News

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
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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
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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
Medical device manufacturing specialist reviewing quality documentation on a tablet in a controlled production environment.

Korean medical device GMP 2026 – updated KGMP requirements and MFDS inspection framework

Korean Medical Device GMP 2026 introduces stricter inspection expectations, deeper documentation requirements, and stronger integration between QMS an...

Katarzyna Wesołowska Vice President of the Board
Laboratory quality control process with sterile sample tubes and validated handling procedures in a regulated medical environment.

Building a Durable Evidence Base for IVDs through Sample Biobanking

IVDR requires that the performance of in vitro diagnostic (IVD) devices be assessed continuously throughout the product’s lifecycle. Access to biobank...

Wioletta Piotrowska Clinical Research Associate
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ALCOA in Medical Device Clinical Investigations: From Slogan to Rigorous Data Quality Requirements

In medical device clinical investigations, it is easy to focus solely on "major themes" such as the clinical investigation plan (CIP) or participant s...

Tatiana Dolińska Clinical Research Scientist
Medical laboratory samples with United Kingdom flag in the background representing UK regulatory framework for medical devices.

CE Recognition UK 2026 – UK medical device regulation changes and the future of CE marked devices in Great Britain

CE Recognition UK 2026 may become the most important regulatory shift in Great Britain since Brexit. MHRA is considering indefinite acceptance of CE m...

Adrianna Pyrzanowska Regulatory Affairs Associate
Healthcare professional using a digital device with a warning symbol, representing medical data compliance and risk management.

MDCG 2025–10: guidance on post-market surveillance (PMS) of medical devices (MDs) and in vitro diagnostic medical devices (IVDs)

MDCG 2025–10 brings practical clarity to post-market surveillance by outlining what an effective PMS system should look like for medical devices and d...

Agnieszka Mroczek-Krakowian Clinical Research Scientist
Laboratory technician transferring liquid sample into a test tube during clinical research.

ICH E6 (R3) Good Clinical Practice – what changed in 2025?

ICH E6 (R3) reshapes Good Clinical Practice by emphasizing end-to-end quality and proportionate risk management. The principles-based structure and an...

Lucyna Szczech Clinical Trial Manager