The divergence in political perspectives that led to Brexit and Swixit has given rise to distinct regulatory representatives for Medical Devices: EC REP for the EU/EEA, UKRP for the United Kingdom, and CH-REP for Switzerland. Consequently, manufacturers are now required to engage with three representatives instead of just one.
Amidst this tripartite representation, an intriguing possibility emerges — the potential to streamline compliance endeavours by identifying commonalities within the regulatory frameworks across these regions.
Learning Objectives:
Understand strategies for utilising shared Regulatory elements.
Implement an innovative approach to enhance and synchronise regulatory representation for enterprises operating within these territories.
Ensure participants not only understand the guiding principle that a single "verification" process can pave the way for three distinct registrations but also gain practical skills in implementing this approach effectively.
