Medical Device Blog

The UK will align Class D IVD regulations with EU Common Specifications, replacing CTDA and easing market access. AF Pharma offers expert UKRP services to support manufacturers entering the GB market. Learn more at www.afpharmaservice.com.

Explore the latest FDA Q-Sub guidance (2025) updates and learn how AF Pharma can support your FDA submissions as your U.S. Agent for medical devices.

Learn how to create an MDR-compliant PMS Plan, what it must include, and how it supports post-market safety, clinical evaluation, and risk management.

Understand PSUR requirements under EU MDR: when it's needed, what to include, and how to maintain compliance through structured post-market reporting.

Stay MDR compliant: Learn what PMCF is, when it's required, and how to implement it to ensure clinical safety and performance post-market.

Understand the AI literacy obligations under Article 4 of the EU AI Act and what providers and deployers must do to comply, including training, risk analysis, and documentation.

Learn the key differences between ISO 13485 and ISO 9001 and why ISO 13485 is essential for medical device manufacturers aiming for regulatory compliance.

Request AF Pharma’s expert-led MedTech Regulatory Training to learn how to classify medical devices vs. cosmetics, understand mechanisms of action, and navigate global regulations across the EU, UK, US, and China.

MOCRA is transforming cosmetic regulations in the US. Learn what your brand must do to comply with FDA requirements—and how AF Pharma can support you with Responsible Person services, product listings, safety substantiation, and more.

Understanding clinical investigations in the UK is essential for medical device manufacturers. This article outlines MHRA requirements and highlights how AF Pharma, as your UK Responsible Person (UKRP), ensures regulatory compliance and market success.

Borderline Manual for medical devices

Germany’s digital health sector is booming, but navigating market access, regulatory compliance, and reimbursement pathways is challenging.

Nanotechnology is transforming medicine, but regulatory classification remains complex.

wissmedic’s 2025 focus campaign reviewed 30 legacy medical devices from non-Swiss manufacturers, revealing widespread non-compliance in PMS

The EU regulatory landscape for Digital Medical Devices (DMDs) is evolving, incorporating the MDR, IVDR, AI Act, and HTA Regulation.

The UK medical device regulatory framework is based on UK MDR 2002, with oversight by the MHRA.

Ensure IVDR compliance with AF Pharma's PRRC services! From Article 15 duties to PMS and vigilance, we provide expert support for your IVD.

Streamline FDA approvals with Q-Sub & 513(g)! Get early guidance on studies, pathways, and compliance. Partner with AF Pharma for experts

Stay ahead with IVDR 2025 updates! Streamline compliance, enhance safety, and simplify processes with AF Pharma's expert support.

Selling Lifestyle Products on Amazon EU Compliance and Market Readiness with AF Pharma Amazon’s European marketplace is a hub for...