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

Pure Clinical and MDR Regulator join forces under one brand

Autumn is a time of major change for us. After weeks — and indeed months — of preparation, Pure Clinical and MDR Regulator have officially merged and...

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

ISO 13485:2016 reconfirmed – regulatory and quality system stability secured until 2030

During the recent ISO/TC 210 Working Group 1 meeting held in Arlington, Virginia, it was officially confirmed that ISO 13485:2016 remains valid and un...

Katarzyna Wesołowska Board Member
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 RegulationSwissmedic, the Swiss Agency for Therapeutic Products, may now temporarily authorize high-risk medical...

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