Articles from Franziska Dunker, LL.M.

6. Apr 2020 Simplified procedure for Corona SARS-Cov-2 virus pandemic respiratory masks (CPA)

Due to the increasing demand for respiratory masks, the European Commission issued a recommendation on March 13, 2020, allowing market surveillance authorities to

Medical and social law
2. Apr 2020 Help for hospitals through COVID-19 Hospital Relief Act? Compensation payments to hospitals due to special burdens caused by COVID-19

The COVID-19 Hospital Relief Act is intended to support all companies and individuals working in the healthcare sector in coping with the coronavirus crisis. The aim is to compensate for loss of revenue, reduce bureaucracy and impose sanctions. Whether the COVID-19 Relief Act will do justice to this will only become clear in the coming weeks. Initial doubts are being raised.

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
18. Mar 2020 Coronavirus newsletter and the impact on intensive care services

The coronavirus is keeping everyone on their toes at the moment, especially in the healthcare sector. In addition to the problem of increasingly scarce protective clothing, intensive care services, among others, have recently been increasingly confronted with various employment law issues due to the coronavirus. This involves a large number of cases, the most important of which we have selected below.

Medical and social law
11. Mar 2020 Increased requirements for custom-made products in accordance with the MDR

The entry into force of the MDR in May 2020 will also place stricter requirements on custom-made products. In addition, the MPDG, which replaces the Medical Devices Act in May 2020, provides for more precise regulations on the required written prescription.

Medical and social law

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