In May 2017, the European Medical Devices Regulation (MDR), approved by the European Council and European Parliament earlier that year, came into force, setting the stage for its application. Initially set as May 26, 2020, the MDR DoA was postponed one year in April 2020 in response to the COVID-19 pandemic.
The regulation was introduced to address a number of weaknesses in the existing regulations (the Medical Device Directives, or MDD); the primary goal is to boost the safety and effectiveness of all commercialized medical devices.
This article explains the MDD’s shortcomings, details the MDR’s history, highlights expected transition timelines, describes the most significant changes resultant of MDR, and discusses the anticipated impact on medical device markets.
The MDD’s Shortcomings
Adopted in the early 1990s, the MDD are composed of three directives: the Supplementary Directive for In Vitro Devices, the Supplementary Directive for Implantable Devices, and the Primary Medical Device Directive. Although the MDD served their purpose well and played a significant role in the success of the European medical device market over the past three decades, the Directives’ weaknesses have rendered them somewhat ineffective in today’s medtech world:
- Outdated regulations: The MDD did not keep up with technological developments (and the regulatory challenges they incur) in the medical device space, particularly as it relates to hybrid devices and medical software.
- Lack of consistency: Because the MDD were directives (as opposed to regulations), they did not supersede the laws of individual countries; as a result, there was some variation in how they were implemented across the various member states.
- Focus on approval, not postmarket performance: Following approval under the MDD, device performance was not tracked in a particularly useful or accessible way, and continued clinical assessment was not mandatory.
- Narrowly focused accountability: Liability for device issues and failures fell on the original manufacturer, without accounting for other companies in the supply/distribution chain; this led to a lack of accountability for other parties involved in the supply of medical devices.
- Insufficient scrutiny on notified bodies: Notified bodies had (NBs) focused on one-time/premarket assessments and approval, behaving as industry partners for manufacturers, focusing on approval rather than device safety and quality.
In 2002, the Medical Device Expert Group (MDEG) issued a report identifying a number of weaknesses in the MDD; in particular, the MDEG found that, while the MDD represented a suitable legislative and legal basis for regulating medical devices, its implementation was lacking in many avenues, including the consistency and reliability of conformity assessments, general transparency in regulatory processes, and postmarket surveillance practices.
As a result of the report, numerous modifications were made to the MDD, including the inclusion of a specific definition for clinical data and expanded articles on conformity assessments. The emergence of the PIP breast implant and MOM hip implant scandals in 2010 placed immense pressure on the EU commission to implement changes and rejuvenated calls for regulation reform. Ultimately, following various consultations and amendments, the European Commission approved and released the text of the new regulations in 2017.
While the MDR’s date of application was initially set for May 26, 2020, the European Council and European Parliament approved a one-year delay to MDR DoA on April 24, 2020, pushing the DoA to May 26, 2021 to enable industry stakeholders to focus their efforts and resources on the COVID-19 response. Reacting to the pandemic, medical device manufacturers and regulators have been presented with unprecedented challenges, such as meeting substantial demand for specific products (e.g., personal protective equipment) and enabling or conducting on-site audits when movement restrictions are in place.
It is important to note that transitional periods have not changed as a result of this delay; regulatory certificates issued under the MDD before May 2017 will remain valid until they expire, or through May 2022. Regulatory certificates issued under the MDD after May 2017 will remain valid until they expire (to a maximum of five years), or through May 2024. Between May 2024 and May 2025 — the so-called “sell-off period” — manufacturers can continue to sell MDD-certified devices, but must ensure that none are on the market or in service once that period elapses.
Key Changes and Market Impact
The MDR has generally enlarged the scope of what constitutes a medical device, and is designed to produce harmonious results across member states by superseding national laws and previous directives; this comes to unify the legal framework surrounding medical devices across the EU.
