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    Appointment Letter PRRC

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    Musyoka Urbanus
    The management of COMPANY NAME appoints PRRC name as its Person Responsible for Regulatory Compliance according to article 15 of the EU Medical Device Regulation. As PRRC, they are responsible for ensuring device conformity, maintaining technical documentation, complying with post-market obligations, fulfilling reporting requirements, and issuing statements for investigational devices. The company gives the PRRC authority and resources to perform these tasks and ensure their permanent availability.

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    Appointment Letter PRRC

    Uploaded by

    Musyoka Urbanus
    175 views1 page
    The management of COMPANY NAME appoints PRRC name as its Person Responsible for Regulatory Compliance according to article 15 of the EU Medical Device Regulation. As PRRC, they are responsible for ensuring device conformity, maintaining technical documentation, complying with post-market obligations, fulfilling reporting requirements, and issuing statements for investigational devices. The company gives the PRRC authority and resources to perform these tasks and ensure their permanent availability.

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    appointment-letter-prrc

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    The management of COMPANY NAME appoints PRRC name as its Person Responsible for Regulatory Compliance according to article 15 of the EU Medical Device Regulation. As PRRC, they are responsible for ensuring device conformity, maintaining technical documentation, complying with post-market obligations, fulfilling reporting requirements, and issuing statements for investigational devices. The company gives the PRRC authority and resources to perform these tasks and ensure their permanent availability.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    175 views1 page

    Appointment Letter PRRC

    Uploaded by

    Musyoka Urbanus
    The management of COMPANY NAME appoints PRRC name as its Person Responsible for Regulatory Compliance according to article 15 of the EU Medical Device Regulation. As PRRC, they are responsible for ensuring device conformity, maintaining technical documentation, complying with post-market obligations, fulfilling reporting requirements, and issuing statements for investigational devices. The company gives the PRRC authority and resources to perform these tasks and ensure their permanent availability.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 1

    Appointment as Person Responsible for Regulatory Compliance

    Effective from DATE, the management (top management) of COMPANY NAME appoints
    PRRC name (company name, if external)
    as its Person Responsible for Regulatory Compliance (PRRC) according to article 15 of the
    EU Medical Device Regulation (EU) 2017/745 (MDR). COMPANY NAME acts as a
    manufacturer of medical devices within the scope of the aforementioned EU Regulation.
    The PRRC has to ensure that:
    1. the conformity of the devices is appropriately checked, in accordance with the
    quality management system under which the devices are manufactured before a
    device is released;
    2. the technical documentation and the EU declaration of conformity are drawn up and
    kept up-to-date;
    3. the post-market surveillance obligations are complied with in accordance with
    Article 10(10) of the regulation;
    4. the reporting obligations referred to in Articles 87 to 91 (MDR) are fulfilled;
    5. in the case of investigational devices, the statement referred to in Section 4.1 of
    Chapter II of Annex XV (MDR) is issued.
    The company gives the PRRC the necessary authority and responsibility to perform the
    tasks and provides the appropriate resources.
    The PRRC ensures permanent and continuous availability in accordance with the
    contractual agreement.

    Place, Date
    Management Representative // Person Responsible for Regulatory Compliance

    Template Copyright openregulatory.com. See template license.


    Please don’t remove this notice even if you’ve modified contents of this template.

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