This topic gathers information and links on issues that are relevant for the implementation of the Medical Devices Regulation (MDR). Therefore, the number of areas is vast. In addition, the content does not target specific actors.
The so-called borderline products are those for which it is not clear whether they fall under the medical devices legislation or another piece of legislation.
These cases are of great concern to EU countries, the European Commission and other stakeholders since they can lead to different interpretations within the EU, and as a consequence, may put public health at risk and distort the single market.
To ensure a uniform approach, the Commission tries to facilitate a dialogue between regulators and industry, where diverse interpretations exist.
Background note on the use of the Manual on borderline and classification for medical devices under the Directives.
Counterfeiting of health products is a serious and growing concern, since this practice endangers patients’ safety and health. A counterfeit medical device is one which is deliberately and fraudulently mislabelled with respect to identity and source. The EU’s combat against counterfeiting is part of a general regional and international effort to offer authentic devices to populations.
The consequences of counterfeiting are numerous.
- Health and safety: Counterfeit medical devices can have adverse effects, including potentially lethal consequences, as they are often non-sterile, of poor quality, contain inappropriate materials and be of questionable effectiveness
- Economic: Counterfeit medical devices distort competition, damage legitimate producers’ interests and their brand names, undermine employment and reduce tax income. Manufacturers can experience loss of sales and see their reputation tarnished if the counterfeit medical device uses their company’s trademark.
The Commission issued a study on distribution channels dealing with counterfeit issues. The goal is to assist and encourage the development and implementation of government policies and regulations that combat and dissuade the production and trade of counterfeit medical devices.
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. Such a 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.
European Medical Devices Nomenclature
The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.
Founded on pre-established criteria and requirements and based on orientations provided by the Medical Device Coordination Group (MDCG), the European Commission decided in favour of the use of the ‘Classificazione Nazionale Dispositivi medici’(CND) as the basis for the EMDN.
The first version of the EMDN is integrated in EUDAMED and is fully available in the EUDAMED public site.
The programme for the competitiveness of enterprises and small and medium-sized enterprises (SMEs), COSME, is improving access to finance through 2 financial instruments.
In-house medical devices
Health institutions 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 cannot 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 In Vitro Diagnostic Regulation, 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’ does not 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 does not apply to such establishments.
A notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before being placed on the market.
Software and apps
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 most relevant document is 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”. Released by the Commission services in January 2012 (and updated in July 2016), the document 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 also applies to mobile applications.
Please note that addressing qualification and classification issues rely primarily on EU countries.
Should the mobile application be regulated by one of the mentioned directives, 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-assessment is sufficient.
The legislative framework on medical devices has been revised and 2 new regulations will become progressively applicable until 2021 and 2022. The new rules contain dedicated requirements for medical device software, apps, cybersecurity and clinical and performance evaluation.
In the context of borderline cases under the Regulations and further information on medical device software, please refer to guidance on MDCG 2019-11, entitled Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR'.