News

March 7, 2024

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 standards and the amendments satisfy the requirements which they aim to cover, and which are set out in Regulation (EU) 2017/745. Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements […]

February 22, 2024

Second call for EU reference laboratories for high-risk IVDs

EU Reference Laboratories according to the IVDR should be enabled to verify by laboratory testing the performance presented by the manufacturer and the compliance of devices of highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance. Following […]

February 7, 2024

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 incidents and reporting trends are reported.  It is the responsibility of medical device and in vitro diagnostic medical device manufacturers to monitor adverse events, evaluate them and report them to the relevant competent […]

February 1, 2024

Our delegation on MedTech Summit 2024 in Budapest

During the prestigious event in Hungary, our representatives gave lectures (“Clinical trials of innovative medical devices – challenges and regulatory consequences” by Katarzyna Wesołowska) and participated in very interesting debates (discussion panel with the participation of representatives of notified bodies and our Adam Sobantka entitled “MDR/IVDR trasition strategies and opportunities”), and in the meantime they […]

February 1, 2024

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 widely acknowledged ISO standard. The stakeholders in the industry have until February 2, 2026 to comply with these rules. It is very important note for the manufacturers willing to start with their devices […]

January 19, 2024

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 one indicator that the medtech sector is rapidly evolving, so much so that regulations struggle to keep up with progress. Most importantly is that with our help, upcoming changes will become more […]

December 22, 2023

A year in our industry and our company

We’ve had a very interesting and intense year in our industry, so it’s time for a little summary! Here’s what’s worth remembering from the vast calendar of 2023: III.2023 – Changes of transitional periods (MDR/IVDR) and removal of the “sell off” periods V.2023 – Advertisement rules for medical devices (PL) VI.2023 – Distributors database (PL) […]

December 7, 2023

AI and the future of medicine at the MedStar Innovators conference

“When possibility meets reality” – this quote accompanying one of the presentations perfectly captures the essence of today’s MedStar Innovators conference “AI and the future of medicine”, organized in cooperation with Google. Today, they met in one place, among others: healthcare industry leaders and representatives of startups with innovative technologies. – Representatives of offices from […]

December 5, 2023

Medical Research Agency conference

Our representatives – Katarzyna Wesołowska and Adam Sobantka – took part in the Medical Research Agency conference. This renowned state institution will celebrate its 5th anniversary next year and plans to be intensively involved in the development of Clinical Research Support Centers in the near future. ABM’s new project will also include moderating discussions, research […]