The Current State of Medical Device Regulations: Strategies to Support a Successful Technical Documentation Assessment (TDA)

Here we are, nearly eight years after the publication of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745 (MDR). As the May 2025 deadlines loom, many manufacturers are facing the reality of what implementing these regulations actually entails. While the manufacturers seem to have been given more time, a lack of clarity about clinical evidence expectations has left many companies struggling.  

In spite of these extended deadlines, manufacturers continue to face challenges in implementing these regulations. Key pain points include: 

• Escalating costs of obtaining and maintaining certifications, leading to budget uncertainty
• Challenges finding qualified regulatory affairs professionals and technical writers
• Lack of clarity regarding clinical evidence requirements
• Unclear expectations from IVD and medical device Notified Bodies 

In this webinar, we will discuss strategies to support your Regulatory Affairs team as they strive to meet the requirements for technical documentation, drawing from our experience with clinical evidence expectations for the Performance/Clinical Evaluation Reports (PERs/CERs) and Post Market Surveillance Reports for a wide range of medical devices and IVDs. 

Learning objectives: 

• Discuss common challenges (and deficiencies) identified during the Notified Body review of the PER/CER and PMS reports.
• Explain how Technical Documentation Assessments (TDA) can affect your timeline for certification.
• Provide real-world examples to illustrate the cost-effectiveness of preparing and planning for these extensive requirements early in your product’s lifecycle.
• Describe our approach to meeting clinical evidence expectations through well-defined research questions, targeted systematic literature reviews, and well-organized templates.
   

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