The EU’s Medical Device and In Vitro Medical Device Regulations – What Will Change?
The EU legislation in the field of medical devices has undergone a transformation as a result of the publication of the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation. What are the main changes introduced by the new Regulations that will be directly binding on all EU member states?
The Medical Device Regulation (2017/745) and In Vitro Diagnostic Medical Device Regulation (2017/746) were published on 25 May 2017. The rules of the MDR will apply as of 26 May 2020, whereas the rules of the IVDR will apply as of 26 May 2022.
Broadened concept of a medical device
The MDR broadens the definition of a “medical device” by including in the definition devices that provide data through in vitro examination of human specimens as well as products that are intended for cleaning, disinfecting or sterilizing medical devices. The extended concept of a medical device also includes certain products without an intended medical purpose listed in Annex XVI of the MDR. Such products include contact lenses, liposuction equipment and epilation lasers.
Reclassification and recertification of devices
Devices under the MDR and the IVDR are classified based on risks associated with the device in question. For class I medical devices and class A in vitro diagnostic medical devices, self-assessment of the device’s conformity is sufficient, provided that the device is not sold as sterile or has a measuring function. Conformity assessment of class II a, II b and III medical devices as well as class B, C and D in vitro diagnostic medical devices requires the approval of a notified body. The device may be CE marked only after it has passed the conformity assessment procedure.
In addition to new devices, the Regulations require recertification of devices already on the market. Therefore, all currently approved devices must be recertified in accordance with the new requirements. In practice, this means that many devices will be reclassified with a higher risk classification than before. If more than one classification rule apply, the one with the highest risk class outcome should be chosen.
Improved traceability and transparency through UDIs and EUDAMED
The Regulations provide for a Unique Device Identification (“UDI”) system that applies to all devices, excluding custom-made and performance study/investigational devices. Manufacturers have to affix a unique UDI code to the label or packaging of each device before placing the device on the market. The UDI system enables devices placed on the market to be identified and traced, thus allowing for better monitoring by competent authorities and reporting of serious incidents.
Information about UDIs is published in the European database on medical devices (EUDAMED), which is intended to be accessible to the public in spring 2020. EUDAMED, which is maintained by the European Commission, includes information about devices placed on the market, their certificates, economic operators and clinical investigations as well as serious incidents linked to the devices.
More obligations for economic operators
The MDR and the IVDR also set out a number of new obligations for all economic operators (including, in addition to manufacturers, authorized representatives, importers, and distributors). They also better distinguish the roles of operators in terms of e.g. the provision of technical documentation, labeling, filing complaints and post-market surveillance. While manufacturers are primarily responsible for all processes, the obligations can under certain circumstances be transferred to e.g. the distributor or importer.
In terms of new obligations imposed on manufacturers, the MDR and the IVDR require manufacturers to maintain technical documentation available for an extended period of time, and maintain systems for risk and quality management for all devices. Manufacturers, excluding micro and small enterprises, are also required to have a person responsible for regulatory compliance available within their organizations. The responsibilities of this person include, at a minimum, ensuring that the manufacturer’s obligations pertaining to ensuring device conformity, compilation and updating of technical documentation, post-market surveillance and reporting are complied with.
Safety assessment throughout the life cycle of the device
The clinical evaluation provisions in the MDR and the IVDR illustrate a shifted focus from mere device approval to the entire device lifecycle. While the Regulations set out more specific requirements for clinical evaluations and their documentation, the evaluation and associated documentation must be updated throughout the life cycle of the device.
The focus on a continuous evaluation and improvement cycle is also reflected in the provisions regarding post-market surveillance. Manufacturers must have a post-market surveillance system for each device that is proportionate to the risk class and appropriate for the type of device. This includes proactively monitoring device performance for recertification, annual safety updates for higher risk class devices, and rapid reporting of safety incidents. Manufacturers must also have a post-market surveillance plan available as part of their technical documentation, with information concerning for example serious incidents, trend reporting and complaints. Increased reporting obligations means that all manufacturers will have to compile either post-market surveillance reports or periodic safety update reports, depending on the risk classification of the device.
Also, the vigilance provisions are more rigorous under the new regulations. Serious incidents must be reported no later than 15 days after the manufacturer became aware of the incident, in comparison to the 30 days reporting time that was permitted previously. Implemented field safety corrective actions must also be reported, and manufacturers must conduct a separate analysis of serious incidents and the field safety corrective actions they have taken. The Regulations also introduce a new obligation relating to trend reporting, as manufacturers are required to analyze and report statistically significant increases in non-serious incidents.
The MDR and the IVDR introduce substantial changes to the regulatory framework in the field of medical devices that in its current form dates back to the 1990s. They play an essential role in ensuring that both patients and public health remain protected while at the same time securing access to innovative technology that offers new diagnostic and therapeutic opportunities.
By providing a new approach through checklist-like requirements and harmonized European standards, the MDR and the IVDR place significant obligations on economic operators in the medical device industry. Indeed, companies should not delay in preparing for the full application of the regulations by e.g. securing appropriate levels of expert resources to ensure compliance. Early preparations are also likely to give companies a competitive advantage and minimize certification bottlenecks in the run-up to May 2020 for the MDR, and 2022 for the IVDR.