Blog

Medical device. USG unit.

New EU guidelines for medical device supply continuity – MDR & IVDR

Article 10a obligations under MDR and IVDR Updated Manufacturer obligations under MDR and IVDR are presented in Regulation (EU) 2024/1860. It has been...

Katarzyna Wesołowska Board Member

What challenges will the medtech industry face in 2024?

Innovations and Development: Medical products typically have a lifecycle of only 18–24 months before a new and improved product emerges. This is just...

Adam Sobantka President of the Board

Changes in the guidance on MDR appropriate surveillance – MDCG 2022-4 Rev. 2

Are you the manufacturer who is using the transitional provisions? This guidance is for you. According to Article 120(3e) of the MDR, the notified bod...

Agnieszka Czajkowska Senior Regulatory and Clinical Affairs Consultant
Red pill with white Swiss cross symbol representing Swiss pharmaceutical or healthcare industry, placed among other medical capsules

Switzerland Introduces Simplified Market Access for High-Risk Medical Devices – A New Pathway for Innovation and Critical Situations

Key Provisions of the Federal Council Regulation Swissmedic, the Swiss Agency for Therapeutic Products, may now temporarily authorize high-risk medica...

Katarzyna Wesołowska Board Member

Health Business Innovation 2025 – Discussions on the Future of MedTech in Katowice

A Space for Dialogue on the Future of Healthcare Innovation The conference served as a platform for open discussions on the challenges faced by MedTec...

Fryderyk Janiak Business Development Manager
Scientist using microscope in laboratory. Close-up of a researcher's hands adjusting a modern microscope in a lab setting

Master UDI-DI for Optical Devices – MDCG Clarifies Timelines and Labelling Rules

Purpose of the Measure In accordance with Article 27 of the MDR and related delegated regulations, the introduction of the Master UDI-DI aims to simpl...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

Medbaltica 2025 in Riga – Innovations and Emerging Trends in MedTech

A New Perspective on Healthcare Trends Medbaltica 2025 attracted exhibitors from across Europe, showcasing modern diagnostic devices, rehabilitation t...

Fryderyk Janiak Business Development Manager

AI & MedTech CEE 2025: Conversations on the Future of Artificial Intelligence in Healthcare

On 26–27 September 2025, our team visited Riga to attend Medbaltica – the largest medical trade fair in the Baltic States. The event highlighted the l...

Fryderyk Janiak Business Development Manager
Scientist in a laboratory working on a computer with data displayed on the screen, viewed from behind.

FDA issues final guidance on Computer Software Assurance in production and quality systems

On 24 September 2025, the FDA published its final guidance on Computer Software Assurance (CSA) for software used in medical device manufacturing and...

Maciej Dubowik Regulatory Affairs Associate