The new Medical Devices Regulation (2017/745/EU) (EU MDR) will replace the existing Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). The EU MDR was published in May 2017, marking the start of a three-year transition period. This EU MDR factsheet is intended for manufacturers of medical devices and medical software. It will help to get a quick overview of the main changes and the relevant implementation steps.
Changes by EU MDRIn terms of their impacts on manufacturers and products, the directives and the EU MDR largely share the same basic regulatory requirements. No existing requirements have been removed, but the EU MDR adds new requirements.
- Compared to the current Directives, the EU MDR places more emphasis on a life-cycle approach to safety, backed up by clinical data. The EU MDR brings more stringent requirements for the designation of Notified Bodies, with increased control and monitoring by the national competent authorities and the Commission.
- The EU MDR reclassifies certain devices and has a wider scope. For instance, it explicitly covers all devices for cleaning, sterilizing or disinfecting other medical devices (Article 2.1); reprocessed single-use medical devices (Article 17); and certain devices with no intended medical purpose (Annex XVI).
- The EU MDR also covers internet sales of medical devices and medical devices used for diagnostic or therapeutic services offered at a distance (Article 6).
- The EU MDR introduces a clinical evaluation consultation procedure for some Class IIb devices and for implantable Class III devices by an independent expert panel (Article 54).
- A new unique device identification (UDI) system (Article 27) will significantly enhance the traceability and the effectiveness of post-market safety-related activities.
- The EU MDR will also provide increased transparency, with information on devices and studies being made public. Here, the new European Database for Medical Devices – EUDAMED – will play a central role in making data available and increasing both the quantity and quality of data (Article 33).
Scope of EU MDRThe scope of the EU MDR (Article 1) has broadened. Hence, as a manufacturer you must check your product portfolio to find out whether more of your devices fall within the scope of the Regulation compared to the Directives. Pay attention to products listed in Annex XVI, which will be covered by the Regulation once the respective implementing regulation setting out common specifications has been adopted. The list of products excluded from the scope can be found in paragraph 6. Some products that combined a medical device and an in-vitro diagnostic device or a medicinal product follow specific rules (see paragraphs 7, 8, 9). Moreover, it is now explicit that devices and services sold online fall under the scope of this Regulation (Article 6).
Definitions in EU MDRThe definition (Article 2) of a medical device has been slightly modified and there are more definitions of terms in the Regulation than in the Directives, in order to ensure a common understanding at EU level. Examples include: unique device identifier (Definition 15), clinical data (Definition 48), clinical evidence (Definition 51), and serious incident (Definition 65).
Obligations of ManufacturersAccording to Article 10, manufacturers shall
- have systems for risk management (paragraph 2),
- have systems for quality management (paragraph 9),
- conduct clinical evaluations (paragraph 3),
- compile technical documentation (paragraph 4),
- apply a conformity assessment procedure (paragraph 6).
Risk Classes of DevicesAs a manufacturer you must check your portfolio of products to determine whether some of your devices will be reclassified or will need to be scrutinized by a Notified Body. Determining the risk class of a medical device is essential in specifying the steps required for CE marking (Article 51), especially in terms of the choice of conformity assessment procedure and clinical requirements. Besides, the EU MDR sets out 22 rules for determining risk classes (Annex VIII), compared to 18 rules under the Directive. You should pay special attention to rules regarding: invasive devices, surgically invasive devices and implantable devices (Section 5, Rules 5 to 8); active devices (Section 6, Rules 9 to 13, for example, software now falls under Rule 11); devices utilizing tissues and cells (Rule 18); devices incorporating nanomaterials (Rule 19); and devices composed of substances (Rule 21).
Notified BodiesNotified Bodies have to be designated under the new Regulation. They will be required to meet more stringent criteria, particularly in terms of clinical competence. Notified Bodies can apply to be designated from 26 November 2017. The process of designation, which might take 12 months or more, involves assessors from different national and European authorities. This means that the first Notified Bodies designated under the new Regulation might be available by the end of 2018. Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive. Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State. The database of Notified Bodies for medical devices can be found here. As a manufacturer you must verify whether your Notified Body will be designated under the new Regulation and whether the scope of its designation will cover all your products. You must also start working with your Notified Body to plan the timing of certification for your product portfolio, taking into account the availability of your Notified Body, the need for additional data on devices and the transitional provisions in the new Regulation.
