News

Robot on blue background

Publication of the AI Act in the Official Journal of the EU

On 12 July 2024, regulation (EU) 2024/1689 was issued, introducing a regulatory framework for artificial intelligence (AI), the AI Act. The publicatio...

Agnieszka Czajkowska

SCHEER Updates Guidelines on Phthalates in Medical Devices

Phthalates, widely used as plasticizers in various industries, pose health risks due to their weak interaction with polymers, leading to potential hum...

Agnieszka Czajkowska

MHRA launches AI Airlock to address challenges for medical devices that use Artificial Intelligence

Last month, the MHRA outlined its strategy for regulating AI in response to a government white paper. This new pilot project aims to address challenge...

Katarzyna Wesołowska Vice President of the Board
European Commission building

European Commission’s Dashboard about reprocessing of medical devices

The concept of "reprocessing" in the context of medical devices refers to the process of safely preparing a used device for reuse through cleaning, di...

Agnieszka Czajkowska
Sterilization process

New standards for biocompatibility, sterilization and processing have been harmonised

Recently CEN and Cenelec revised the harmonised standards and added sterilization, biocompatibility, and processing standards to the list. The standar...

Agnieszka Czajkowska

New vigilance system guidelines for CE-marked medical devices MDCG 2024-1

In January 2024, a new MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template was created to standardize the way medical incidents, serious in...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

The US FDA published its final rule aligning U.S. quality regulations (QMSR) to international standards (ISO 13485)

The US FDA has released the awaited final decree on Quality Management System Regulation (QMSR), bringing its stipulations into alignment with the wid...

Katarzyna Wesołowska Vice President of the Board