Explore regulatory requirements, market entry strategies and product registration opportunities across Latin America. Expanding into South America off...
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Insights from a Software-Focused Notified Body
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...
Switzerland Moves Toward Market Access for U.S. Medical Devices
On 29 June 2026, Switzerland issued a declaration under the Joint Statement on a Framework for a United States-Switzerland-Liechtenstein Agre...
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...
EU Publishes Delegated Acts on Well-Established Technologies (WET)
The European Commission has published two delegated acts on Well-Established Technologies (WET) under the Medical Devices Regulation (EU) 20...
EU AI Act Update — More Time, Same Expectations
The European Parliament has approved a major adjustment to the AI Act timeline, voting overwhelmingly to adopt a Digital Omnibus package design...
You want to start EUDAMED registrations – but can’t⁉️
Several times per week we solve this particular problem. The diagnosis 🔍: The first user registering a company often does not have suffi...
Transition to the new “EU REP” Symbol!
The European regulatory landscape for medical devices continues to evolve. A key recent development is the formal transition from the long-esta...
EUDAMED advice for free! We bust EUDAMED myths 💡
Numerous misunderstandings exist around EUDAMED. We are happy to share and clarify them for you! Exemptions and further aspects may apply...
