Tag: EU MDR

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2025

Medical Device

USA 1. Guidance on: Quality Management System Information for Certain Premarket Submission Reviews The guidance highlights the importance of submission of comprehensive, risk-based QMS documentation...

CDSCO India, EU MDR, FDA guidance, Global Regulatory News, MDA Malaysia, Medical Device Compliance, Medical Device Regulations, QMS, SaMD

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2025

Medical Device

USA Final Guidance: Computer Software Assurance FDA released its long-awaited final guidance on Computer Software Assurance (CSA), replacing Section 6 of the 2002 software validation guidance....

CSA software validation, eSTAR submissions, EU MDR, FDA guidance, Global Regulatory News, Health Canada, Medical Device Compliance, medical device cybersecurity, Medical Device Regulations, MHRA clinical investigations, TGA

Medical Devices – Europe, Asia and ROW Regulatory News – July 2025

Medical Device

BRAZIL Brazil Implements UDI Labeling for Class IV Medical Devices In July, Anvisa marks significant progress in the implementation of Unique Device Identification (UDI) in Brazil, requiring...

AI in Healthcare, EU MDR, HSA Singapore, IVD Devices, Medical Device Regulation, PMDA Japan, PSUR, Regulatory Compliance, SaMD, UDI Brazil

What Pharma Companies need to know about EU MDR Regulations?

Biopharma

EU MDR The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices The EU MDR entered into application on 26 May 2021 REGULATION...

Compliance, EU MDR, Medical Device Regulations, Pharmaceutical Industry, Regulatory Affairs

Medical Device Labelling Requirements

Medical Device

effective operation of a medical device must never rely on guesswork. Clear, accurate, and compliant labeling is essential, and every label associated with a device must meet the relevant regulatory...

Code of Federal Regulations, EU MDR, General Device Labeling, In Vitro Diagnostic, Medical Device Labelling, Medical Device Regulation, Unique Device Identification, US FDA

EU MDR Regulations

Standards

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of Act (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale...

EMA, EU MDR, EU MDR Regulations, EUDAMED, MDR