September 13, 2022

MDCG 2022-12: “Alternative Solutions” Document. Interim Guidance for IVD Manufacturers  

Author: Criterion Edge Writers

What You Need to Know  

The Medical Device Coordination Group (MDCG) released a new document (MDCG 2022-12) to establish guidelines for in vitro diagnostic medical device (IVD) manufacturers while the EU awaits the European Database on Medical Devices (EUDAMED), a project that was scheduled to be completed years earlier than its now-projected date of Q2 2024.  

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September 6, 2022

European Commission Announces EUDAMED Will be Ready in Q2 2024 – But Can We Believe It? 

Author: Criterion Edge Writers

What You Need to Know 

Already delayed by 4 years, the European Database on Medical Devices (EUDAMED), a European Union (EU) database considered to be the foundation of the EU medical device and in vitro diagnostic regulations (MDR and IVDR), now has an updated timeline for launch, according to the European Commission

Mark Your Calendar  

When the database becomes operational, the following timeline is expected. Of note, it remains uncertain whether EUDAMED modules will have a staggered release.  

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May 16, 2022

[FEATURED] EU’s Risk Management Standard Officially Recognized In Context of the IVDRU

Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is that it is arguably one of the most needed standards by the IVD industry after the medtech quality management standard, ISO 13485.

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May 9, 2022

[FEATURED] EU IVD Regulation: Guidance on Significant Changes Now Available

With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published which discusses “significant changes” for legacy IVDs.

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March 16, 2022

“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits

Author: Stacie Beecham

Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, the European notified body association, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines.

The primary concern cited is that Europe faces a likely device shortage for patients due to the more complex and longer certification processes required under MDR/IVDR. The demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs), with only 25 NBs for MDR, and 6 for IVDR, as compared with 51 NBs designated for MDD, and 21 under the AIMDD/IVDD Directives.

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