Have you considered the impacts of the Medical Device Regulation (MDR) on your current risk documentation and management strategies? You may be wondering, what devices can be grouped together? Should you group your devices at all? How will these changes impact your Clinical Evaluation Report? In this episode of Chasing Compliance, Marysa Mezzetti, a Manager on the Medical Device team, and Jamie discuss how risk management and documentation practices must be considered for each device individually, implications of device lifetime, life cycle, and safety and performance objectives, and changes in the risk documentation language. While there is no clearly defined path forward for manufacturers, this episode provides some guiding principles that will help develop a sound MDR remediation strategy. Marysa ends their conversation with some tips and best practices regarding MDR-related changes to risk documentation. As always, Jamie wraps things up with Favorite  Friday.  

Key sections: 

• Basic overview of risk documentation, QMS, and MDD – 2:10 
• Who is responsible for writing risk documents – 6:45 
• Initial discussion of MDR – 8:05 

• New risk documentation considerations for device families - 12:20 
• MDR, Article 10, ISO 14971, and the Notified Body - 17:30 
• Changes in language in risk documentation and emphasis on overall risk compared to overall benefit - 22:30 
• Impact of risk documentation changes on clinical evaluation and Clinical Evaluation Report strategy – 27:20 
• How the CER writer can help the risk process - 29:00 

• Marysa’s tips and best practices for achieving and maintaining compliance - 31:15 

Abbreviations 

CER = Clinical Evaluation Report 

dFMEA = design failure modes and effects analysis 

FMEA = failure modes and effects analysis  

MDD = Medical Device Directive 

MDR = Medical Device Regulation  

PMS = Post Market Surveillance 

QMS = Quality Management System