Dedicated webpages on MDR & IVDR (European Commission)

The European Commission has released dedicated webpages, which are divided in several areas, where you can find relevant Factsheets, Implementation timeline and other helpful documents:

  • Getting ready for the new regulations (EC main webpage)
    • Manufacturers MD (EC)
    • Manufacturers of devices without an intended medical purpose (EC)
    • Manufacturer IVD (EC)
    • Authorised Representatives, Importers, Distributors (EC)
    • Healthcare professionals and health institutions (EC)
    • Health institutions reprocessing single-use devices (EC)
    • Competent authorities in non-EU/EEA countries (EC)
    • The procurement of MDs and IVDs (EC)

The above documents are also available in our MDlaw Library of Documents – you can easily identify them by looking for ”manufacturer”, ”distributor”, ”hospitals”, ”competent authority”, etc. depending on your interest!

The European Commission also reminded of the approaching date of application of both Regulations:

On 26 May 2021, the Medical Device Regulation will become fully applicable, following the transition period. Please keep the revised deadline firmly in mind.

The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) remains in May 2022.

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