• EU MDR certification for Prolira!

    Regulatory Milestone: Prolira has EU MDR certification!

    We are proud to announce that Prolira is one of the first medical device companies in the world, to be certified according to the new EU MDR.

    Prolira’s EU MDR certifiction is the result of a big team effort headed by Uschi and Rutger. We also wish to thank QAid for its full support and DARE!! Medical Certifications for the effective and constructive auditing and certification process.

    The European Medical Device Regulation (EU MDR) guarantees safety and quality requirements for medical devices being manufactured or imported into Europe. It underwent fundamental revisions in 2017 to improve transparency through standard data, technological advances and the creation of an EU (EUDAMED)database. While the MDD was simply a set of guidelines, MDR is legally enforceable by EU member states.

    DeltaScan® is an EU registered trademark (Certificate Nr 018280613) Version 2.0

    Postal Address (for every letter/parcel/package):
    Prolira BV, Kruytgebouw, UInc
    Winthontlaan 30C
    3526 KV Utrecht
    The Netherlands

    Visiting Address:
    Prolira BV, Kruytgebouw
    Padualaan 8
    3584 CH Utrecht


    +31 (0)85 060 1656