Articles from Dr. Christian Lindemann, LL.M.

17. May 2023 Due diligence of the distributor - OLG Celle specifies obligations of the medical device distributor pursuant to Art. 14 para. 1 MDR

Before a distributor is allowed to make a medical device available on the market, they must check whether the product complies with certain regulatory requirements. According to Art. 14 para. 1 of the Medical Device Regulation 2017/745 EU (MDR):"When making a device available on the market, distributors shall act with due care in relation to the applicable requirements."

Medical and social law
19. Mar 2020 Quality assurance agreements with distributors of medical devices

Regulation (EU) 2017/45 on medical devices (MDR for short) lays down regulatory obligations for distributors of medical devices for the first time. With this regulation, the European legislator is pursuing the goal of a smoothly functioning internal market for medical devices while at the same time ensuring quality and safety to protect the health of patients, users and third parties.

Medical and social law
19. Mar 2020 Quality assurance agreements between suppliers and manufacturers of medical devices

Regulation (EU) 2017/45 on medical devices (MDR for short) requires manufacturers to have a quality management system and a post-market surveillance system in place, which should be adapted to the risk class and type of device in question. Furthermore, a risk management system and a system for reporting incidents and safety corrective actions in the field must be set up. These high quality and safety requirements for medical devices are intended to dispel general safety concerns about these products in particular.

Medical and social law
28. Jul 2016 Incidents - an acid test for risk management User error as an incident

No medical device is free of risks. Dealing with fatalities and serious effects on the health of patients presents companies with ever greater challenges at a time of great political and social pressure on medical technology. This development places the highest demands on domestic and international communication with authorities, distributors and users and requires well thought-out crisis management that focuses on the manufacturer's risk management system. An overview of existing and upcoming obligations and liability risks was provided at the Medical Devices 2016 mini-symposium on June 29 in Reutlingen.

Medical and social law
28. Jul 2015 Current need for action to convert supply contracts

Current developments in medical device law require adjustments to the contracts normally used in supply chains. We would like to draw your attention to some of these points with this information. In addition, we would like to draw your attention to a number of erroneous or ineffective clauses in contracts for medical device supply chains, which we have recently encountered more frequently in our advisory practice:

Medical and social law