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Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing
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UDI-DI Timelines Contact Lenses and Spectacles
MDCG 2025-7 outlines deadlines for implementing Master UDI-DIs for contact lenses, spectacle frames, and reading spectacles. Ensure MDR compliance with AF Pharma as your EU Authorized Representative.
Maria


UK IVD Alignment
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.
Maria


FDA QSub 2025
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.
Soledad


PMS Plan
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.
Maria


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


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


Article 4 of the EU AI Act
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.
Soledad


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


Medical Devices Cosmetics Training
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.
Soledad


MOCRA FDA
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.
Maria


Clinical Investigations UK
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.
Maria


Borderline Manual
Borderline Manual for medical devices
Maria


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


Nanotechnology Based Medical Products
Nanotechnology is transforming medicine, but regulatory classification remains complex.
Soledad


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


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


Medical Devices in the UK: New Guide for Manufacturers
The UK medical device regulatory framework is based on UK MDR 2002, with oversight by the MHRA.
Maria


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


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


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