Medical Device Blog

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...

Streamline MDR certification with AF Pharma! From pre-application to post-certification, we simplify compliance for seamless EU ma

AF Pharma ensures compliance with MDR Article 16, offering support in regulatory assessments, QMS, documentation, and notified body liaison.

Amazon GPSR compliance for selling in the EU

Ensure MHRA compliance with AF Pharma's UKRP services! From registration to UKCA marking, we simplify UK market access

Ensure MDR compliance with AF Pharma's PRRC services! From Article 15 duties to PMS and incident reporting, we streamline your EU products.

Expand your business on Amazon EU with AF Pharma's regulatory expertise.

Ensure MHRA PMS compliance with AF Pharma! From PMS plans to PSURs, we simplify surveillance, incident reporting, and corrective actions.

AF Pharma is now your trusted Australian Sponsor, ensuring TGA compliance, ARTG registration, and seamless market access for your products!

Appointing an EU Authorized Rep is vital for non-EU manufacturers. AF Pharma ensures compliance, documentation, and seamless EU market!