Directives Vs. Regulations — One of the most important changes presented by the MDR is that its terms are binding to all member states at the moment of application, whereas the terms of the MDD were non-binding, creating variation as they were incorporated into the national laws of member states. Still, there remain opportunities for member states to monitor their national markets and ban certain high-risk devices.
- IMPACT: This change is expected to reduce inconsistency in implementation between countries, given that the regulations supersede the laws of individual member states. This will make it easier for companies to manage their portfolios across multiple countries. However, given that member states still have the power to ban devices and create special registration for high-risk devices, entry may be more challenging for such devices in certain countries.
Notified Bodies (NBs) — Under the MDR, NBs operate under stricter guidelines; while these entities previously operated as industry partners, they will now work as a police-like extension of conformity assessments. NBs will have to be reaccredited under the MDR and, once accredited, must conduct annual audits and assessments on manufacturers’ quality management and postmarket surveillance systems, as well as unannounced inspections. NBs will also have stricter requirements for highly qualified staff and will be obliged to request expert panels to scrutinize their clinical evaluation assessment reports for high-risk devices.
Due to the challenges presented by COVID-19 on the designation of NBs, such as the ability to conduct on-site assessments, the European Commission is allowing member states to designate NBs under the MDR without having to follow all designation procedures; this will likely enable member states to expand their capacity for regulatory submissions during the one-year MDR application delay. That said, these designations are temporary and expire after one year.
- IMPACT: The overall number of NBs is expected to decline because many currently accredited NBs may not be able to meet the new qualification requirements; additionally, the process of accreditation will likely be more challenging and time-consuming, possibly impeding NBs’ bandwidth for evaluating devices once the MDR comes into force. This will likely result in bottlenecks and commercialization delays, due both to operational delays within accredited NBs and to a general scarcity of accredited NBs, especially in the early days of the MDR. Nonetheless, the stricter NB guidelines will ultimately result in safer, more effective, and higher quality commercialized devices, which will support physician and patient confidence in the state of the European market.
The easing of requirements for NB designation during the COVID-19 pandemic, coupled with the MDR application delay, may enable the designation of a larger number of NBs than previously anticipated, which could ultimately mitigate expected bottlenecks and submission pressures.
Definitions and Classification — The definition of “Medical Devices” has been broadened under the new regulations to include implantable and invasive devices, software intended to be used for a medical purpose, products with medical attributes that are not intended for a medical purpose, and products made for cleaning, disinfecting, or sterilizing medical devices.
Furthermore, “Accessory Devices” are now a wider category, including any device “meant to assist or enable another device(s) in its intended medical purpose,” while “Single-Use device” is now defined as a device intended for use during a single procedure, as opposed to “a device intended to be used once only for a single patient.”
- IMPACT: This change is of paramount significance because it may alter the classification of a number of products and bring several other products under the scope of medical device regulations. Device manufacturers preparing for the onset of the MDR will pay close attention to this change’s specific outcomes, as it may substantially affect their product classification and, subsequently, their commercialization strategies — specifically, because classification changes may require the collection of more clinical evidence or reapplying for CE marking or NB assessment.
Stronger Regulatory Oversight — Whereas the MDD allowed manufacturers to choose between five paths to conformity assessments, the MDR includes only three paths. In addition, the criteria for demonstrating equivalence is now stricter, and requirements for technical documentation and clinical data have been strengthened. Furthermore, for clinical evaluations and investigations, the MDR promotes a shift from one-time/pre-approval approaches toward a “life-cycle” approach, which means manufacturers will have to establish strict postmarket surveillance plans, conduct postmarket performance follow-ups, produce periodic safety reports, and provide technical documentation with heightened requirements.
For high-risk devices in particular, fewer cases will be able to utilize equivalency evidence, and clinical trials for Class III devices will have to be approved by member states and an ethics committee before beginning; in addition, expert panels at the EU level will be required for the evaluation of Class III and some Class IIb devices.
