Medical Device Blog

A New Milestone in European Health Technology Assessment (HTA) On 17 October 2025, the European Commission adopted Implementing Regulation (EU) 2025/2086, establishing detailed procedural rules for conducting joint clinical assessments (JCAs)  of medical devices and in vitro diagnostic medical devices (IVDs) at Union level. This long-awaited implementing act builds on the framework of Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) and aligns it with the Medic

Market Entry doesn’t have to be slow or costly. Smart regulatory planning helps startups and manufacturers accelerate access to the EU, UK, US, and beyond transforming compliance from a burden into a strategic advantage. The Global Regulatory Maze - Market entry Expanding into international markets is a defining milestone for every manufacturer—but it can also be one of the most daunting. Divergent frameworks such as EU MDR/IVDR, UKCA, FDA, TGA, and Health Canada regulations

Clinical Decision Support Software in Australia: When Is It a Medical Device? Introduction As digital health technologies evolve, the boundaries between health apps and medical devices have become increasingly complex. To provide clarity, the Therapeutic Goods Administration (TGA) released updated guidance in October 2025 titled “Understanding Clinical Decision Support Software (CDSS)” , outlining how clinical decision support systems are regulated under the Therapeutic Goods

The EU MDR Rule 21 reshapes how substance-based and bioengineered medical devices are classified and approved. Learn how innovators in biomaterials, nanotech, and regenerative medicine can navigate compliance to bring disruptive therapies to market. The Changing Landscape of Medical Device Regulation The introduction of Rule 21 under the EU Medical Device Regulation (MDR 2017/745) has redefined how Europe regulates a new generation of medical devices, particularly those compo

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.

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.