News ⚕️ Pure Clinical

New MDCG Guidelines: Publication of Clinical Investigation Reports Without EUDAMED

Publishing clinical investigation reports is a crucial aspect of compliance with MDR regulations. In the absence of a fully functional EUDAMED system...

Adrianna Pyrzanowska Regulatory Affairs Associate

MHRA: FDA’s Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

On November 26, 2024, the FDA published guidance on its transitional enforcement policy for changes in ethylene oxide (EtO) sterilization facilities f...

Adrianna Pyrzanowska Regulatory Affairs Associate

Sterilizing medical instruments in autoclave

The US FDA updated the list of AI/ML-Enabled Medical Devices, authorizing 950 devices

The US Food and Drug Administration (FDA) plays a crucial role in regulating and overseeing the safety, effectiveness, and quality of medical devices...

Maciej Dubowik Regulatory Affairs Associate

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’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

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