- IMPACT: Manufacturers will be forced to spend more time and resources on quality control and device documentation, ensuring their current and developing devices abide by the MDR, which may make development and commercialization of some device types more expensive. Additionally, post-approval costs will rise because companies will have to conduct ongoing clinical assessments to evaluate long-term performance; plus, companies will likely find it difficult to find qualified compliance professionals, which may lead to commercialization delays.These challenges will be amplified for manufacturers of high-risk devices, which will require more resources for planning, clinical trials, and panel/committee approvals. However, these changes are likely to improve the quality of commercialized devices and lessen the probability of failure and adverse events, bolstering patient and physician perceptions of various medical devices.
Expanded Accountability Mechanisms — Notably, the MDR requires manufacturers outside the EU to appoint Authorized Representatives (ARs); these representatives provide Competent Authorities (CAs) with all required technical documentation and relevant certificates, as well as report incidents to NBs, CAs, and manufacturers. In essence, ARs are considered local representatives to foreign manufacturers, and are expected to share legal liability in the EU alongside the manufacturer. In addition, the MDR obligates manufacturers to obtain liability insurance to provide patient compensation in the event of device defects and adverse events. Further, third-party device reprocessing companies are now fully liable for the safety of the devices they reprocess.
- IMPACT: Heightened accountability under the MDR may incentivize ARs — who share liability — to terminate their mandates with manufacturers if there are quality or documentation concerns. This may limit device entry, but could improve the quality of imported devices that are successfully commercialized.While the number of third-party reprocessing companies may decline, limiting the availability of inexpensive reprocessed devices in some markets, greater regulation of reprocessed devices could drive confidence in the remaining products, supporting device affordability and overall uptake. Finally, because the MDR requires manufacturers to carry liability insurance, costs for manufacturers will rise.
Traceability and Transparency — One of the most significant changes under the MDR is the utilization of a Unique Device Identifier (UDI) system across the EU to enhance the effectiveness of postmarket safety-related activities, block the use of falsified and counterfeit devices, improve purchasing policies and stock management, and assist in the strengthening of electronic medical records. Under this policy, manufacturers of high-risk devices will need a UDI for those devices by the date of MDR application, while lower-risk devices will have up to four years from the date of application; in addition, manufacturers will be required to submit all device data to the UDI database.
Further, the MDR requires the use of the publicly accessible European Database on Medical Devices (EUDAMED) to integrate different electronic systems, collate and process information — specifically regarding devices, economic operators, conformity assessments, NBs, certification, clinical investigations, vigilance, and market surveillance — and allow for the submission of documentation (such as Summary of Safety and Clinical Performance) to be included in technical documentation for conformity assessments. In October 2019, EU officials announced that EUDAMED will become operational in May 2022, as opposed to the originally planned date of May 2020.
- IMPACT: The utilization of UDIs and EUDAMED that are publicly available and easily accessible will be critical to supporting physician and patient attitudes toward various medical devices across the EU, and will also improve general awareness of adverse events or complications, allowing patients and physicians to incorporate data and knowledge of postmarket events into their decision-making processes. Further, because the MDR requires the UDI database to avoid the inclusion of any “commercially confidential product information,” its application may lead to an increase in patent filings in the EU.Moreover, while the EUDAMED delay provides manufacturers with a brief respite from having to upload information to the online portal — such as registration documentation, vigilance reports, and periodic safety update reports — it does not exempt them from having to prepare all necessary documentation in accordance with EUDAMED guidelines. Until EUDAMED becomes fully operational in 2022, manufacturers are expected to follow the reporting guidelines outlined in the MDD.
Overall: Safer Devices and Improved Transparency, Higher Costs and Commercialization Delays
Ultimately, it appears that, while the new regulation will result in increased costs, commercialization delays, and device removals for manufacturers, it will eventually lead to heightened device safety and effectiveness and will support transparency throughout the European medical device market — fulfilling its intended purpose.
