News

Clinician using an AI diagnostic assistant on a tablet to analyse a lung CT scan, with neural network visualisation and ROC curve on a secondary monitor — illustrating high-risk AI medical software under the EU AI Act.

The European Commission is consulting on draft guidelines for the classification of high-risk AI systems. What does this mean for medical device manufacturers?

Draft EU guidelines confirm that every MDR/IVDR-regulated medical device with an AI component is automatically classified as high-risk under the AI Ac...

Izabela Chodara President of the Board
Healthcare professional in scrubs interacting with a holographic Gantt chart and digital clinical trial dashboard on a tablet, representing real-time clinical trial monitoring and data flow

FDA moves towards real-time clinical trials

FDA launches proof-of-concept real-time trials with AstraZeneca and Amgen plus a broader summer pilot — streaming key endpoints to regulators reshapes...

Ilona Korczak-Cegielska Director of Clinical and Regulatory Operations
Tablet displaying a holographic human anatomy and DNA helix surrounded by medical icons, stethoscope, syringe and patient history form, symbolising breakthrough medical device innovation

EMA Pilot for Breakthrough Devices

EMA launches a pilot in Q2 2026 to support breakthrough medical devices and IVDs — earlier dialogue with regulators, closer EMA/MDCG cooperation, high...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Businessman in suit adjusting a glowing pink-to-blue vertical slider between HIGH and LOW marked RISK, illustrating medical device risk classification under MDR

MDCG Updates on borderline and classification. Raising the bar for Medical Device Manufacturers.

Updated Borderline Manual (Version 5) and MDCG 2021-24 Rev.1 raise the bar for classification of medical devices — mode of action, software and substa...

Katarzyna Wesołowska Vice President of the Board
Long aisle between tall empty blue industrial warehouse shelves, representing medical device supply chain interruption and shortage risk under MDR Article 10a

MDR Article 10a – notification duties when supply is interrupted

From 10 January 2025 manufacturers must notify authorities at least six months before a supply interruption or discontinuation that could harm patient...

Adrianna Pyrzanowska Regulatory Affairs Associate
Professional examining regulatory compliance documents through a magnifying glass with digital document icons in the background

ISO 14155:2026 — A Revised Framework for Clinical Investigations under MDR: Practical Perspectives from Pure Clinical

ISO 14155:2026 brings a revised GCP framework for clinical investigations under MDR — covering PMCF, SaMD, and clarified stakeholder roles. A practica...

Katarzyna Wesołowska Vice President of the Board
A doctor in a white coat holding a stethoscope against the European Union flag background

Commission Delegated Regulation (EU) C(2026) 1798: expanded exemptions from clinical investigations under MDR

Commission Delegated Regulation (EU) C(2026) 1798 final amends Article 61(6)(b) of MDR, replacing the previous exemption list with an expanded catalog...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Laboratory scientist in blue nitrile gloves examining a specimen under a professional microscope

IMDRF CE-IVD Draft 2026: New framework for clinical evidence for in vitro diagnostics

IMDRF/CEIVD WG/N91 establishes a refined lifecycle-based framework for generating and evaluating clinical evidence for IVD medical devices, directly a...

Izabela Chodara President of the Board
A hand touching a digital world map with glowing network connections and data points

IMDRF N86: Standardising adverse event terminology in global medical device reporting

IMDRF N86 establishes harmonised adverse event terminology principles for medical device vigilance reporting, directly impacting how manufacturers str...

Adrianna Pyrzanowska Regulatory Affairs Associate