Laws & regulations

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Eye health

FDA Approves biosimilar to treat macular degeneration disease

The FDA approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions.

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Covid_19

France gets tough on unvaccinated health workers

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.

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Experts on new IVD regulation

"We predict the loss of a large number of critical diagnostics"

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran a survey in July 2021 to gather data from IVD…

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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…

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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…

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CRISPR and co.

Patent law could curb unethical human-genome editing

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…

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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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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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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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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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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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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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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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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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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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Rebuttal

EDQM responses to concern on its Blood Guide

On May, 29th 2020, European Hospital published a press release from the Plasma Protein Therapeutics Association (PPTA). In that release, the PPTA expressed their concerns about the recommendations contained in the 20th version of Blood Guide of The European Directorate for the Quality of Medicines and Healthcare (EDQM). Read here the EDQM’s rebuttal letter to the PPTA.

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Medical device regulation

First hearing implant manufacturer to receive MDR certification

Austria-based cochlear and hearing implants technology company Med-El has become one of the first manufacturers worldwide, and the first and only hearing implant manufacturer in the world, to be granted European Medical Device Regulation (MDR) certification. The company made an initial announcement on the newly earned certification after making an early commitment to adopt the MDR in 2016. For…

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Experts express concerns

EDQM Blood Guide could make Europe more dependent on US plasma

The Plasma Protein Therapeutics Association (PPTA) is concerned about the recommendations contained in 20th version of Blood Guide of The European Directorate for the Quality of Medicines (EDQM) which aims to harmonise standards and recommendations on blood collection, preparation, and the use of blood and blood components. This Guide, if applied, will have a negative impact on the availability…

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Medical Device Regulation

How the new MDR may hurt patients in the short term

The intentions behind the Medical Device Regulation (MDR) are good. Ultimately, the regulations should prevent inferior medical devices, technologies and pharmaceuticals from endangering peoples’ lives while increasing the quality of drugs and devices entering the market. At the same time, MDR could present several serious immediate challenges to European healthcare systems.

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Dutch experts discuss

On the implications of the coronavirus

The coronavirus last week reached the Netherlands and began to spread around the country. How has the Dutch population reacted? What is a useful frame of reference for this situation? And what are the legal guidelines for dealing with the outbreak? Four researchers from the University of Amsterdam – a clinical microbiologist, an anthropologist, a social scientist and a health lawyer – explain…

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Diagnostics & therapy

AI: Hype, hope and reality

Artificial intelligence (AI) opens up a host of new diagnostic methods and treatments. Almost daily we read about physicians, researchers or companies that are developing an AI system to identify malignant lesions or dangerous cardiac patterns, or that can personalise healthcare. ‘Currently, we are too focused on the topic,’ observes Professor Christian Johner, of the Johner Institute for…

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Personalized medicine

FDA approves first targeted therapy for metastatic bladder cancer

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa…

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Breast healthcare

FDA advances landmark policy changes to modernize mammography services

The U.S. Food and Drug Administration (FDA) announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve…

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