That said, the MDR poses serious challenges for current and prospective market players throughout Europe, many of whom have made it clear they feel unprepared. For instance, many companies, especially smaller ones, will likely be pushed out of the market because they will not be able to comply with the MDR by the date of application, due to lack of resources, time constraints, or both. In addition, many companies will likely have to make difficult strategic decisions to prioritize certain products — particularly those certain to generate sufficient sales to cover the costs of compliance — over others.
On a more global scale, the MDR may render Europe a less attractive point of entry into the global medical device market; under the MDD, Europe was viewed as a strong starting point for medical devices because entry was seen as less arduous and costly than in the US. Under the MDR, though, this trend may be reversed.
Timely Implementation Concerns
Prior to the enactment of a one-year MDR DoA delay, it had been unclear whether European authorities would be ready to implement the MDR by its original DoA; for instance, as of May 22, 2020, only 14 NBs had been designated under the MDR, compared to 49 designated under the MDD. Most of these NBs are now managing a workload that includes both MDR applications and applications to recertify MDD devices prior to May 2021, in addition to submissions related to COVID-19.
In addition, there had been considerable concern across Europe regarding the ability of companies to abide by the MDR by its initial DoA. This is particularly relevant in the case of some devices considered Class I under the MDD, but set to be up-classified under the MDR, which would require the involvement of a NB for the first time. In fact, in a corrigendum issued in November 2019 and adopted in December, the European Commission amended Article 120 of the MDR to address this issue, providing manufacturers of such devices a transitional period that will allow the companies to continue manufacturing and selling those products while they pursue MDR compliance by May 2024.
This grace period also alleviates pressure faced by NBs to process the sheer volume of applications relating to relatively low-risk products — including reusable surgical instruments (e.g., scalpels and forceps), sterile and measuring devices, and software — currently classified as Class I (but set to be up-classified under the MDR).
MDR concerns had also touched industry players in the U.S.; in July 2019, the U.S. sent a letter to the WTO’s Committee on Technical Barriers to Trade voicing reservations surrounding the timely implementation of the MDR and urging the EU to consider a delay of three years, but the EC repeatedly stated its opposition to any delays prior to the COVID-19 pandemic.
Now that the date of application has been pushed to May 2021, relevant parties — including manufacturers, regulators, and member states — will be able to better focus their resources on the COVID-19 response. In addition, the delayed DoA, coupled with temporary easing of requirements for NB designation, may allow for the designation of a larger number of NBs by the DoA, which would mitigate the impact of previously anticipated regulatory bottlenecks that could affect approval timelines.
However, given the unprecedented nature of the current challenges facing the medical device industry, it is unclear when the impact of the COVID-19 pandemic on medical device stakeholders will subside sufficiently to enable regular operations. It is also unclear whether stakeholders will be in a stronger position to effectively implement the MDR by May 2021. Therefore, considering the ongoing uncertainty regarding timely and effective implementation, the extent of the MDR’s impact on European — and, by extension, global — medical device markets remains difficult to predict.
What is already clear is that all European industry players — manufacturers, NBs, representatives, or otherwise — must invest in preparing for the application of the new regulations, or risk irrelevance and considerable financial and competitive losses.
Next Steps for Manufacturers
- Monitor the ongoing release of guidance documents and legislative changes relevant to the MDR.
- Conduct portfolio assessment to determine how your products will be classified under the MDR; consider whether divestment or prioritization of certain products will be necessary; ensure legacy products are recertified by the application deadline.
- Update processes and procedures to meet MDR requirements — these activities include establishing or updating your compliance plan and quality-management systems, particularly for postmarket surveillance and postmarket clinical follow-ups.
- Review all of your product documentation to eliminate any gaps in clinical data and technical documentation record-keeping.
- Secure a suitable Notified Body; share your compliance plan.
- Following product launch, ensure availability and accuracy of all required postmarket systems and documentations.