Freelancing consultants face several challenges, among others disguised employment. In general, disguised employment might arise, if a self-employed contractor should be classified as an employee with the rights and duties legally regulated. The consequences of working effectively as an employee, are not harmless, quite the opposite. Consultant, client and intermediary must pay taxes on wages, social insurance […]
NASAL SPRAYS, ORAL SPRAYS & LOZENGES – ARE YOU FAMILIAR WITH THE REGULATORY AMENDMENTS DUE TO THE MDR?
As you might already know, medical devices need to be approved according to the MDR after May 25, 2020. This regulatory amendment will bring significant changes in the approval of medical products, which will lead to additional efforts and the need of further experts. In general, medical products need to be classified again according to the […]
A quality management system is inevitable in order to successfully pass the regulatory approval process and thus to market medical devices in the EU. Currently are two major regulatory changes which might delay the CE-approval of medical devices: TRANSITION TO THE ISO 13485:2016 In general, if you want to market medical devices of risk class 1s, 1m, […]
The MDR will lead to additional efforts for the successful regulatory approval of medical devices. The following stricter requirements need to be implemented by the end of the transition period in May, 2020 in order to market your medical devices futher on: medical devices may shift to higher risk classes, e. g. nasal sprays establishment […]
THE UNITED KINGDOM LEAVES THE EU The withdrawal process has already started and is expected to be effective in March 2019. One major advantage of a common market was the recognition of regulatory approvals and thus the free movement of goods. As this recognition won’t be granted, the BREXIT will have a tremendous impact on […]