In this expert webinar, MDSS explores the regulatory perspective on software and software-focused medical devices with insights from a Notified Body. ...
EUDAMED: The 60-Day Challenge
With the mandatory EUDAMED registration deadline approaching, manufacturers need to ensure that their device data and registration activities are read...
The role of the Importer under the MDR/IVDR — Myths, Misconceptions, and Real Obligations
This session addresses common myths regarding the Importer role under the MDR/IVDR, clarifying the regulatory requirements applicable to Importers and...
Online Seminar: Substantial Changes – Annex IX 2.4
Despite the regulation’s clear wording, uncertainty remains widespread across the industry, with differing interpretations and expectations between ...
Annex IX 2.4 – A logical approach
When does a change become “substantial” under the MDR/IVDR—and when must your Notified Body be informed? MDSS is seeing a rising number of quest...
Saturday Night Thoughts: A Few Minutes on MDR/IVDR
Structured Dialogue, supports early and transparent exchanges between manufacturers and notified bodies to set expectations and reduce incomple...
What is the Australian IDID?
Australia’s new UDID system is here…but what does it mean for your medical devices? This video gives you the essentials you need to know an...
Substantial changes to the QMS: Annex IX 2.4
Welcome to the MDSS Campus!...
Sponsor and Legal Representative vs Authorized Representative
This educational video explains the roles and responsibilities of the Sponsor and Legal Representative under Article 62. It also highlights how...
What is the MDR?
The MDR (Medical Device Regulation) refers to Regulation (EU) 2017/745, the European Union’s legal framework governing the placing on the mar...
