On this page, you can find information and links on topics that are important for the implementation of the regulations. However, this content does not target specific actors.
A 'custom-made device’ is made according to a written instruction by any person authorised by national law through their professional qualifications. This leads to specific design characteristics unique to that device. Said device is for the sole use of a particular patient and exclusively to meet their individual conditions and needs.
Mass-produced devices that are adapted to meet the specific requirements of any professional user are not considered custom-made devices. This includes adapted versions of devices that are mass-produced through industrial manufacturing according to written instructions by an authorised person.
See MDR Article 52(8) and annex XIII - procedure for custom-made devices
By 2020, the new EUDAMED database should be available. See our page on EUDAMED for more information and developments.
EUDAMED UDI device data dictionary. This document clarifies the data that you should provide to EUDAMED for the UDI device registration module.
These documents might still be subject to adjustments and fine-tuning and do not cover the legacy devices specificities.
The programme for the competitiveness of enterprises and small and medium-sized enterprises (COSME) is improving access to finance for SMEs through 2 financial instruments.
Health institutions should have the possibility to manufacture, modify and use devices in-house. Thereby, they address the specific needs of target patient groups on a non-industrial scale. This applies especially if these needs can't be met at the appropriate level by an equivalent device available on the market. With that in mind, certain rules of the Regulation should not apply since its aims would still be met proportionately (MDR and IVDR Article 5(5)).
This applies specifically to medical devices manufactured and used strictly in health institutions. Examples include hospitals, but also laboratories and public health institutes that support the healthcare system and/or address patient needs, but do not treat or care for patients directly.
The concept of ‘health institution’ doesn't cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption for health institutions doesn't apply to such establishments.
The Innovative Medicines Initiative (IMI) works to improve health by speeding up the development of, and patient access to, innovative medicines. Particularly, in areas where there is an unmet medical or social need. IMI does this by facilitating collaboration between key players in healthcare research, including
IMI is the world's biggest public-private partnership (PPP) in the life sciences. It's a partnership between the EU (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations). Through the IMI2 programme, there is a €3.3 billion budget for the period 2014-2020.
Under IMI2, MD or IVD manufacturers can become an IMI Associated Partner.
The Commission will make the CND nomenclature available, which will be mapped to the GMDN nomenclature to support the functioning of EUDAMED.
A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third party is required. The European Commission publishes a list of such notified bodies.
When an EU country informs the Commission and the other EU countries that a body has been designated to carry out conformity assessment according to legislation it's called notification. The notifying EU country is responsible for their withdrawal and notification of notified bodies.
Several documents related to the designation of notified bodies under the new regulations were adopted by the medical devices coordination group.
Software and mobile applications that fall under the definition of a medical device or an in-vitro diagnostic medical device are regulated by the respective Directives 93/42/EEC or 98/79/EC. See the texts on Directive 93/42/EEC and Directive 98/79/EC
In the context of borderline cases, the MEDDEV Guidance 2.1/6, entitled 'Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices' and released by the Commission services in January 2012 (and updated in July 2016), is the most relevant document which provides practical advice to manufacturers, organisations and public authorities on how to determine when a software falls under the definition of a medical device or of an in-vitro diagnostic medical device. Such criteria apply also to mobile applications. See guidance.
Please note however the qualification and classification issues rely primarily on EU countries.
Should your mobile application be regulated by one of the mentioned directives, you, as the manufacturer, with a view to affix the CE mark, would then be required to follow the appropriate conformity procedure. Such procedure may require, according to the device risk class, an application to one of the notified bodies recognised by the EU. For class I devices, however, a self-declaration is sufficient.
Please note finally the legislative framework on medical devices has been revised and 2 new regulations were adopted and will become progressively applicable until 2020 and 2022. The new rules contain dedicated requirements have been set for medical software, apps, cybersecurity.
The unique device identification (UDI) is a unique numeric or alphanumeric code pertaining to a medical device. The UDI has 2 parts
These provide access to useful information about the device. The specificity of the UDI
The UDI will be an addition to, not a substitute for, the existing labelling requirements for medical devices.
The EU, as chair of the International Medical Device Regulators Forum (IMDRF) working group on UDI, has strongly contributed to the preparation of the international guidance on a unique device identification (324 kB) (UDI) system for medical devices, which was adopted in December 2013.
The Commission issued a recommendation in April 2013 on a common framework for a unique device identification system for medical devices in the EU. This was intended to provide the basis of the EU’s future identification and traceability infrastructure, in line with the latest developments at international level.
The new medical device regulations introduce the unique device identification (UDI) system based on a unique device identifier.
The new UDI system will facilitate easier traceability of medical devices, significantly enhance the effectiveness of the post-market safety-related activities for devices and allow for better monitoring by competent authorities. It will also help to reduce medical errors and to fight against falsified devices. The use of the UDI system finally should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators.
The new system will be applied to all medical devices placed on the EU market except custom-made devices and is based on internationally recognised principles including definitions that are compatible with those used by major trade partners.
Article 27 of the 2017/745 and Article 24 of Regulation 746/2017 lay down that the UDI system shall consist
In accordance with the new rules, any manufacturer before placing a device on the market shall assign to the device and to all higher levels of packaging a UDI. The UDI carrier shall be placed on the label of the device and on all higher levels of packaging. Before a device is placed on the market the manufacturer shall ensure that the information – related to the device in question - referred to in Part B of annex VI of the 2 regulations is correctly submitted and transferred to the UDI database.
Within the EU, the manufacturer shall assign to his devices, together with a UDI, also a Basic UDI-DI. The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) and will also be the access key for device-related information entered in future European medical device database.
UDI issuing entities to be designated by the European Commission provide the manufacturer with a list of UDIs that it can then assign to his products. The European Commission will designate the entities by the second quarter of 2019.