Laws & regulations

Photo

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…

Photo

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)…

Photo

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…

Photo

Council of Europe

Covid-19: what measures to combat fake vaccines?

Advice on the application of the Medicrime Convention in the context of counterfeit COVID-19 vaccines.

Photo

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…

Photo

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…

Photo

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,…

Photo

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,”…

Photo

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…

Photo

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.

Photo

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…

Photo

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…

Photo

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.

Photo

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…

Photo

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…

Photo

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…

Photo

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…

Photo

Questioning the Genetic Diagnostics Act

Self-help healthcare or face a penalty?

The fact that genetic research can reveal hereditary diseases has been transferred to medical practice for some time and, since 2010, the Gene Diagnostics Act (GenDG) has regulated permissible DNA tests in medical diagnostics and pedigree in Germany. The procedure has great potential, says Professor Jochen Taupitz - but also great risks are associated with it.

Photo

Surgical implant for damaged eyes

FDA approves first artificial iris

The U.S. Food and Drug Administration approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye. The iris is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual…

Photo

Profession

Swiss radiographers face many challenges

The radiographer in Switzerland faces many issues, from having the right education to positioning themselves both professionally and legally in the healthcare continuum. Before a large audience at ECR 2018, Yves Jaermann, head of the radiographers service Riviera-Chablais Hospital in Vaud Valay, reviewed the situation in his country. The profession of radiographer was born in 1896, when the first…

Photo

Defibrillator use

Italian law must change to improve survival from cardiac arrest

An Italian law requiring citizens to hold a certificate to use a defibrillator must change to improve survival from cardiac arrest, researchers argued today at Acute Cardiovascular Care 2018, a European Society of Cardiology congress. “Automated external defibrillator (AED) use before the arrival of the emergency medical services (EMS) plays a key role in improving victim survival from…

Photo

Medical packaging

Track and Trace technology and serialisation

With the European Union regulation on medical packaging coming into effect February 2019, Track & Trace technology and serialisation have become a key topic in the medical packaging industry. Work processes must now allow for the authentication of products with individual serial numbers printed on each or its packaging, a process called serialisation. The industry is adapting to the new…

324 show more articles
Subscribe to Newsletter