Introduction The current legal framework for medical devices in the European Union is based on the following Directives, adopted in the 1990s:
§ Directive 90/385/EEC, active implantable medical devices
§ Directive 93/42/EEC, medical devices
§ Directive 98/79/EC, in vitro diagnostic medical devices
These Directives have been implemented in the Member States by national legislation.
Since the adoption of these Directives, technology has not stood still. New methods and technologies have been introduced in the medical world, making it difficult for manufacturers to categorize their medical devices and knowing what rules are applicable for specific devices. Hence, the current legal framework for medical devices is outdated.
In this connection, the European Commission proposed new Regulations in 2012. After negotiations between the European Commission, the European Council and the European Parliament, the Regulation on medical devices1(“Medical Devices Regulation”) and the Regulation on in vitro diagnostic medical devices2(“IV Medical Devices Regulation”) were formally adopted on 5 April 2017. These regulations will replace the Directives and will apply after a transitional period of three years after publication of the Medical Devices Regulation and five years after publication of the IV Medical Devices Regulation.3 The main goal of these Regulations is to modernize the existing legal framework for medical devices based on the experience of the past few years and set a high standard for safety of the devices and their use throughout the European Union.
We will examine the implications of these Regulations in the European legal framework for medical devices. We will focus on the key changes the Medical Devices Regulation (hereinafter “Regulation”) will entail for the persons involved. The IV Medical Devices Regulation will not be analysed in specific detail, but, in general, the comments on the Regulation should also be borne in mind when dealing with in vitro medical devices.
First, we would like to draw your attention to the choice of a Regulation instead of a Directive. This means that, once adopted, the rules of the Regulation will apply directly in the Member States without having to be implemented in national legislation. As a consequence, the legal framework concerning medical devices has been unified throughout the Europe Union.
The key subjects affected by the regulations
The aim of this newsletter is to give an overview of certain new obligations, but its scope does not extend to an exhaustive elaboration of all modifications. The Regulation does not only contain new obligations for the manufacturer, but other actors in the supply chain (such as the distributor, the importer, etc.) will have specific obligations as well. It is thus important for all the actors in the supply chain to verify these new rules as they will have an impact on their obligations.
- Scope and definitions Even though the scope of the Regulation has not changed significantly, some devices that are not qualified as medical devices under the current legislation will be under the Regulation. For example, software is clearly considered as a medical device and the scope of “accessories to medical devices” that are subject to the Regulation is larger than under the Directive. The Regulation will also apply to products without an intended medical purpose (devices that only have an aesthetic purpose but that are similar to medical devices with regard to their characteristics and risks), such as coloured contact lenses that do not correct vision. A last example concerns products specifically intended for the cleaning, disinfection or sterilization of devices that are also considered as medical devices under the new Regulation. Furthermore, the definition of certain terms is also modified, having an impact on the scope. For example, “single-use device” is no longer a “device intended to be used once only for a single patient” but is now defined broader as a “device that is intended to be used during a single procedure”. It is thus very important for manufacturers to verify the scope as well as the definitions of the Regulation.
- Classification rules Medical devices are divided into four classes (I, IIa, IIb and III), according to their intended purpose and their inherent risks, with class I having the lowest risk. The classification criteria are set out in Annex VIII of the Regulation. The classification rules have been modified under the Regulation. This means that manufacturers are to verify under what class their medical devices are categorized. Some of the medical devices will be ranged in a higher class, meaning a stricter conformity assessment procedure. For example, active implantable medical devices and their accessories are class III by default.4 The Regulation adopts new specific rules for software. Software which drives a device or influences the use of a device falls within the same class as the device. If the software is independent of any other device, it is classified separately.
- Clinical investigation and evaluation The Regulation contains new provisions on clinical investigation and evaluation. Manufacturers wishing to place a medical device on the European market must submit stricter clinical evidence for their medical device. A device may be placed on the market or put into service only if it complies with the Regulation when it is duly supplied and properly installed, maintained and used in accordance with its intended purpose. The manufacturer must demonstrate the conformity of the medical device with the general safety and performance requirements by conducting a clinical evaluation. Apart from certain exceptions set out in the Regulation, implantable devices and class III devices are subject to a more thorough assessment in the form of a clinical investigation that must be authorized by the Member State. The procedure of the clinical investigation is elaborated by the Regulation and involves an assessment by an ethics committee. Furthermore, participants in the investigation must give their informed consent, and specific protective measures apply to vulnerable groups in the investigation, such as pregnant or breastfeeding women. This clinical investigation thus has some similarities to the procedure of clinical trials. Under certain conditions elaborated by the Regulation, a manufacturer can be exempt from conducting a new clinical investigation and can rely on the investigation of a related medical device. In general, manufacturers will have to adjust and be prepared to provide more elaborated clinical data concerning medical devices if they want to place their medical devices on the European market. They will also have to manage their medical devices post-marketing and verify their compliance with the Regulation frequently by establishing and updating a post-market surveillance system. This is even more so, since notified bodies will be allowed to conduct unannounced inspections.
- Transparency The Regulation contains new rules of transparency and traceability. A new system aiming to facilitate the traceability as well as transparency of medical devices will be implemented, namely the Unique Device Identification (“UDI”) system. This system will allow the identification, and facilitate the traceability, of devices, other than custom-made and investigational devices. The UDI will be placed on the label of the package of the medical device and will consist of (i) a UDI device identifier (“UDI-DI”) specific to a manufacturer and a device and (ii) a UDI production identifier (“UDI-PI”) that identifies the unit of device production and, if applicable, the packaged devices. The UDI will be stored by economic operators, health institutions and healthcare professionals. An electronic system for Unique Device Identification (“UDI database”) will be established. The UDI database will be integrated in Eudamed, the European database on medical devices. The public will be able to consult Eudamed, and thus be informed about clinical investigations.
The Regulation and the IV Medical Devices Regulation unify the legal framework for medical devices throughout the European Union. They are adapted to new technologies applied in the medical sector. Safety of these devices is clearly an important objective of the Regulation and will have an impact on the obligations of the manufacturer. However, certain aspects of the legal framework for medical devices are not addressed by the Regulation. For example, the rules concerning reprocessing single use medical devices are not harmonized. The Regulation does not provide specific obligations but states that reprocessing and further use of single-use devices may only take place if this is permitted by national law and only in accordance with the Regulation.5
The Regulation contains different new obligations for the manufacturer as well as others in the supply chain. For them to comply with the Regulation, the scope, definitions and specific obligations should clearly be analysed and implemented.