EU Launches Evidence on Targeted Revision of MDR and IVDR
The European Commission has launched a Call for Evidence on the planned targeted revision of the Medical Device Regulation (MDR,…
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MDCG Issues Master UDI-DI EU Guidance for Contact Lenses
Today, the EU published an updated revision of the Medical Device Coordination Group (MDCG) Guidance document…
Notified Body Proposed Reform: EU Medical Device Governance
The EU medical device regulatory landscape is at a critical juncture, as concerns grow over fragmented implementation and the urgent…
ISO 13485 Medical Devices: Global Regulatory Compliance
ISO 13485:2016 standards play a fundamental role in global regulatory compliance for medical devices. Nearly 30 years after the initial…
The MDR Transition: Key Insights for MDR Certification Renewal
During RAPS Convergence 2024, one of the main topics on the agenda was the status of the transition from MDD…
Understanding the Role of Notified Bodies in MDR Compliance
Similar to the role of Economic Operators, it is important to recognize that Regulation (EU) 2017/745 (MDR) includes a…
The Essential Guide to EU MDR Medical Device Classification
Early device classification is essential, especially if you have a complex…
EU MDR
EU IVDR
US Agent
General
UK Responsible Person
Egypt Registration Holder
Australian TGA Sponsor
QA Consulting
Swiss Authorized Representative
Global Medical Device Classification Frameworks and Regulations
Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
Upcoming Deadline for MDR Conformity Assessment Agreements
As the September 26, 2024, deadline for MDR Conformity Assessment Agreements rapidly approaches, medical device manufacturers are reminded of the…
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