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…
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New Publication from Team-NB on Orphan IVD Devices
On 17 July 2025, Team-NB, the European Association of Medical Devices Notified Bodies – released a comprehensive position paper…
IVDR Transition Deadline What Happens After May 26, 2025
Prepare for the IVDR Transition Deadline on May 26, 2025. Learn what legacy IVD manufacturers must do to maintain EU market access.
Notified Body Audits: A Guide for Medical Device Manufacturers
Notified Body audits are a critical component of the conformity assessment process for manufacturers of non-self-certified devices under the…
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…
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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…
Personal Protective Equipment (PPE): Regulatory Requirements
Personal protective equipment (PPE) is a daily necessity in many occupations, including healthcare, and it is important to understand their…
EU Regulation 2024/1860: Key Changes for IVDR Compliance
New regulation amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR): Regulation (EU) 2024/1860: Gradual roll-out of EUDAMED, the obligation…
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