This year, the Medical Devices Regulation (EU) 2017/745 was adopted. It is abbreviated to MDR (Medical Device Regulation) and replaces medical device guideline 93/42/EEC.
The interpretation of the comprehensive legislative text poses major challenges for many of those affected. This is because The MDR entails legal risks, such as the aggravated liability risks and their depiction in the company organisation. The result is, among other things, adjustments in contracts.
Prof. Dirksen explains what the Medical Devices Ordinance means in practice for construction, research and operation at the 62nd GMDS Annual Meeting in Oldenburg on 18 September 2017. His lecture topic is „Medical Device Regulation: Importance for Manufacturing, Operation and Research – The View of the Lawyer“.
„To doctors, health scientists, health care specialists, who will be subject to the new Medical Devices Regulation (EU) 2017/745.“
Healthcare, Medical, Medical Devices Directive, Medical Devices Ordinance (EU) 2017/745, MDR, Medical Device Regulation, Medical Device Directive 93/42/EEC, Legal Risks, Liability Risk, Adaptation of Contracts, Research, Operation, Construction