Device IdentificationA system of unique device identifiers (UDIs) will enhance the identification (Article 27) and traceability (Article 25) of medical devices. This is a completely new feature of the Regulation. Each medical device – and as applicable, each package – will have a UDI composed of two parts: a device identifier (UDI-DI) specific to a device, and a production identifier (UDI-PI) to identify the unit producing the device. Manufacturers are responsible for entering the necessary data on the European database (EUDAMED), which includes the UDI database, and for keeping it up to date.
Conformity AssessmentThe assessment of the conformity of a device for CE marking (Chapter V Section 2) varies according to the risk class and specific features of certain devices (Article 52). The intervention of a Notified Body is needed for all class IIa, IIb and III devices, as well as some specific class I devices (see paragraphs 7a, b, and c). These are:
- devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions,
- devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements,
- reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
Clinical RequirementsThe new regulation reinforces the requirements for clinical evaluation (Chapter VI, Article 61), introducing some of the biggest changes compared to the previous regime. As under the directives, it includes the collection of clinical data already available in the literature as well as the setting up of any necessary clinical trials (in the EU MDR called “clinical investigations”). The concept of equivalence with other devices for which clinical data already exists can still be used, but only in a limited number of situations, and the new rules are tighter (Article 61 paragraphs 4, 5, 6). Article 62 and Annex XV set out the new and more precise requirements for clinical trials. With only certain exceptions, implantable and class III medical devices must now go through clinical trials. For all class III devices, and for class IIb devices intended to administer a medicinal product (or remove it from the body), the manufacturer has the option to consult a group of European experts to obtain an upstream review of its intended clinical development strategy (Article 61 paragraph 2).
Summary of Safety and Clinical PerformanceFor class III and implantable devices, manufacturers shall draw up a summary of their safety and clinical performance in a form that intended users (and patients, if relevant) can understand (Article 32). This summary will form part of the technical documentation sent to the Notified Body.
TimelineDuring the transition period the EU MDR will come into force gradually, starting with the provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the EU MDR. The transition period will end on 26 May 2020, the date of application of the Regulation. From that date the MDR will apply fully. To avoid market disruption and allow a smooth transition from the Directives to the regulation, several transitional provisions are in place (Article 120). Some devices with certificates issued under the Directives may continue to be placed on the market until 27 May 2024 (Article 2 paragraph 282), and made available until 27 May 2025 (Article 2 paragraph 27). During the transition period, products certified under the Directives and products certified under the Regulation will coexist on the market. Both will have equal status under the law, and no discrimination in public tenders may take place. As a manufacturer, the timing of your transition to the EU MDR is up to you. From 26 May 2020, all new certificates will have to be delivered according to the Regulation. With some exceptions (Article 120 paragraph 2) the certificates delivered under the Directives can be valid until their date of validity for a maximum of four years (27 May 2024 at the latest). However, in the latter case, the requirements of the new Regulation relating to post-market surveillance, market surveillance, vigilance, and the registration of economic operators and devices shall apply from 26 May 2020 (Article 120 paragraph 3). Class I devices (other than those that have a valid certificate under the Directive) will have to conform to the new Regulation from 26 May 2020. Class I (except sterile devices, devices with a measuring function and reusable surgical instruments) and class IIa might be easiest to start with. Classes IIb and III will be more challenging because of the more stringent requirements for clinical data.
Practical ImplementationAs a manufacturer, you can start now by making sure that:
- all your products are classified appropriately
- all product documentation and evidence of compliance will be available in a timely fashion and conforms with the EU MDR and
- you have the necessary systems in place to handle clinical evaluation, quality management, post-market surveillance, and liability for defective devices.