Laws & regulations

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Article • Regulatory challenges for AI-based diagnostics

Further IVDR changes: a step in the right direction, but…

New changes made to the timetable for the In vitro Diagnostic Medical Device Regulation (IVDR) across Europe could have a significant impact on manufacturers and users, an expert points out. While…

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Article • Impact of the new regulation

IVDR: Stop complaining, start contributing

The in vitro diagnostic regulation (IVDR) aims to make tests safer, more reliable, and sustainable. Unfortunately, it is also widely regarded a bureaucratic nightmare. At the ECCMID Day on…

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Article • Regulatory issues for AI and digital pathology

IVDR: a complex issue and a 'missed opportunity'

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.

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Article • New EU regulation

Lab tests: Watch out! Conflict ahead

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)…

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Article • Health IT

Interoperability: Insights from Down Under

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…

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Article • Cyberattacks and countermeasures

Healthcare cybersecurity in the EU and US: a technical, regulatory or political issue?

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…

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News • Photon counting

Major CT advancement receives FDA clearance

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…

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News • Medical Device Regulation

MDR certification for Agfa Class IIa solutions

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…

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Article • A painful divorce

Post-Brexit worries for UK healthcare

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.

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News • Regulatory issues

Genetic data privacy, the GDPR, and research needs: a delicate balance

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…

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Article • Medical device regulation revision

MDR: The UK goes it alone

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.

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News • Medical Device Regulation update

Lessons learned from implementing the MDR

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…

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Article • A major update

New medical device regulation comes into force

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…

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News • Challenges of an aging society

Dementia and gun ownership: an issue that needs regulation

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…

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News • Discerning good algorithms from bad ones

Medical AI evaluation is surprisingly patchy, study finds

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…

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News • Legal, ethical, medical challenges

12 things to consider before introducing Covid-19 vaccine passports

Covid-19 vaccine passports could be created, but significant challenges need to be overcome first, according to a report from a panel led by Oxford Professors Melinda Mills and Chris Dye, which outlines a dozen issues which must be addressed before passports can be introduced. The report is published by the SET-C (Science in Emergencies Tasking: Covid-19) group at the Royal Society and it…

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News • Underuse, overuse, or even misuse?

A critical look at the rising euthanasia rates in the Netherlands

There’s a 7-fold unexplained variation in rates of euthanasia across The Netherlands, reveals an analysis of health insurance claims data. It’s not clear if these differences relate to underuse, overuse, or even misuse, say the researchers. The Netherlands was the first country in the world to legalise euthanasia and physician-assisted suicide, introducing preliminary legislation in 1994,…

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Oversight of medical software

FDA Releases Artificial Intelligence/Machine Learning Action Plan

The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,”…

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News • EU collaboration proposal

Looking forward to a better European Health Partnership

Health industry sectors, representing pharmaceutical and medical technology companies (COCIR, EFPIA, EuropaBio, MedTech Europe and Vaccines Europe) welcome the publication of the European Partnership for Innovative Health Proposal as a significant milestone towards a European Partnership for Health Innovation. The future partnership will showcase to researchers, patients, and citizens that Europe…

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