News

Male doctor reviewing regulatory documents on a computer screen in a clinical office setting.

e-IFU for all medical devices intended for professional users – new Commission Implementing Regulation (EU) 2025/1234

The long-awaited Regulation (EU) 2025/1234 now allows manufacturers to provide e-IFUs for all devices intended for professional use. This marks a sign...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Magnifying glass focusing on the abbreviation IVD on a document, symbolizing in-vitro diagnostic scrutiny.

IVD performance studies clarified: MDCG 2025-5 answers 50 frequently asked questions

The MDCG 2025-5 FAQ offers essential guidance for sponsors of IVD performance studies. This article outlines key definitions, documentation routes, an...

Izabela Chodara President of the Board
Close-up of medical software interface displaying heart rate and human torso visualization on a screen.

Revised MDCG 2019-11 guidance: updated approach to qualification and classification of medical software

This update revisits how software should be qualified and classified under MDR, with specific emphasis on Rule 11. The article compares the 2019 and 2...

Maciej Dubowik Regulatory Affairs Associate
Doctor using futuristic touch interface to access digital health records and medical diagnostics.

Digital platforms and AI-driven medical software: new MDCG guidance on operator responsibilities and MDR/IVDR–AI Act compliance

New MDCG documents clarify the roles of platform operators under MDR/IVDR and the AI Act. As software becomes more complex, responsibilities shift to...

Katarzyna Wesołowska Vice President of the Board
A hand holding a glowing lightbulb with digital network lines symbolizing innovation and regulatory change in MedTech

MedTech Europe calls for 4 urgent systemic changes to MDR/IVDR

MedTech Europe urges the European Commission to adopt four targeted corrective measures to preserve access to thousands of medical devices in the EU...

Agnieszka Czapko Head of Regulatory and Start-up Department

FDA Q-Submission Program – Comprehensive guide for medical device manufacturers

The FDA’s May 2025 guidance updates and expands the Q-Submission process, offering manufacturers detailed pathways for obtaining feedback before marke...

Emilia Geszczyńska Project Manager
A large stack of medical documents with a stethoscope symbolizing FSCA and MIR reporting forms

MDCG publishes new MIR and FSCA reporting forms – streamlined system for serious incident and FSCA reporting

The European Commission has published updated templates for MIR and FSCA forms, standardizing how medical device incidents are reported. These documen...

Katarzyna Wesołowska Vice President of the Board
EMA report on real-world data from non-interventional studies for regulatory decision-making

EMA Reflects on Real-World Data in Non-Interventional Studies for Regulatory Use

Real-world data are increasingly used to support regulatory decisions throughout the product lifecycle. The EMA’s reflection paper offers scientific g...

Małgorzata Pawlikowska Head of Clinical Study Department

HealthData@EU – European Commission Launches Central Health Data Platform

The European Commission has released the source code of the HealthData@EU Central Platform as open-source software. This platform represents a corners...

Izabela Chodara President of the Board