Despite a five-year transition period for In-vitro Diagnostic Medical Device Regulation (IVDR), experts fear many actors in the field are still not prepared for the regulations coming into force.
In May 2022 a shortage of several lab tests may come as many manufacturers struggle to comply with EU regulation requirements covering in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746). Even modified tests and laboratory-developed tests will present a problem for hospitals and labs as explained by Dr Thomas Streichert.
With interoperability stalled, stakeholders are seeking new ways to create an interoperable ecosystem. IT specialist Jason Steen describes the state of interoperability in Australia and calls for more governmental commitment and international standards.
The pandemic has put a spotlight on the increasing role of cyberattacks and weaknesses in healthcare. In healthcare as in other industries, cybercrime does not stop at national borders. With this idea in mind, the US consulate general in Düsseldorf and the US embassy in Vienna recently invited interested parties to their Cybersecurity in Healthcare Briefing.
Since 2015, the number of known ransomware attacks has not only increased substantially across many industries. Hospitals, and the healthcare industry in general, have also become favorite targets of ransomware attackers, leading to very real incidents in which patient care and patients’ lives have been put at risk.
The U.S. Food and Drug Administration (FDA) cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or therapeutic procedures; and monitoring the effectiveness of certain therapies,” said…
The FDA approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions.
Thousands of unvaccinated French health workers face suspension without pay under a new COVID-19 law that punishes people in care professions who refuse to get immunised against the virus.
MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran an industry survey, which shows an urgent, high risk to the availability of IVD medical tests once the new IVD Regulation fully applies.
Agfa HealthCare is proud to be one of the first companies to receive the new European Medical Device Regulation (MDR) certification, which was issued by Intertek on 25 August 2021. This certification, which covers Agfa HealthCare’s Class IIa Enterprise Imaging and Xero Viewer solutions, ensures that Agfa HealthCare can continue to deliver to customers innovative solutions that meet their real…
Brexit could have a potential impact on healthcare delivery across the UK, according to an expert in the field. Dr Hugh Harvey believes that will be particularly noticeable in the area of Medical Device Regulation (MDR), with the UK and Europe seemingly going in different directions on the subject after the UK left the European Union (EU) at the end of last year.
A new paper co-written by a University of Illinois Urbana-Champaign scholar who studies the legal and ethical implications of advanced biotechnologies outlines an unexplored tool to regulate the medically and ethically dubious practice of heritable human-genome editing: patent law.
The EU’s General Data Protection Regulation (GDPR) has created a great deal of uncertainty about how key requirements should be interpreted. This means that collaborators in international genetic research projects do not always agree on fundamental issues such as whether they are processing personal data, consent requirements under the GDPR and on what basis genetic data can be transferred…
With new Medical Device Regulations (MDR) now in force across Europe, the UK has chosen to retain pre-existing rules while also introducing mechanisms to allow it to draw up separate rulings for the sector in the future. The MDR took effect on May 26, aiming to harmonise and strengthen the pre-existing regulatory regime for medical devices, and enhance protection for consumers.
26 May 2021 marks the Date of Application of the European Medical Device Regulation (MDR). Replacing the Medical Devices and Active Implantable Medical Devices Directives, the Regulation is a welcome update for patient safety, transparency, and access to medical devices for Europeans. COCIR has been contributing to the development and implementation of the MDR since the very first discussions in…
New regulations covering medical devices are set to come into effect across Europe. Originally intended to be implemented in May 2020, the introduction of the updated Medical Device Regulation (MDR) was delayed because of the coronavirus pandemic. The new regulations – the first major update in three decades – now come into force on May 26, and to mark the date a special conference discussed…
In Sweden, there are over 2 million legally owned firearms. At the same time, up to 150,000 people live with a diagnosis of dementia. In an aging society such as Sweden, legislators will face challenges in gun ownership. A new registry-based observational study by researchers from NVS, Karolinska Institutet, published in the Journal of Alzheimer’s Disease shows a need for strategies for this…
Advice on the application of the Medicrime Convention in the context of counterfeit COVID-19 vaccines.
In just the last two years, artificial intelligence has become embedded in scores of medical devices that offer advice to ER doctors, cardiologists, oncologists, and countless other health care providers. But how much do either regulators or doctors really know about the accuracy of these tools? A new study led by researchers at Stanford, some of whom are themselves developing devices, suggests…
