News

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

The Packaging and Packaging Waste Regulation (PPWR) is now in force, what it means for medical device manufacturers?

As of 12 August 2026, the Packaging and Packaging Waste Regulation (PPWR), Regulation (EU) 2025/40, applies across all 27 Member States, replacing the...

Adrianna Pyrzanowska Regulatory Affairs Associate

IMDRF sets out essential principles for Predetermined Change Control Plans in medical device software

The International Medical Device Regulators Forum (IMDRF) has finalised guidance on Predetermined Change Control Plans (PCCPs), a mechanism that lets...

Katarzyna Wesołowska Vice President of the Board

ISO/TS 24971-2:2026 – New Guidance for Machine Learning-Enabled Medical Devices

In June 2026, ISO published ISO/TS 24971-2:2026, a technical specification clarifying how the risk management principles of ISO 14971 should be applie...

Maciej Dubowik Regulatory Affairs Associate

MHRA streamlines the Parallel Review procedure. How to submit when a study is both a CTIMP and a medical device clinical investigation?

In July 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published updated guidance on the so-called Parallel Review - the proc...

Izabela Chodara President of the Board