Confused by the seemingly endless jargon that is so widely associated with the EU Medical Device Regulations? LRQA's #JargonBuster series uncovers the terminology that comes with getting to know this fascinating and ever-changing medical regulatory field.
#JargonBuster 1 - CE
The CE marking has been a symbol of free marketability in the European Economic Area since 1985. It stands for Conformité Européenne, meaning European Conformity, and is the manufacturer's declaration that the product meets the requirements of the applicable EU legislation.
#JargonBuster 2 - MDR
Medical Device Regulation (MDR)
The Medical Device Regulation (MDR) is a new regulation that will replace the existing Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC. It applies to all medical device manufacturers who intend to place their products in the EU.
#JargonBuster 3 - IVDR
ln Vitro Diagnostic Device Regulation (IVDR)
The ln Vitro Diagnostic Device Regulation (IVDR) is a new regulation that will replace the existing ln Vitro Diagnostic Devices Directive (IVDD) 98/79/EC. It applies to all IVD manufacturers who intend to place their products in the EU.
#JargonBuster 4 - MDSAP
Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the manufacturing of medical devices developed by the International Medical Device Regulators Forum (IMDRF). It is set to replace the existing Canadian Medical Devices Conformity Assessment System (CMDCAS) in January 2019.
#JargonBuster 5 - ISO 13485:2016
ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) is the newly revised international standard defining Quality Management Systems (QMS) requirements for organisations that manufacture medical devices or provide related services. The deadline for transitioning to ISO 13485:2016 is 1 March 2019.
#JargonBuster 6 - UDI
Unique Device Identification (UDI)
A Unique Device Identification (UDI) is a unique numeric or alphanumeric code identifying a medical device. It enhances traceability of devices, makes recalls of devices easier, combats counterfeiting, and improves patient safety.
Manufacturers must fit their devices with a UDI under the new medical device regulations set to be published in Q4 2016.
Watch this space as we unveil more #JargonBusters in the coming days!
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