iThe EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance for medical devices within the European Union, and have far-reaching consequences for the life sciences industry.
IN DEPTH
The new EU Medical Device Regulation (MDR) (2017/745) will enter into application on 26 May 2020. It was published on 5 May 2017, following a years-long revision process. Published the same day as the MDR, the In Vitro Diagnostic Medical Device Regulation (IVDR) (2017/746) is set to enter into application on 26 May 2022.
The Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), which constituted the previous regulatory framework for medical devices in the European Union, are repealed with effect from 26 May 2020, with a few exceptions.
The new Regulations bring about a long-awaited change in legislation. Medical devices represent a key industry in the European Union: more than 500,000 medical devices are currently in circulation in Europe, encompassing a broad range of products and generating about EUR 100 billion in annual sales. The previous Directives have been in place for more than 25 years and have proven insufficient to address the considerable technological transformation of the medical device industry. The 2012 PIP implant scandal further highlighted the need for market vigilance and transparency, including public access to information.
The MDR has far-reaching consequences for the industry. It sets out new and far more stringent requirements for medical devices, which will affect clinical evaluation, conformity assessment procedures, traceability and market surveillance, among other obligations. Considering the significance of these changes and the operational issues they raise, there is widespread concern in the industry that many actors will be unable to fully comply with the MDR by the general date of application. This could negatively affect the availability and safety of medical devices in the European Union.
Broader Scope, Stricter Requirements for Medical Devices
The MDR expands the scope of the regulation to include previously unregulated products. According to Annex XVI, several devices with a solely aesthetic purpose, such as coloured lenses with no corrective property, will be regulated by the MDR. However, live bacteria such as probiotics are expressly excluded from the scope of the MDR.
The MDR maintains the classification system currently in place under the Directives: medical devices are classified according to risk, from Class I (low risk) to Class III (high risk). Higher risk and implantable devices are the most affected by the requirements introduced under the MDR.
The MDR increases the number of rules and criteria used to determine the risk class of a medical device. Many medical devices will be “upclassified” under the new Regulation, i.e., moved to a higher risk class, with more stringent requirements at every stage, from ex-ante control to post-market surveillance.
The treatment of medical software under the MDR exemplifies both the expansion of the scope of the regulatory framework to reflect the state of innovation, and the imposition of heightened requirements. The MDR explicitly distinguishes between software—including apps—that serves a medical purpose and is thus considered a medical device, and software that serves a general purpose and is not considered a medical device, even when used in a healthcare setting. Typically, general fitness, lifestyle and wellness apps fall outside the scope of the MDR. In case of uncertainty, the functionality of the software, the manufacturer’s intention and any marketing claims regarding health benefits will be taken into account to determine whether the software should be regulated as a medical device. Even if a software product is not defined as a medical device, it might be considered an accessory to a medical device and therefore be subject to specific requirements under the MDR.
Many medical software products likely will be moved to a higher risk class, with stricter requirements. Moreover, many other software that were altogether unconcerned by previous EU medical laws will now be considered medical devices. Manufacturers will have to set up risk assessment procedures accordingly. The MDR outlines specific IT security measures for medical software in addition to the general requirements dependent on risk class. The EU issued guidance on cybersecurity requirements for medical devices earlier this month.
Potential Operational Difficulties for Industry Actors
The MDR places new and stricter requirements onto existing actors, and also defines new actors. It introduces the Medical Device Coordination Group, which is tasked with assisting the Commission and member states with MDR implementation, and a person responsible for regulatory compliance, which will need to be appointed by manufacturers. It increases the responsibilities of national control authorities, outlines an EU-wide procedure for multi-centre clinical investigation and strengthens the role of experts. It also clarifies the obligations of four economic operators for medical devices: the manufacturer, the authorised representative, the importer and the distributor.
Together with notified bodies, manufacturers of medical devices will be the most affected by the new rules. Under the previous Directives, manufacturers already bore the most responsibilities, and they will need to meet stricter and new requirements regarding technical documentation, labelling, risk management and clinical evaluation to comply with the MDR. They will have to follow more restrictive CE marking procedures for many devices, collect data about device performance after a product is placed on the market, and update their documentation and processes accordingly, with insufficient guidance from the European Commission so far. Manufacturers of implantable devices will also have to issue an “implant card” containing information about these devices. Many manufacturers will likely struggle to fulfil all of their obligations by 26 May 2020, fuelling concerns some might decide to withdraw from the European market altogether.
Notified bodies also face considerable challenges under the MDR. Manufacturers can only self-certify Class I devices. For any medical device of a higher risk class, a notified body must assess the product before it can receive a CE mark and be placed on the European market.
Under the MDR, much stricter rules apply to notified bodies regarding their control, oversight and evaluation missions. This represents a shift in the way notified bodies must carry out their obligations. While they previously took on a more consultative role, notified bodies will effectively enforce the new Regulation. Crucially, the MDR and the IVDR establish both the right and the obligation for notified bodies to conduct unannounced audits. This shift is likely to affect the compensation liability of notified bodies.
