Black Friday

Why is your regulatory data stored in regional silos? Why is there a requirement for inter-departmental data requests? Why does it take 3 days, 3 weeks, 3 months to find what you are looking for? Why must the regulatory team triple check spreadsheets for data accuracy? Why are weekly registration update meetings scheduled throughout your …

EUDAMED Alternative Solutions

Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional MDCG 2021-1 Rev.1 The objective of the guidance is to describe the harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional, anticipated for 26 May 2022. The proposed solutions aim to allow all …

Authorised Representatives: Effective Collaboration Required

Are you a global medical device organisation without a physical location in Europe? Of course, you are aware of the medical device regulation MDR 2017/745 mandatory requirement to appoint an EU Authorised Representative [(AR) or (EC REP)] to represent your company to the European competent authorities. Remember, this legal obligation is applicable for the marketing …