The European Commission (EC) has published details of its proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. In addition, the EC proposes introducing a new procedure to address...more
In April 2017, the EU has revised the regulatory framework for medical devices and in vitro medical devices in the EU. The package, which includes regulation (EU) 2017/745 on medical devices (Medical Device Regulation or MDR)...more
A recent decision of the CJEU in Europe raises concerns for pharmaceutical companies who wish to supplement the protection of their products with SPCs. With its decision C 567/16 the court follows a strict approach and...more