Still Maintaining Duplicate MDD/IVDD- and MDR/IVDR-Compliant Documentation?

Your regulatory team is über-organized and has been maintaining duplicate sets of technical documentation for your legacy devices, in compliance with the old MDD 93/42/EEC and IVDD 98/79/EC and the new MDR 2017/745 and IVDR 2017/746. You’re doing this because even though your device has a valid CE Marking certificate that expires between 2023 and 2025, the MDR and IVDR are now the law of the land and you need to manage two sets of documents to maintain compliance with […]

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MDCG 2022-6: Making Changes to Legacy Devices Without Triggering EU IVDR Compliance

It’s no surprise that big changes are ahead for in vitro diagnostics (IVD) manufacturers selling in Europe. While many of these companies are benefitting from a delay in enforcing the full new in vitro diagnostic regulation (IVDR), about 10% of IVD manufacturers have devices in their portfolio holding valid CE Marking certificates issued under the old In Vitro Diagnostic Directive (IVDD). Those manufacturers must comply with the IVDR no later than May 26, 2025 or when their certificate expires, whichever […]

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Which EU Notified Bodies Are “Designated” Under the MDR 2017/745 and IVDR 2017/746?

EU MDR & IVDR Updates

UPDATED August 5, 2022 Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. There is no current list of Notified Bodies seeking designation but some have indicated their intent on their website and we have added them in the pending list below. As Notified Bodies are officially designated, we will add them here. Help us keep this information up to date. Email us with corrections or additions. YES! EU Notified […]

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The New IVDR Compliance Deadline Extension Explained

The European Commission – after catching heat from Notified Bodies and industry players alike – finally came to the conclusion that perhaps forcing a May 2022 compliance deadline on thousands of ill-prepared in vitro diagnostic (IVD) manufacturers was not going to end well. As such, the recent decision by the commission to create a rolling action related to the IVDR date of application for many classes of devices was an 11th-hour mea culpa that was painfully obvious to IVD manufacturers […]

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