New MDR and IVDR Factsheet from the European Commission

A new MDR and IVDR Factsheet for healthcare professionals and health institutions was published on 18th December by the European Commission.

Key Takeaways from the MDR and IVDR Transition Factsheet

The Factsheet gives a brief overview of the transition from Directives to MDR and IVDR with information important for healthcare institutions to know to ensure compliance and enhance patient safety. Important topics for healthcare professionals to know and look out for are covered.

Here are the key takeaways from the new MDR and IVDR Factsheet:

• • Risk Classification and Scope:
    • Medical devices are classified into four classes (I, IIa, IIb, III) based on risk, with the MDR reclassifying certain devices and expanding its scope.
    • In vitro diagnostic devices (IVDs) are categorized into four classes (A, B, C, D) with increased oversight by notified bodies.
  • CE Marking and Notified Bodies:
    • Devices must bear the CE mark to indicate conformity with the regulations. Higher-risk devices require certification by notified bodies.
    • High-risk devices undergo additional scrutiny by expert panels or reference laboratories.
  • Clinical Investigations and Performance Studies:
    • The regulations include reinforced rules for clinical investigations and performance studies, requiring detailed documentation and reporting.
  • In-House and Custom-Made Devices:
    • Health institutions can manufacture and use devices on a non-industrial scale under certain conditions. Custom-made devices are exempt from some regulatory requirements but must meet specific criteria.
  • Obligations of Economic Operators:
    • Manufacturers, authorized representatives, importers, and distributors have defined obligations
  • Post-Market Surveillance and Vigilance:
    • Manufacturers must implement post-market surveillance plans and report serious incidents. Member States must encourage reporting of safety issues by healthcare professionals and patients.
  • Unique Device Identification (UDI):
    • The UDI system enhances device traceability. Devices must be labelled with UDIs, and information must be entered into the European Database on Medical Devices (EUDAMED).
  • Labelling and Instructions for Use:
    • Labels must include detailed information and symbols indicating the presence of hazardous substances. Instructions for use must be clear and accessible.
  • Implant Cards:
    • Manufacturers of implantable devices must provide implant cards with detailed device information to patients.
  • Reprocessing of Single-Use Devices:
    • Reprocessing is allowed under specific conditions, with re-processors assuming the responsibilities of the original manufacturer.

The full Factsheet is available here.

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