News

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 Board Member
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 Director of Strategy and Operations

CIPS Pilot Program – Coordinated Assessment of Clinical Investigations in the EU

The European Commission has launched the CIPS pilot program to streamline and accelerate the clinical investigation assessment process for medical dev...

Małgorzata Pawlikowska Head of Clinical Study Department

New Version of MDCG 2019-6 Rev.5 Document on Notified Body Requirements

The Medical Device Coordination Group (MDCG) has published a new version of the MDCG 2019-6 Rev.5 document, which includes updates on the organization...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

MHRA: IMDRF’s Latest Guidance on AI and Medical Device Software

On January, 2024, the IMDRF published guidance on Good Machine Learning Practice (GMLP) for Medical Devices and considerations for medical device soft...

Maciej Dubowik Regulatory Affairs Associate

New MDCG Guidelines: Publication of Clinical Investigation Reports Without EUDAMED

Publishing clinical investigation reports is a crucial aspect of compliance with MDR regulations. In the absence of a fully functional EUDAMED system...

Adrianna Pyrzanowska Regulatory Affairs Associate

MHRA: FDA’s Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

On November 26, 2024, the FDA published guidance on its transitional enforcement policy for changes in ethylene oxide (EtO) sterilization facilities f...

Adrianna Pyrzanowska Regulatory Affairs Associate