Veristat’s Post

The European Commission published a revised version of Medical Device Coordination Group (MDCG) guidance 2021-5 on standardization for medical devices. Revisions include: 📌 Additions on the references to EN ISO 15189 and ISO 14155:2011 📌 Updates on the Harmonized Standards 📌 A new section handling common specifications Read more > https://hubs.li/Q02Fwbrs0 #MDR #IVDR #MedicalDevices

The Medical Device Coordination Group #MDCG has endorsed the new revision to MDCG 2021-5, Guidance on standardisation for medical devices. Among the changes to the #guidance are updates on 'state of the art': -  it is commonly considered that the most recent versions of standards with the technical solutions they contain reflect the “state of the art” - compliance with the most recent version of a standard the reference of which has not been published in the OJEU does not automatically imply compliance with the requirements of the applicable EU legislation When using #SOTA concepts with your device, you must remember that "state-of-the-art” standards as such do not confer any presumption of conformity if their references are not cited in the OJEU. https://lnkd.in/eZF4eFkc #standards #standardization #standardisation #medicaldevices #NSB #IVD

[BSI Compliance Navigator Blog] Access our library of medical device blogs today, receive updates on the latest medical device news and innovations. Access here: https://lnkd.in/eJmd5_p6 Follow Our Blog: https://lnkd.in/ekM636Wa #MedicalDevices #MDR #IVDR #MedicalDevicesBlog

[BSI Compliance Navigator Blog] Access our library of medical device blogs today, receive updates on the latest medical device news and innovations. Access here: https://lnkd.in/enQjc3tR Follow Our Blog: https://lnkd.in/egJqYArH #MedicalDevices #MDR #IVDR #MedicalDevicesBlog

[BSI Compliance Navigator Blog] Access our library of medical device blogs today, receive updates on the latest medical device news and innovations. Access here: https://lnkd.in/gaVP4ckw Follow Our Blog: https://lnkd.in/gdGqtx5z #MedicalDevices #MDR #IVDR #MedicalDevicesBlog

Medical device regulation provides a structured framework overseeing the manufacture and utilisation of medical devices. It has been designed to ensure medical devices are not only safe and high quality but are also perfectly suited for their intended use. Let’s take a closer look at why it is important: https://lnkd.in/dsz4wgbp

eIFU Requirements Under the EU MDR and Regulation 2021/2226 Explore what electronic Instructions for Use (eIFU) are, the EU regulations governing them, and the benefits they offer over traditional paper instructions for medical devices. Read more: https://lnkd.in/gTVS_tR8 #eIFU #MedicalDevices #EURegulations #HealthcareCompliance #MedTech #DigitalHealth #MedicalDeviceRegulation #ElectronicIFU #MedicalDeviceSafety #HealthTech #RegulatoryAffairs #MedicalDeviceIndustry #eLabeling #HealthcareInnovation #PatientSafety

Have your say on Electronic Instructions For Use (eIFUs) for medical devices in the EU Commission survey! Get all the details you need in our blog: https://hubs.li/Q02PZSFN0 #medicaldevices #productcompliance

Great reporting from Katie Hobbins on how #FDA is facing scrutiny over a huge increase in #meddevice recalls and in particular the Philips CPAP recall case. Katie writes that "congress is calling for a probe into how FDA tracks warnings about dangerous and recalled devices as well as how it takes actions against companies that put its customers at risk." What seems to be the reason for such an increase in recalls and adverse events⁉️ According to the article: "In 2022, nearly 900 medical devices were recalled by FDA, representing a 125% increase compared to 2012, which saw 399 recalls. "That number included 70 Class I recalls — FDA’s highest and most serious classification — becoming a 15-year high. "Medical device adverse event (AE) reports also increased by 505% from 2012 to 2022." https://lnkd.in/dZQwwZiZ ~~~ If you found this interesting, consider Reposting 🔄 and follow me Vincent F. Cafiso so you don't miss future content.

𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬: 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐂𝐨𝐮𝐧𝐜𝐢𝐥 𝐚𝐝𝐨𝐩𝐭𝐬 𝐧𝐞𝐰 𝐦𝐞𝐚𝐬𝐮𝐫𝐞𝐬 𝐭𝐨 𝐡𝐞𝐥𝐩 𝐩𝐫𝐞𝐯𝐞𝐧𝐭 𝐬𝐡𝐨𝐫𝐭𝐚𝐠𝐞𝐬 The Council has adopted new rules updating the law on #medicaldevices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: ⬆ further extending the transition period for certain #IVDs 🔄 enabling a gradual roll-out of #EUDAMED, the new electronic database ↕ requiring manufacturers to flag up potential shortages of critical medical devices and IVDs #mdr #ivdr #regulatoryintelligence #regulatorycompliance https://lnkd.in/d7EXSVym