MDR and IVDR Compliance | A Notified Body Perspective
Daniëlle Sleegers, MedEnvoy’s Director of Regulatory Affairs & PRRC, will be moderating the sessions, guiding you through the complexities of…
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IMDRF Releases Consolidated Adverse Event Reporting Terms
The International Medical Device Regulators Forum (IMDRF) has released a consolidated document for Categorized Adverse Event Reporting (AER),…
New Zealand Medical Device Registration Guide
Unlike some medical device regulators, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) does not require pre-market approval…
GMDN Launches Arabic Version of Medical Device Nomenclature
We are excited to announce the official launch of the Arabic version of the Global Medical Device Nomenclature…
New Updates to HPRA Certificate of Free Sale Process
The National Competent Authority of Ireland, Health Products Regulatory Authority (HPRA), has updated the application certificate of free sale…
Swissmedic’s Focus Campaign: Key Outcomes on PMS Compliance
Swissmedic conducted a focus campaign to assess compliance with the post-market surveillance (PMS) requirements of the Medical Devices…
New IVD Registration Update Under MHRA
Under a new guidance document the EU provided new guidance for the EU IVDR transition extension under Article 110. This…
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…
Saudi Arabia Medical Device Registration Requirements
The Saudi Food and Drug Administration (SFDA) has aligned its medical device regulatory requirements with other major market frameworks,…
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