Sep 24, 2019

The Regulatory Affairs Professionals Society (RAPS) Convergence conference recently held in Philadelphia covered various regulatory issues affecting medical device and technology sectors. Compliance challenges pertaining to clinical data management and Clinical Evaluation Reports (CER) constituted one such area of focus.

Emergo by UL organized a 1.5-hour session at the RAPS conference entitled “How to Review and Compile Clinical Data in a CER.” The session was attended by approximately 200 RAPS Convergence participants, and was moderated by Evangeline Loh (Ph.D., RAC), Regulatory Services Program Manager for Emergo by UL. Her co-presenters included Heather Crawford (MS, RAC, CBA), Senior Regulatory/Quality Consultant for Emergo by UL; Dona Occhipinti (MPH, CCRP), EU MDR Clinical Evaluation Lead for Hillrom Services; and Christopher Brodrick (M.Sc.), Design Dossier Evaluator for GMED North America.

Loh reminded the participants of the importance of utilizing the European guidance MEDDEV 2.7/1, Rev. 4 to facilitate planning for compliance with EU’s Medical Devices Regulation (MDR) (EU) No. 2017/745 as well as the state-of-the-art (SOA) assessment requirements under the MEDDEV 2.7/1 Rev. 4 guidance.

Occhipinti provided practical real-world perspectives from her experience with development of medical device manufacturers’ CERs. She also discussed potential approaches to addressing clinical evidence requirements for legacy devices, recently marketed devices and new product development under the MDR.  

Crawford presented a detailed overview of SOA as well as safety and performance literature searches. She described how to structure different literature searches (e.g., PICO), presented several techniques and tips for literature searching, and how to document the results.

Furthermore, participants were reminded of the importance of literature searching with both controlled vocabulary as well as natural language or keywords.

Brodrick shared different approaches for appraising clinical data and included many references to his previous Notified Body reviews. In particular, he mentioned combining the Level of Evidence potentially with quality of evidence and strength of recommendation. He also noted that one approach may be to use the already developed evidence rating system from professional medical associations, clinical specialties and journals.  

It was a stimulating session that made the audience realize that the highest quality of evidence may not always need to be from a systematic review or meta-analysis. And, it is pivotal to appropriately structure and develop one’s literature search and then critically assess the data. 

James Keller is Business Development Director at Emergo by UL.

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  • James Keller

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