In an effort to increase the safety and reliability of medical devices, regulators around the world are integrating additional clinical evidence requirements to support safety and efficacy; an initiative which is being led by Europe’s MEDDEV 2.7.1 revision 4 guidance, which outlines clinical evidence requirements for both new, unapproved technologies, as well as products that have been on the market for an extended period. The recently published MEDDEV 2.7.1 rev 4 has been approved and is currently active with no transition period, and moving forward, notified bodies will seek to review all device’s CERs, regardless of when the device was approved and placed on the market. Manufacturers must be transparent and detailed about the methods used and steps taken during the clinical evaluation process and provide detailed data analysis, process logs and lists of references. With no current determination on the level of acceptable data, manufactures should already be analyzing product portfolios, conducting impact assessments and collecting as much clinical data as possible to satisfy future requirements.
- Developing evaluation reports throughout the product life cycle
- Design and pre-market phase
- CE approval period
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
- Details on inclusion/exclusion criteria & usability requirements
- New & revised definitions: Sufficient clinical evidence & equivalence
- Device clinical database: What does this mean for manufacturers?
- Consistency clinical data, risk management file and state of the art
Anne Le Rouzo
West Coast Regional Director & Certification Project Manager / Lead Auditor
LNE / G-MED North America, Inc.