Laws & regulations

Photo

Article • How to bring about better patient outcomes with health data

Propelling innovation in healthcare with the help of health data spaces

January 28 saw the celebration of the “Data Protection Day” as it is called in Europe, or respectively the “Privacy Day” as it is referred to outside of Europe. It marks the date on which the…

Photo

News • Sustainability assessment

EU laws need to look at the environmental impact of pharmaceuticals, study finds

Current EU regulation does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study from Finland concludes.

Photo

News • Potential and pitfalls of CRISPR

Gene therapies raise difficult legal and ethical questions

New advanced therapies can alleviate or cure chronic diseases. But medical progress, such as the gene editing tool CRISPR, raises the question of how rights should be protected and balanced.

Photo

News • Medical Device Regulation

Esaote reports MDR readiness

Medical imaging and healthcare IT company Esaote reports that it has completed the transition of its medical devices to comply with the new Medical Device Regulation (MDR).

Photo

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…

Photo

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…

Photo

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) 2017/746). Even modified tests and laboratory-developed tests will present a problem for hospitals and labs as explained by Dr Thomas Streichert.

Photo

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 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.

Photo

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…

Photo

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…

Photo

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.

Photo

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…

Photo

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.

Photo

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…

Photo

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…

Photo

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…

Photo

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…

344 show more articles
Subscribe to Newsletter