Medical Device Regulation

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

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.

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)]