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- Replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC)
- The regulation went into effect May 26, 2021 (Date of Application). This date was delayed due to COVID.
- Requirements for companies that currently hold an MDD.AIMD certificate are detailed in Article 120.
- Some of the new requirements of the MDR include:
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- Designation of a PRRC (person responsible for regulatory compliance)
- Increased responsibilities for importers, distributors, and Authorized Representative (collectively, they are “economic operators”)
- Much more robust requirements for post-market surveillance activities including the generation of specific records
- Device classification rules
- Essential Requirements in the MDD and 90/85 EC are replaced by the General Safety and Performance Requirements (GSPR)
- Implementation of the EUDAMED database to collect and share information regarding medical device manufacturers and their devices
ADVANCED QUALITY SYSTEM SOLUTIONS
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