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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September 3, 2022

[FREE WEBINAR] Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

Click here to watch the recording of this webinar.

How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device. 

Key Takeaways

  • How to address limited clinical and performance data
  • Learn how to adjust the Clinical Evaluation Plan to align with the regulatory strategy
  • Understand the concept of data sufficiency

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD & Scientific Writing Services 

Stacie Beecham, Principal Medical Writer 

Sign up for future webinars here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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August 17, 2022

The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success 

Author: Criterion Edge Writers

Regulatory Affairs (RA) professionals are poised to play a key role in supporting the clinical or performance evaluation report (CER or PER) process. Regulatory Affairs is active throughout the entire process, from pre-project planning through scoping and kick-off, report writing, review and sign-off, and finally, submission to the notified body.

How Can Regulatory Affairs Assist in the Clinical and Performance Evaluation Report Process?

The CER and PER are highly complex reports—not just because of the large amount of data they contain, but because they must tell a complex story. Putting all the evidence together for a successful submission is a difficult task, but RA is strategically positioned to provide critically important support and guidance to the evaluation writing team.

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August 8, 2022

[FREE WEBINAR] Bridging the Gaps: Determining When Clinical Data is Necessary to Demonstrate Conformity with GSPRs 

Click here to watch the recording of this webinar.

What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists, and the device meets specific criteria. In this webinar, we discuss the concept of data sufficiency. Specifically, we explain the differences between a well-established technology and a legacy device as defined by MDR and discuss strategies from both a regulatory and writer’s perspective. 

Key Takeaways

  • Learn what is deemed sufficient clinical data for certain device groups
  • Determine how to establish a legacy device as a ‘standard of care’ device
  • Understand the conformity assessment pathways for well-established technology devices

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD & Scientific Writing Services 

Stacie Beecham, Principal Medical Writer 

Sign up for future webinars here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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[Free Webinar] Ask the Expert: Clinical Evaluation Report Critical Concepts

Join us on Wednesday October 10th, 2022 at 11AM PST / 2PM EST, as President Laurie Mitchell answers your questions regarding safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. Learn best practices and writing strategies to support solid planning during your own writing process.

Spots are limited – click to register for this free webinar.

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