News

Australian TGA issues guidance on regulating Software as a Medical Device (SaMD)

Australia’s TGA has released new guidance for Software as a Medical Device (SaMD), with strong focus on AI and adaptive algorithms. The document outli...

Maciej Dubowik Regulatory Affairs Associate

MDCG 2024-14 Rev.1 – Updated guidance on Master UDI-DI for contact lenses

The MDCG has updated guidance on the use of Master UDI-DI for contact lenses, one of the most widely used medical devices worldwide. The new rules str...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Scientist using a pipette in a laboratory, member of TEAM-NB medical devices association

Strengthening innovation pathways for orphan IVDs under the IVDR: Team-NB advocates regulatory flexibility

In Team-NB Position Paper on Orphan IVDs (July 2025) Team-NB is urging the Commission to create tailored pathways under the IVDR for orphan IVDs—offer...

Izabela Chodara Director of Strategy and Operations
Female doctor with folded arms standing in front of the Swiss flag, representing medical authority and regulation.

Switzerland revises clinical trial documentation requirements – new version of Swissmedic guideline effective June 2025

From June 2025, new rules apply to clinical trial submissions in Switzerland. Sponsors must follow a fixed document structure (eDok_KLV), plan for dua...

Emilia Geszczyńska Project Manager
Male doctor reviewing regulatory documents on a computer screen in a clinical office setting.

e-IFU for all medical devices intended for professional users – new Commission Implementing Regulation (EU) 2025/1234

The long-awaited Regulation (EU) 2025/1234 now allows manufacturers to provide e-IFUs for all devices intended for professional use. This marks a sign...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Magnifying glass focusing on the abbreviation IVD on a document, symbolizing in-vitro diagnostic scrutiny.

IVD performance studies clarified: MDCG 2025-5 answers 50 frequently asked questions

The MDCG 2025-5 FAQ offers essential guidance for sponsors of IVD performance studies. This article outlines key definitions, documentation routes, an...

Izabela Chodara Director of Strategy and Operations
Close-up of medical software interface displaying heart rate and human torso visualization on a screen.

Revised MDCG 2019-11 guidance: updated approach to qualification and classification of medical software

This update revisits how software should be qualified and classified under MDR, with specific emphasis on Rule 11. The article compares the 2019 and 2...

Maciej Dubowik Regulatory Affairs Associate
Doctor using futuristic touch interface to access digital health records and medical diagnostics.

Digital platforms and AI-driven medical software: new MDCG guidance on operator responsibilities and MDR/IVDR–AI Act compliance

New MDCG documents clarify the roles of platform operators under MDR/IVDR and the AI Act. As software becomes more complex, responsibilities shift to...

Katarzyna Wesołowska Board Member
A hand holding a glowing lightbulb with digital network lines symbolizing innovation and regulatory change in MedTech

MedTech Europe calls for 4 urgent systemic changes to MDR/IVDR

MedTech Europe urges the European Commission to adopt four targeted corrective measures to preserve access to thousands of medical devices in the EU...

Agnieszka Czapko Head of Regulatory and Start-up Department