Obtaining CE mark Flashcards
What’s CE mark?
Indicates that the device is in conformity with the requirements in the EU regulations that apply to the device.
GSPR
General Safety and Performance Requirements
How GSPR (MDR) is compared to Essential Requirements from MDD?
Expand on the Essential Requirements of the MDD with new provisions related to software, devices incorporating either medical substances or materials of biological origin, and risks associated with use by lay persons.
STED
Summary Technical Documentation
What are the key points of the GSPR?
- State of the art concept—not new but much more prominent in MDR/IVDR
- Greater emphasis on risk management and benefit-risk analysis
- New requirements related to biological substances, IT, and lay users
- New labeling requirements, including UDI
What’s state of the art?
The definition that best reflects the Philips interpretation of “state of the art” in MDR is the accepted standard of care, which can change over time.
What’s the “Conformity assessment path” path chosen by our company?
Assessment of a quality management system and technical documentation for the device. (Annex IX of the MDR is roughly equivalent to Annex II of the MDD.)
MDR QMS Req. - Regulatory requirements
- Additional technical documentation
- Interaction with European Database for Medical Devices (EUDAMED)
MDR QMS Req. - Product design
- General Safety and Performance Requirements (GSPR)
- Clinical evaluation
- Clinical investigation
MDR QMS Req. - Product design
- General Safety and Performance Requirements (GSPR)
- Clinical evaluation
- Clinical investigation
MDR QMS Req. - Labeling
- Content of labels and Instructions for Use (IFUs)
- Implant cards
- Interaction with EUDAMED
- UDI
MDR QMS Req. - Post Market Surveillance
- Periodic safety update reports (PSUR)
- Post Market Clinical Follow-up (PMCF)
- Post Market Surveillance plan
- Vigilance detail
What are and why do we need Notified Bodies (NBs)?
- Notified Bodies are organizations designated by a Member State to assess conformity for medical devices and IVDs. The EU Commission publishes a list of Notified Bodies.
- Notified Bodies are the gatekeepers for CE marking for most devices. Only non-sterile, non-measuring Class I devices are exempt.
- Without the CE mark, we cannot place our products on the EU market
What are the controls that NBs are in charge as per EU MDR (~2020)?
EU Oversight Liability Clinical Evaluation/Trials Scrutiny Procedure Traceability Post-Market Surveillance Economic Operators' Obligations EUDAMED Electronic Submission Hazardous Substances
Who monitor’s the NBs?
The EU MDR requires Competent Authorities (CAs) to monitor Notified Bodies.
