The Manufacturer's Guide to the Revised Medical Devices Directive
Revisions to the Medical Device Directive 93/42/EEC (MDD) and the Directive for Active Implantable Devices 90/385/EEC were published in 2007. The amendments, along with changes to Directive 98/8/EC (concerning the placing of biocidal products on the market) are combined in to the 2007/47/EC Directive.
Included in the Medical Device Directive are requirements for:
- Labeling of devices containing phthalates
- Reprocessing and labeling of sterile, single-use devices
- Notified Body review of technical documentation
- Validation of software – regardless of the device class
- Archiving for implantable devices
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