The MDR requires notified bodies to reapply for their status, even if they had already been approved under the Directives. Only nine notified bodies are currently designated under the MDR, with none in France so far. This is far below the approximately 20 notified bodies that the Commission expected by the end of 2019, or the 58 that held their status under the Directives. Stricter requirements, as well as the increased number of medical devices affected, have prompted several former notified bodies to announce that they would not seek designation under the MDR.
Many manufacturers will have to switch to a notified body that has received its designation under the MDR. These manufacturers will have to undergo an audit and have all their documentation reviewed by their new notified body before it can assess their products. Additionally, manufacturers will have to seek certification for thousands of upclassified medical devices they could previously self-certify.
Even if the Commission designates a dozen more notified bodies by 26 May 2020, they are unlikely to have sufficient capacity to handle the increased workload. This will lengthen the already months-long process for certification or recertification of new and existing products, thus delaying the market availability of many medical devices.
A Complex and Shifting Calendar for Application of the MDR
The MDR contains several exceptions to the general date of application of 26 May 2020. The Regulation provides for several interim phases for Eudamed, a comprehensive new database on medical devices and a key feature of the new legislation. Eudamed will store all the regulatory information relevant to a device, including a unique identification number, its manufacturer and distributors, clinical evaluation data and any certificate issued by a notified body.
The Commission announced in October 2019 that Eudamed would not be fully functional for another two years. Pursuant to the MDR, Eudamed-related interim phases will not start until notice of full database functionality is issued. The duration of interim phases varies depending on the action concerned.
MDR obligations are only postponed insofar as they relate to Eudamed. For example, manufacturers must still designate a person responsible for regulatory compliance by 26 May 2020, even though that person will not be registered until Eudamed is fully functional.
A few MDR provisions applied before the general date of application, including, for instance, provisions concerning the Medical Device Coordination Group. Several derogations apply to MDD/AIMDD-compliant devices, allowing for different transition periods depending on the risk class of the device and its situation on the market. A grace period applies to certificates issued by notified bodies before 26 May 2020. Existing medical devices with a certificate may continue to be placed on the market until 26 May 2024, provided that they remain compliant with the Directives and there is no significant change in their design or intended use. Whether a change is significant will mostly be determined on a case-by-case basis.
Pursuant to a “warehousing provision”, MDD/AIMDD compliant devices that are placed on the European market before 26 May 2020 or hold certificates issued before 26 May 2020 and benefitting from the aforementioned grace period may continue to be made available until 26 May 2025. This does not apply to the placing on the market of such devices or to second-hand sales.
The European Union recently published corrigenda meant to further alleviate the difficulties faced by the medical device industry with regard to the application of the new rules. Most notably, a corrigendum published in December 2019 allows for a four-year grace period before upclassified Class I devices must receive a certificate issued by a notified body designated under the MDR. Other changes in the calendar are unlikely.
Transition periods for MDD/AIMDD-compliant devices only relate to certification requirements. Other obligations for these devices—such as risk and quality management or clinical evaluation requirements—come into effect on 26 May 2020.
Manufacturers likely will be unable to use these exceptions to their full extent, because notified bodies will not have enough capacity to put all existing certificates through the grace period in the next four months. Class I devices that are not moved to a higher risk class do not benefit from any transition period. Even if manufacturers wish to take advantage of the warehousing provision, they might be unable to do so because of limited production capacities or a product’s short shelf life.
Post-Brexit Uncertainties
The British Parliament has officially passed the EU Withdrawal Bill. Following the approval of the Withdrawal Agreement by the European Parliament on 29 January 2020, the United Kingdom will remain bound by EU laws until 31 December 2020. The MDR will apply in the United Kingdom from 26 May 2020 until the end of this transition period. During this time, the United Kingdom and the European Union will start negotiations on a future trade agreement. The United Kingdom and the European Union may decide to extend the transition period by up to two years; such an extension must be agreed upon before 1 July 2020.
Considering the short timeframe for negotiations in the absence of an extension, there is a distinct possibility that the United Kingdom and the European Union may fail to reach an agreement before the end of the transition period. In this case, the United Kingdom would not be able to continue its participation in the EU regulatory network for medical devices, UK-based notified bodes would lose their designation, and their certificates would become void, among other consequences. The United Kingdom took steps to ensure that its rules for medical devices closely mimic those set out by the MDR in the event of a no-deal Brexit, but it might decide in the future to impose different regulatory requirements.
Even if there is an agreement, it is unlikely that UK-based notified bodies will keep their status in the European Union. UK-based manufacturers may need to have an EU27-based representative and an importer as early as 31 December 2020 if they wish to continue placing their devices on the European market. Future requirements for placing devices on the UK market are less clear but will likely involve a UK responsible person and an importer.
