By the end of this year, medical devices EU regulations changes are expected, which are neccessary for:
- adaptation to technological, scientific and regulatory developments,
- overcoming of weaknesses of the existing system (improvement of medical devices safety and their free circulation within the internal market)
- regulatory framework supportive for innovation and the competitiveness of the medical device industry.
Two regulations will substitute three directives and are expected to bring more harmonisation and more clear rules.
Directly after regulations acceptance, raPHARM will organise a detailed education in this topic. Kindly let us know your interest in advance.