By Zaid Al Nassir, Decision Resources Group (DRG)
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 implementation beginning in May 2020. These regulations were introduced to address 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, and discusses the anticipated impact on medical device markets.
The MDD’s Shortcomings
Adopted in the early 1990s, the MDD comprises three directives: the Supplementary Directive for In Vitro Devices, the Supplementary Directive for Implantable Devices, and the Primary Medical Device Directive. Although the MDD played a significant role in the European medical device market’s success over the past three decades, the Directives’ weaknesses have rendered them somewhat ineffective in the contemporaneous 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- Outdated regulations: The MDD did not keep up with technological developments (and the regulatory challenges they incur) in the medical device space, particularly those related 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 OEM, overlooking 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 (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, that the MDD represented a suitable legislative and legal basis for regulating medical devices, but 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 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.
The MDR is expected to become applicable in May 2020. It is important to note that regulatory certificates issued under the MDD before May 2017 will remain valid until they expire, or up to 2 years following the date of application (2022, presumably), whereas those issued under the MDD after May 2017 will remain valid until they expire (to a maximum of 5 years), or up to 4 years following date of application (May 2024).
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: While the MDD was non-binding, giving EU member states leeway in determining how to implement it, the MDR is binding and applies to all member states at the moment of implementation. That said, there is still room 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: 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 must 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 perform unannounced inspections. NBs will also have stricter staff qualification requirements and will be obliged to request expert panels to scrutinize their clinical evaluation assessment reports for high-risk devices.
- 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 European market.
- Definitions and Classification: The definition of “medical devices” has broadened under the MDR 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. Further, “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, versus “a device intended to be used once only for a single patient.”
- Impact: This change is significant because it may alter the classification of a number of products, and bring as-yet-unregulated products under the MDR’s umbrella. Device manufacturers will pay close attention to this change’s specific outcomes, as it may 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.
For example, spinal disc replacement implants and other devices that come into contact with the spinal column will be up-classified to Class III, while devices that penetrate the body through mucus membranes will be considered “surgically invasive devices” under the MDR; moreover, high-risk devices will now require the involvement of a pool of experts at the EU level to perform premarket evaluations.
- Stronger Regulatory Oversight: 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. Further, for clinical evaluations and investigations, the MDR promotes a shift from one-time/preapproval approaches toward a “life-cycle” approach, meaning 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: It is crucial to note that the MDR does not allow currently commercialized devices to maintain their status once the regulations are applicable; therefore, all manufacturers will be forced to spend more time and resources on quality control and device documentation, as well as make sure their current and in-development devices abide by the MDR — potentially driving up development and commercialization costs.
Post-approval costs also will rise because companies will have to conduct clinical assessments to evaluate long-term performance on an ongoing basis; additionally, 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, compliance is 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, and 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 these devices could drive confidence in the remaining products, supporting device affordability and overall uptake. Finally, because the MDR requires manufacturers to carry liability insurance, associated costs will rise.
- Traceability: 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 all other devices will have up to five years from the date of application; in addition, manufacturers will be required to submit all device data to the UDI database.
- Transparency: 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 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.
Overall: Safer Devices and Improved Transparency, Higher Costs and Commercialization Delays
Setting aside the MDR’s numerous details, it appears that, while the new regulation will result in increased costs, commercialization delays, and device removals for manufacturers, it ultimately will 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 clear that 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 either to lack of resources or time constraints. 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.
Implementation Date: Firm or Flexible?
It remains unclear whether European authorities will be ready to implement the MDR by the date of application; for instance, as of October 2019, only five NBs had received accreditation (and fewer than 20 are expected to be accredited by the end of 2019), and many of those have already reported immense workloads from clients seeking assistance with MDR compliance.
In addition, there is considerable concern across Europe regarding the ability of companies to abide by the MDR by the date of application. The European Commission has considered amending the MDR to provide Class I devices with a four-year transitional period (as of May 2020) to ensure compliance, but it is unclear whether such a delay will actually be implemented.
MDR concerns also have touched the U.S.; in July 2019, the U.S. sent a letter to the WTO’s Committee on Technical Barriers to Trade, voicing concerns surrounding the implementation of the MDR and urging the EU to consider a delay of three years.
Given the uncertainty surrounding MDR implementation and all stakeholders’ ability to adequately prepare by May 2020, the extent of the MDR’s impact on European — and, by extension, global — medical device markets remains uncertain. What is already clear is that all European industry players — manufacturers, NBs, representatives, or otherwise — must invest substantially in preparing for the application of the new regulations, or risk irrelevance and considerable financial and competitive losses.
About the Author
Zaid Al-Nassir is a senior product support analyst at Decision Resources Group. He holds a B.A. in Political Science, History, and Writing & Rhetoric from the University of Toronto. Zaid can be contacted at firstname.lastname@example.org and through LinkedIn.