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 MDR Regulation; (MDR-Chapter 1, Article 2)
All manufacturers outside the EU-Zone require a registered representative within the EU to apply for CE Marking. Authorized Representatives carry out specific tasks for registration/documentation and can be audited on behalf of the manufacturers.
Conformity assessment body means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; (MDR-Chapter 1, Article 2)
The activity of the product/process/organisation that is complying with the clauses of the standard or the requirement. Notified Bodies perform conformity assessments and grant certification as a proof/result of the conformity assessment.
Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between the national competent authorities and the European Commission. The public can access this portal in future to trace the information about products. (AdviQual Defnition)
Medical device regulation aims to ensure that patients have access to high-quality, secure, and efficient medical devices while preventing access to unsafe prepare products. Medical Device Regulation guarantees public health benefits and the protection of patients, health care staff, and the general public in the European Union. The latest European Medical Device Regulation (MDR) has been published in the Official Journal of the European Union. The MDR entered into force on 25 May 2017, marking the start of the transition period for manufacturers selling medical devices into Europe. (AdviQual Definition)
Notified Body means a conformity assessment body designated in accordance with MDR Regulation; (MDR-Chapter 1, Article 2)
The certification body that conducts conformity assessment at the manufacturers' facilities on behalf of the competent authority, usually the ministry of health. It depends on the classification of the product whether or not the involvement of NB is needed. Low-risk products-Class I do not require notified body involvement. All the other classes of products require notified body involvement and notified bodies to perform the CE Marking and Quality management System assessments and certify manufacturers.
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 MDR Regulation and other applicable Union harmonisation legislation providing for its affixing; (MDR-Chapter 1, Article 2)
This is the conformity assessment per relevant regulation on the product. It literally stands for European Conformity's french version Conformite Europeenne. All products: laptops, phones, ovens have to have a CE mark to pass the relevant safety level for the EU public. For medical devices, it also stands for market clearance; without CE Certification, a manufacturer cannot place their products on the EU market.
‘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, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-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; (MDR- Chapter 1, Article 2)
In vitro diagnostic medical devices (IVD) are tests used on biological samples (such as tissues, blood or urine) to determine the status of a person's health. Unlike medical devices or pharmaceuticals, IVDs never come into contact with a person. IVDs do not treat patients but provide information about the functioning of the body. IVDs do not cause direct harm but may pose risks if their use leads to an incorrect diagnosis. (AdviQual Definition)
‘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:
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.
The following products shall also be deemed to be medical devices:
Software as a Medical Device can be described as a medical software designed to carry out one or more medical functions without the need for actual hardware. (AdviQual Definition)
