Standards

India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.

While anticipation grows around the European Commission’s forthcoming medtech proposal, due in mid-December, a series of EU documents have been published on topics including recertification, standards, changes to companion diagnostics and the latest notified body announcements.

Clinical evaluation and standards expert Danielle Giroud celebrates progress on the document and looks at what it means internationally and for the EU.

Recent key updates include new guidance on trend reporting, classification decisions, and opportunities for industry.

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Two years after the EU adopted the original common specifications for certain products under the IVD Regulation, the commission has added new products and updated its requirements.

A new reference in the document reminds the medtech sector that EU harmonized standards remain voluntary to encourage innovation.

Andrew Trister, Verily’s chief medical and scientific officer, discusses Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Plus, the Google health tech spinout's plans for the Study Watch, the Alzheimer’s research landscape, and AI development and regulation in a new era of uncertainty.

Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.