture medical devices or place them on the market in Germany. The devices themselves range from bandages to pacemakers, from dental prosthetics to in vitro diagnostic materials and from surgical instruments to high-tech magnetic resonance scanners. The legal term “medical device” was only defined for the first time in 1994 in the course of the harmonization of EU legislation. Since then, manufacturers have been able to market their devices throughout the European Economic Area without any restrictions. However, manufacturers face considerably greater responsibility for the stringent testing, assessment and certification of their companies and their products.
We can provide expert advice on all matters and effective legal support for every step in the process.
The potential hazards posed by medical devices are correlated with the complexity of the laws and regulations to be followed. As a result, there is considerable demand for external advice. This applies both to manufacturers and other companies without specialized legal departments and to users and operators of medical devices, including hospitals, medical centres, etc. Everyone concerned faces considerable responsibility and must recognize this responsibility and take appropriate action to protect themselves. In addition, law firms who normally provide advice to companies are also confronted with medical device matters and themselves need the advice of specialist colleagues. The innovative law firm of MD-Law Luecker  has the specialist know-how that is needed: comprehensive, profound and always up-to-date.