FAQ – Medical Devices Regulation (MDR)
Amends Medical Devices Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Under EU law, EU Directive has to be applied in member states through an implementing local or national laws or set of rules within the framework of that directive. Directives are not directly applicable in member states. There could be different versions of application and / or enforcement of the same directive in different countries. Some say directives create flexibilities for each country while others consider that they bring market complexities and non-level playing field for business.
EU regulation, unlike a Directive, is directly applicable in all member states at the same time unless otherwise indicated. Different parts of Regulation may come into force at staggered or different dates.
The Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC)
Though MDR was officially published on 5 May 2017 and came into force on 25 May 2017, Manufacturers and other relevant operators in the supply chain who have currently approved medical devices under the directive have a transition time of three years until 26 May 2020 to meet the requirements of the MDR.
MDR is directly applicable in all member states under the same timelines. Medical device manufacturers and distributors wanting to access the European Union (EU) markets will encounter major changes from the old regulatory framework, which was based on the directives and their various amendments. Some materials and equipment not previous regarded as medical device may come under the new classification and requirement. Manufacturers and other are required to check. Manufacturer outside the EU is required to appoint a representative a member state.
The definition has widened - 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. The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
For the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device
According to the MDR - a ‘manufacturer’ is 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.
Any natural or legal person established within the Union that places a device from a third country on the Union market.
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 until the point of putting into service.
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.
A manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3) of the MDR
Is defined as ‘making available on the market’ - 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
Refers to 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
The ability of a device to achieve its intended purpose as stated by the manufacturer.
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
Any healthcare professional or lay person who uses a device.
An individual who does not have formal education in a relevant field of healthcare or medical discipline.
A process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.
Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer
All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions
The activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.
A conformity assessment body designated in accordance with this Regulation,
An ‘adverse event’ is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device. While a ‘serious adverse event’ refers to any adverse event that led to any of the following: (a) death, (b) serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease.
A natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm are also regarded as nanomaterials.
Some of the changes may constitute significant changes for some manufacturers and other participants in the supply chain operation. The scope has broadened and manufacturer or persons in the supply chain would be well advised to examined their products to ensure that there are not caught by the new MDR though they might have been outside the requirements of the previous directive.