Information for today’s Regulatory Professional

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We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.

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