The UK Medicines and Healthcare products Regulatory Agency (MHRA) has wants public input on reforming its regulatory framework for medical devices and in vitro diagnostics (IVD). MHRA has opened ...

More Lenient Guidelines May Inadvertently Lead to a Scarcity of Consented Samples Recently, no area has contributed more and increasingly complex layers to the bioethics debate than research employing ...

On 3 April 2020, the European Commission issued a guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices ("IVD") in the COVID-19 context. The Guidance ...

The European Commission is offering guidance for device companies and other stakeholders trying to determine if their standalone software should be considered a medical device, in vitro diagnostic ...

In vitro diagnostics (IVDs) are a mainstay of modern medicine. People of all ages and their healthcare providers rely on these tests to determine the risk of a wide range of chronic and acute diseases ...

Research assistant Nicole Gebert contributed to this article. Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition ...

ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics ...

HiMedia is dedicated to maintaining high safety, quality, and performance standards for in-vitro diagnostic products used in healthcare. This commitment significantly enhances the well-being of ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

The Drugs Technical Advisory Board (DTAB) has agreed with a proposal to amend the Medical Devices Rules (MDR), 2017, to include definition of reportable events related to medical devices, in a move to ...