Should increased scrutiny be applied to the oversight of laboratory developed tests?
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 …
The predictions of an apocalyptic melt down of the medical device industry has not (yet) come to fruition
The MDCG has issued additional guidance for registration of “other” actors in EUDAMED
To date, no horsemen of the apocalypse or world annihilating meteor strike has befallen the medical device industry. However, the continued management of MDD legacy device data is an altogether different cataclysm.
The act of maintaining MDR compliance now represents one of the biggest challenges for Medical Device companies entering or continuing business in the European market.
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 …
The European Commission has published a very comprehensive factsheet intended to support the legal manufacturers of Class I medical devices
Medical device manufacturers must provide regulatory teams with the tools and resources to ensure compliant interactions with their supply chain partners.
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 …