Blog

Regulatory Highlights 2025: The regulatory landscape shaping the European MedTech Sector in 2025

2025 reshaped the European MedTech regulatory landscape. New MDCG guidance, ISO 10993 and GCP R3 set the direction for software, IVDs and clinical res...

Katarzyna Wesołowska Board Member
Mężczyzna stojący przed stoiskiem Warsaw Medical Expo podczas konferencji medycznej 2025 – wydarzenie branży ochrony zdrowia, okulistyka i zarządzanie opieką zdrowotną.

Pure Clinical at Warsaw Medical Expo 2025 – insights, networking, and innovation

The November event marathon continued as Fryderyk Janiak, Business Development Manager at Pure Clinical, engaged in valuable discussions and gained ne...

Fryderyk Janiak Business Development Manager
Uczestnicy targów MEDICA 2025 pozują przy czerwonym logo wydarzenia – międzynarodowe targi sprzętu i technologii medycznych w Düsseldorfie.

Pure Clinical at MEDICA 2025 – four days of meetings, trends, and new opportunities

This year’s edition of MEDICA | Trade Fair for Medical Technology & Healthcare was exceptionally productive for Pure Clinical. Our delegation — Katarz...

Fryderyk Janiak Business Development Manager
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

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