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PRRC

The new EU MDR 2017/745 and IVDR 2017/746 having new requirement called PRRC (person responsible for regulatory compliance).

PRRC FOR MANUFACTURER (ENTERPRISES EMPLOY >50 PERSONS AND WHOSE ANNUAL TURNOVER AND/OR ANNUAL BALANCE SHEET >EUR 10 MILLION):

  • Manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications.
    • A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
    • Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  •  Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

IMPORTANT NOTES:

  • It shall be noted that:
    (1), any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognized by an EU Member State as equivalent to the EU corresponding qualification.
    Professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU requirements in the field.
  •  Meaning of “within their organization”
    The person responsible for regulatory compliance (PRRC) appointed would need to be an employee of the organization.
  • Organizations with more than one legal manufacturer
    Organizations with more than one legal manufacturer under the parent company would need to ensure that each legal manufacturer has its own PRRC.
  •  Can the PRRC be located outside the EU?
    As to the location of the PRRC, it is important that a close linkage, of a permanent and continuous nature, is established between the PRRC and the manufacturing activities. For this reason, for manufacturers located outside the EU, it must be assumed that the PRRC should also be located outside the EU. On the other hand, for manufacturers located in the EU, it must be assumed that the PRRC should also be located in the EU.

PRRC FOR MICRO AND SMALL MANUFACTURERS (ENTERPRISES EMPLOY <50 PERSONS AND ANNUAL TURNOVER AND/OR ANNUAL BALANCE SHEET

  • “Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organization but shall have such person permanently and continuously at their disposal.”

IMPORTANT NOTES:

  • Meaning of “permanently and continuously at their disposal”
    The micro or small enterprise may subcontract the responsibilities of a person responsible for regulatory compliance to a third party, so long as the qualification criteria is met and the manufacturer can demonstrate and document how they can meet their legal obligations. For example, the PRRC may be part of an external organization, with which the manufacturer has established a contract laying down provisions so as to ensure the permanent and continuous availability of that party. The contract should mention the relevant person’s qualifications allowing compliance with points A and B (mentioned above).
  • Can the PRRC be located outside the EU?
    For micro or small enterprises located in the EU, it must be assumed that any person to be permanently and continuously at their disposal should be also located in the EU.

PRRC FOR AUTHORIZED REPRESENTATIVES:

  • Authorized representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications.
    • A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
    • Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

    IMPORTANT NOTES:

    • Meaning of “permanently and continuously at their disposal”
      The authorized representative may subcontract the responsibilities of a person responsible for regulatory compliance to a third party, so long as the qualification criteria is met and the authorized representative can demonstrate and document how they can meet their legal obligations. For example, the PRRC may be part of an external organization with which the authorized representative has established e a contract laying down provisions so as to ensure the permanent and continuous availability of that party. The contract should mention the relevant person’s qualifications allowing compliance with points A and B (mentioned above).
    • Can the PRRC be located outside the EU?
      Taking into account that the Authorized Representative is located in the EU, it must be assumed that any person to be permanently and continuously at its disposal should be also located in the EU.

    MINIMUM RESPONSIBILITIES OF THE PRRC:

    To ensuring that…..

  •  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.
  • The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
  • The post-market surveillance obligations are complied with in accordance with Article 10(10) [Article 10(9) of the IVDR.
  •  The reporting obligations referred to in Articles 87 to 91 [Article 82 and 86 of the IVDR] are fulfilled
    Manufacturers “shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88” (Article 10(13) of the MDR and Article 10(12) of the IVDR)
  •  In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV [Section 4.1 of Annex XIV of the IVDR] is issued.
    Manufacturers shall ensure that “a signed statement by the natural or legal person responsible for the manufacture of the investigational device [for performance study] that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation [performance study] and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.”

ROLES AND RESPONSIBILITIES OF THE PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE WITHIN AN AUTHORIZED REPRESENTATIVE:

  • The PRRC of an AR should be responsible for ensuring that the tasks of an AR as specified in the given mandate, in accordance with Article 11(3), are fulfilled.

For more information visit MAVEN PROFCON SERVICES LLP.

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