Relevant economic operators

For an overview of the different roles and responsibilities, the corresponding definitions, subcategories and further information are found here. The person responsible for regulatory compliance (PRRC) in particular is examined in detail.

The new Medical Device Regulation (MDR) requires the appointment of a "person responsible for regulatory compliance" (PRRC).

The following must appoint a PRRC

  • Manufacturers (of serial and custom-made devices)

  • Authorised representatives

  • Importers, distributors or other persons, if the obligations of the manufacturer apply to them

Note: Importers and distributors are not required to appoint a PRRC, if no obligations of a manufacturer apply to them.

Responsibilities

The PRRC shall at least be responsible for ensuring that:

  • the conformity of the devices is appropriately verified 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;
  • the reporting obligations (reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions, analysis of vigilance data) are fulfilled;
  • in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV applies.

Internal or external PRRC?

Manufacturers, including manufacturers of custom-made medical devices, shall have available within their organisation "at least one person responsible for regulatory compliance." This means it should be an internal PRRC.

Note: Micro and small enterprises “shall have such a person permanently and continuously at their disposal”. This exemption allows the appointment of an external PRRC for micro and small enterprises.

The MDR defines micro and small enterprises as follows:

  • Micro enterprise: fewer than 10 employees and annual revenue less than € 2 million.

  • Small enterprise: fewer than 50 employees and annual revenue less than € 10 million.

Qualification of the PRRC

The PRRC must possess the requisite expertise in the field of medical devices, which shall be demonstrated as follows:

EitherOr
a diploma, certificate or other evidence of formal qualification in law, medicine, pharmacy, engineering or another relevant scientific disciplinefour years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
and
at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
Note: Manufacturers of custom-made devices may demonstrate the requisite expertise by having at least two years of professional experience within a relevant field of manufacturing.

Appointment of the PRRC

The appointment of the PRRC must be made in writing. Depending on your role as economic operator, you can select the respective template for the appointment letter here.

Authorised representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation."

Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up to the point of putting it into service."

As distributor, you have to check the devices for the following aspects:

  • CE marking is applied

  • Declaration of conformity is available

  • Necessary information is supplied with the device (e.g. instructions for use)

  • Unique device identifier (UDI) is available (relevant by 2025)


Furthermore, your responsibilities include:

  • Follow storage or transport conditions outlined by the manufacturer.

  • Record information regarding complaints, non-compliance and incidents and forward them to the manufacturer.

  • Work together with competent authorities if requested.

  • Document which devices were bought and sold (traceability of the device).


Note: Patient names do not need to be traced, but other economic operators do.

Health institution means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health." [EU-MDR Article 2 (36)]

Based on this definition, patient care providers could be considered a health institution.

If products are used in a health institution, they are considered as being "placed on the market".

Importer means any natural or legal person established within the Union that places a device from a third country on the Union market."

Manufacturer

Manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

As a patient care provider, you can provide your patients either with a serial medical device or a custom-made medical device that has been individually manufactured for that particular patient. It is necessary to distinguish between these two types of products in order to know which requirements of the MDR apply to you.

The effort required to be a manufacturer of serial medical devices is much greater than for custom-made medical devices.


Manufacturers of serial medical devices

The MDR specifies the following obligations for manufacturers of serial medical devices:

  • A full quality management system according to Article 10 must be implemented.

  • There must be a written declaration of conformity as well as a technical documentation.

  • The devices must be marked with the CE marking of conformity.

  • There must be a person responsible for regulatory compliance (PRRC).

  • Economic operators that devices were received from or supplied to must be identified.


Manufacturers of custom-made medical devices

The MDR specifies the following obligations for manufacturers of custom-made medical devices:

  • A statement according to Annex XIII must be drawn up for the custom-made device and according to Article 22 for the patient solution.
  • Devices must be marked as "custom-made device".

  • There must be a person responsible for regulatory compliance (PRRC).

  • Economic operators that devices were received from or supplied to must be identified.

  • The following processes must be implemented:
    • Risk management
    • Clinical evaluation
    • Post-market surveillance (PMS)
    • Vigilance

Notified body means a conformity assessment body designated in accordance with this Regulation.

Notified bodies are state-authorised bodies that – depending on the product and its risk class – carry out tests and assessments within the framework of the conformity assessment to be carried out by the manufacturer and certify its correctness according to uniform assessment standards.