Medical Device Regulation

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:

EitherOra 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 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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

This is not defined in the MDR. Please refer to the national regulations in the respective countries.

Yes, the MDR requires a prescription, so that the device can be categorised as a custom-made device. Please note that based on national provisions even CPO may be allowed to issue such prescription.

Yes, paperwork is still ok as long as all required contents is available. The MDR does not mention any format.

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.

Accessory for a medical device means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).

[EU-MDR Article 2 (2)]

CE marking of conformity or CE marking means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.

[EU-MDR Article 2 (43)]

Custom-made device means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

However, serial-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are serial-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices. [see EU-MDR Article 2 (3)]

• Custom Made devices are a special type of medical device

• All requirements for medical devices therefore apply to custom-made devices as well

• Exemptions are clearly highlighted by „except for custom-made devices“

• Custom-made devices are only the parts that are individually manufactured for a specific patient with specific specifications

Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease

• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability

• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state

• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means […].

[EU-MDR Aricle 2 (1)]

System means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose.

[EU-MDR Article 2 (11)]

Procedure pack means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

[EU-MDR Article 2 (10)]

Find detailed explanations about the following roles here :

• Authorised representative

• Distributor

• Health institution

• Importer

• Manufacturer

• Notified body

• Person responsible for regulatory compliance (PRRC)

Making available on the market means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

[EU-MDR Article 2 (27)]

Placing on the market means the first making available of a device, other than an investigational device, on the Union market.

[EU-MDR Article 2 (28)]

Putting into service means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.

[EU-MDR Article 2 (29)]