News

Combined studies, two rulebooks: what CTR Q&A version 7.4 means for device sponsors

In October 2026, the European Commission published version 7.4 of the Questions & Answers on the Clinical Trials Regulation (EU) No 536/2014 (CTR). Th...

Małgorzata Pawlikowska Head of Clinical Study Department

Your next real-world dataset may come with a permit: the EHDS drafts its access templates

The European Commission has circulated a draft implementing regulation setting out common templates for the secondary use of electronic health data un...

Izabela Chodara President of the Board

No expiry date: Great Britain will keep accepting CE-marked devices and IVDs

On 21 October 2026, the UK Government confirmed that Great Britain will recognise CE-marked medical devices and in vitro diagnostic medical devices (I...

Fryderyk Janiak Business Development Manager

EN 18286:2026 harmonised: the AI Act finally has its QMS benchmark

For two years, manufacturers of AI-enabled medical devices have been told to prepare for the AI Act without a harmonised benchmark to measure themselv...

Katarzyna Wesołowska Vice President of the Board

New safety module in CTIS: from October, ASR reports will be submitted differently

For many sponsors, the annual safety report (ASR) is a routine process that is set to change from October. On 24 September, the EMA published a guide...

Justyna Grącka Clinical Project Manager

MDCG 2020-16 rev.5: new clarifications on the classification of IVD control materials

Control materials appear to be a straightforward classification case, but their class depends on one detail: whether the manufacturer has assigned a v...

Izabela Chodara President of the Board

COMBINE: how to report adverse events in trials combining a medicinal product with a medical device

A patient receives the investigational medicinal product. At the same time, they are implanted with a medical device or are eligible for treatment bas...

Adrianna Pyrzanowska Regulatory Affairs Associate

FDA announces mandatory eSTAR for PMA applications

Following 510(k) applications, it is now the turn of the most demanding US premarket pathway for medical devices. On 18 September 2026, the FDA publis...

Katarzyna Wesołowska Vice President of the Board

Team-NB calls for broader EUDAMED access for Notified Bodies. Here is what that could mean for your certificate

Team-NB, the European Association of Medical Devices Notified Bodies, has published a position paper responding to the proposed MDR/IVDR 2.0 reform. T...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department