The predictions of an apocalyptic melt down of the medical device industry has not (yet) come to fruition
Author archives: Kim Young, Director Global Regulatory Intelligence
Actor ID v SRN
The MDCG has issued additional guidance for registration of “other” actors in EUDAMED
Legacy Device Challenges
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.
MDR: New Beginning
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.
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 …
Class I MDR Compliance
The European Commission has published a very comprehensive factsheet intended to support the legal manufacturers of Class I medical devices
Importers – Strategic Partners
Medical device manufacturers must provide regulatory teams with the tools and resources to ensure compliant interactions with their supply chain partners.
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 …
Continue reading “Authorised Representatives: Effective Collaboration Required”
26 May 2021 and the Burden of Mandatory Collaboration
Revenue Streams: Only as Strong as the Weakest Link
China – NMPA:396
What does your China regulatory strategy look like?