Swissmedic Requirements: Device Notifications for Manufacturers
Swissmedic, which is affiliated with the Swiss Federal Department of Home Affairs, is responsible for the regulatory oversight of…
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Key Changes to Medical Device Registration with MHRA
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has implemented important updates to the registration process for medical devices.
EU MDR & IVDR: Certificates with Conditions to Support Innovation
The EU Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 provide a mechanism that…
FDA Increases Oversight on Data Integrity for Device Submissions
The U.S. Food and Drug Administration (FDA) is the U.S. government agency responsible for protecting public health by…
EHDS Regulation Published: Key Benefits for EU Healthcare
The European Health Data Space (EHDS) Regulation ((EU) Regulation 2025/327 amending Directive 2011/24/EU and Regulation (EU) 2024/2847) has…
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…
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…
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