Preparing for EU MDR Post Market Reporting EU MDR continues to pose challenges as companies prepare to recertify devices and bring new technologies to the European market. One of the big changes in the regulatory framework of EU MDR versus the current medical device directive (MDD) is the focus on post market surveillance (PMS) …
EU MDR: Ensuring Labeling Compliance In July 2023, the European Parliament granted an extension to the new European Union Medical Device Regulation (EU MDR). This extension acknowledges the challenges that have arisen due to slow market readiness and lack of notified bodies, and grants companies additional flexibility to meet the demand for safe, innovative …
Bringing Digital Health Products to the Global Market In recent years, the growth and acceptance of digital health products has skyrocketed. Global regulation and market access for these devices, however, is as variable as the potential indications they address. We spoke with Megan Coder, Vice President for Product and Policy at the Digital Medicine …
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EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose Adopted in 2017, the EU Medical Device Regulation (MDR) brought a host of changes. In its Annex XVI, for example, the regulation expands its scope to take in new product groups referred to as “products without an intended medical purpose”—in …
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UK Releases Draft Post Market Surveillance Requirements for Medical Devices The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023,” are approved, they will pertain to devices sold in England, Wales, Scotland and …
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MRI Safety Testing: Making Implants More Compatible with Magnetic Resonance Imaging Magnetic resonance imaging (MRI) is key when it comes to diagnosing and treating complex injuries or diseases. For spinal injuries or degeneration or different types of cancer there is rarely any better way to diagnose. Problems that may lead to serious conditions can …
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Bringing your Medical Device to the UK: What You Need to Know about UKRP When it comes to medical device regulations, it is a time of transition for a number of countries. Both the EU and the UK are in the process of making significant changes to their regulations: Europe is in fact transitioning …
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The MDR Deadline Extension: Use the Time Wisely On March 15, 2023, the European Parliament amended the original Medical Device Regulation (MDR) to lengthen the compliance period for certain medical devices and in vitro diagnostic devices. The move provides device manufacturers with additional time to prepare their products for market and offers a buffer …
Facilitating Connections with MedTech KOLs Input and support from experts within your target disease area are vital to the development and commercialization of new medical technologies. But it can be difficult, especially for new companies, to make connections with physician experts, or key opinion leaders (KOL), in health care. In May, Veeva, a provider …
What’s Happening in the UK and Switzerland The implementation and extensions of EU MDR/IVDR have caused significant stress on regulatory departments. These challenges have been compounded by Brexit and the UK’s announcement that it would not adopt EU MDR/IVDR and the Swiss National Council’s vote to allow FDA-approved devices into the Swiss market. During …
