26 May 2020 is the date of the definitive application of the European Regulation 2017/745 (MDR 2017/745) on Medical Devices. The new MDR 2017/745 will bring many changes that will affect all the involved economic operators.
One of these novelties concerns the introduction of a new figure in the enterprises organizational chart: the “Person Responsible for Regulatory Compliance” (PRRC).
The responsibilities and obligations of the PRRC are well defined in Article 15 of the MDR 2017/745 (please click here for further details on the PRRC features and requirements).
The PRRC has to be an employee of the organization and it is possible to appoint more than one PRRC. Indeed, it is possible to split the obligations established by the Article 15 of the MDR 2017/745 between more PRRCs, provided that all the obligations laid down by the Article 15 are fulfilled.
Micro and small enterprises are an exception to the above, as they are “not be required to have the PRRC within their organization but shall have such person permanently and continuously at their disposal”.
Micro and small enterprises have the possibility of subcontracting the PRRC responsibilities to a third party that would be a single freelancer, or an employee of an external organization. In order to demonstrate and document the permanent and continuous availability of the external PRRC, it is fundamental for the manufacturer to establish a contract with the PRRC. In this contract should be mentioned the PRRC qualification in compliance with the requirements established in Article 15.
It is also advisable to point out the relevant obligations and responsibilities of the PRRC in the contract (especially if the manufacturer disposes of more than one PRRC). For micro and small enterprises are intended those with fewer than 50 persons employed and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million.
The MDR 745/2017 points out that the obligation of having a PRRC available within the organization refers to the individual legal manufacturer. This means that organizations with more than one legal manufacturer under the parent company need to ensure at least one PRRC for each legal manufacturer.
No obligations are specified as concerns the location of the PRRC, but it is fundamental a close linkage between the PRRC and the manufacturer activities. This means that it is suggestable to have the PRRC located in the same country of the manufacturer, therefore the PRRC could be located outside the EU in case of extra-EU manufacturer.
As for the micro and small enterprises, even the Authorized Representatives are not required to have the PRRC within their organization but shall have such person permanently and continuously at their disposal. Therefore, even the Authorized Representative may subcontract the PRRC responsibilities to a third party.
It should be highlighted that the PRRC and the Authorized Representative for an extra-EU manufacturer cannot be the same person and the PRRC of a micro/small enterprise and the PRRC of the Authorized Representative of that same enterprise shall not belong to the same external organization.
RPN is available for any clarification or support on this topic. Do not hesitate to contact us to receive more information!