FAQs

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  • Is a formal act of appointment necessary?

    The appointment is made by letter of appointment from the company. This letter must be signed by a person sufficiently authorised to represent the company, preferably by the company’s managing directors. The letter of appointment must be countersigned by the PRRC. A template “Letter of Appointment” is available.

  • We are manufacturers. Does the PRRC have to be an employee of our company?

    Yes. A manufacturer must have available at least one PRRC within its organisation. This means that an internal PRRC needs to be appointed. This also applies to manufacturers of custom-made devices. Exceptions are made for micro and small enterprises. They may appoint an external service provider to act as their PRRC. The authorized representative may also appoint an external PRRC.

  • Can the internal PRRC use the services of external service providers?

    Yes, this is permitted. The fact that the PRRC himself or herself must belong to the manufacturer’s organisation does not mean that he or she cannot use the services of external service providers in the performance of his or her duties. The PRRC must additionally have the necessary powers to give instructions to employees of the enterprise for the purposes of implementing the required measures in the performance of his or her duties.

  • Does the PRRC have to be registered?

    Yes. The PRRC must be registered in the electronic EUDAMED database. Even though the EU Commission has now given notice that the setting up of EUDAMED with all its new functions will probably not be completed before May 2022, the appointment of the PRRC must be carried out in due time, by 26 May 2020.

  • What documents can be used as evidence of professional experience in regulatory affairs or in quality management?

    The following supporting documents can be used for this purpose:

    Employment contract evidencing that the person works in the area of regulatory affairs or in quality management and also since when he or she has done so.

    Organisation chart evidencing the function

    Evidence of training completed on topics such as quality management, medical device law, market surveillance, risk management, reporting

    Records such as audit reports and approval of documents

    If the company concerned is a German company and the person has already acted as a safety officer under Section 30 German Medical Devices Act (MPG), thus performing some of the tasks of a PRRC, the registration of this person with the German Institute of Medical Documentation and Information (DIMDI) as a safety officer can also be used as evidence of the relevant professional experience.

    If other Member States have hitherto had in place statutory provisions in accordance with national medical device law which required a responsible person who performed some of the tasks of a PRRC, proof of this function can also be used as evidence of the relevant professional experience.

  • Does the PRRC have documentation obligations?

    Yes, the PRRC has comprehensive documentation obligations. Where possible, templates will be made available to keep the administrative effort to a minimum and support the PRRCs in the performance of their duties.

  • May more than one person be appointed as PRRC?

    Yes, according to the Medical Device Regulation, a number of persons may be jointly responsible for regulatory compliance. In this case, their respective areas of responsibility must be stipulated in writing.

    However, this option will not be made use of during the introductory phase. If necessary, we will decide at a later date whether more than one person should be appointed in light of the comprehensive duties and responsibilities.

  • How independent is the PRRC in the performance of his or her duties?

    There is a prohibition on disadvantages for the PRRC. The PRRC shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties. It is unclear to date how the Member States will transpose this prohibition into national law. It is also unclear how the national labour courts will deal with this prohibition (possibly right to obtain a cease and desist order under employment law or separate protection against dismissal).

  • We have one additional site who is a distributor only, and where no manufacturing takes place. Which would be the appropriate letter template for this one?

    A distributor is only obliged to appoint a PRRC if he assumes the obligations incumbent on manufacturers. This is the case if the distributor does any of the following:

    a) makes available on the market a device under its name, registered trade name or registered trade mark. However, the distributor may also enter into an agreement with the manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in the Medical Device Regulation (MDR). In this case the distributor is not required to appoint a PRRC.

    (b) changes the intended purpose of a device already placed on the market or put into service;

    (c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.

    However, the above-mentioned provision does not apply if the distributor assembles or adapts for an individual patient a device already on the market without changing its intended purpose. Nor shall the provision of information (labelling and package leaflet), including its translation, or any other information necessary for marketing in the Member State concerned be regarded as a change affecting conformity. It should therefore first be carefully examined whether the conditions under a) – c) are fulfilled and the appointment of a PRRC is required.
    If a PRRC has to be appointed the letterhead “Manufacturer” will be the appropriate template.

  • Which nomination letter should be used when using an external PRRC for a micro or small business?

    Micro and small manufacturers are not required to appoint a PRRC within their organization but shall have such a person permanently and continuously at their disposal. Therefore, the appointment of an external PRRC is an option. ?An agreement must be concluded with the external service provider. This agreement should stipulate that the person assuming the task of the PRRC has the qualifications required by the Medical Device Regulation (MDR). It must also me agreed that the manufacturer will have this person permanently and continuously at their disposal. ?

    In addition, the person that assumes the role of PRRC should sign the letterhead to confirm that he/she accepts the office and duties and he/she has the qualifications required. Annexes 1 and 2 must also be completed. Deviating from the template the letterhead should indicate that the PRRC is an external PRRC: “ We herewith appoint [title, first and last name], [function], employee of [external service provider] as External Person responsible for regulatory compliance (PRRC) according to Article 15 REGULATION (EU) 2017/745 …”.?This provides a document that can be presented to the authorities if required.

  • Is it possible to have one centralised PRRC for several locations?

    Yes, under certain conditions. According to article 15(1) every manufacturer (including manufacturers of custom-made devices) shall have available at least one PRRC within their organisation. Only micro and small businesses (>50 employees, >10 Mio. € Revenue) are allowed to not have such a person within their organisation, as long as they have one permanently at their disposal.