News

April 11, 2024

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, disinfection, sterilization, and related procedures. The European Commission's Directorate-General for Health and Food Safety commissioned a study to evaluate the implementation of Article 17 of the MDR on the EU market. As part of the study, a dashboard has been developed to provide an overview of mapping activities related to the reprocessing and reuse of single-use devices in the EU.

March 26, 2024

Software and legislation and medical devices

“Software in the context of medical device legislation” – this was the slogan of this year’s conference, organized by TÜV NORD Polska. – A very interesting event in terms of content – emphasize our representatives. – A lot of content concerns, among others: software topic in relation to medical device regulations. Generally, a large dose […]

March 21, 2024

Three days at SALMED 2024

– Thanks to the combination of the event with the LABEXPO fair, approximately 300 companies from Poland and abroad and over three thousand visitors visited Poznań during three days – emphasizes Katarzyna Wesołowska, CEO of MDR Regulator. – As an exhibitor, under the Pure Clinical banner, we were there for the first time and I […]

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 […]