Earlier this year, a new regulation governing medical devices in the European Union went into effect. The European Union Medical Device Regulation (MDR) was created in May 2017 and became finally applicable on May 26, 2021, after a 1-year extension necessitated by the global COVID pandemic. Several transitional provisions will remain in place until 2025 to further help to avoid market disruption.
According to the , “Medical devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.” There are more than 500,000 types of medical devices on the market today including contact lenses, x-ray machines, ventilators, pacemakers, software, breast implants, hip replacements and band-aids, to name a few.
Impact on North American Manufacturers
The European Union’s medical device market is the second largest in the world, behind only the United States. The U.S. International Trade Commission (USITC) in its stated:
U.S. medical device manufacturers are the biggest suppliers of the EU’s medical device market, accounting for close to two-thirds of their imports in recent years and 41 percent of medical device patent filings with the European Patent Office. The new regulatory structure created by the MDR will likely create a number of challenges for U.S. medical device manufacturers, including additional compliance costs, regulatory uncertainty, and the classification of new products as medical devices.
Of particular note is the possible delays to market approval, which may arise due to the time needed to comply with revisions to the EU’s conformity assessment procedures (e.g. new clinical trial procedures, and labelling and registration requirements). At the same time, delays would likely result from the shortage of Notified Bodies available to approve medical devices for the EU market.”
Goals and Scope
The EU MDR, comprising 123 Articles and 17 Annexes, covers a broad range of medical devices, from contact lenses and band-aids to software, pacemakers and hip replacements. The regulation’s goals include that “it increases transparency and brings EU legislation in line with technological advances and progress in medical science. It improves clinical safety and creates fair market access for manufacturers.” It intends to provide better definition of the medical devices and to improve transparency through data standardization, technological advances and the establishment of the European database on medical devices (EUDAMED). Similar to the United States FDA’s Unique Device Identification System (UDI System), EU MDR strives to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.”
Describing the regulation, Stella Kyriakides, European Commissioner for Health and Food Safety, said: “This is an important step forward for the protection of patients across Europe. The new rules improve the safety and quality of medical devices while providing more transparency for patients and less administrative burden for businesses. The legislation will strengthen innovation and our international competitiveness, ensuring that we are ready for any new and emerging challenges.”
What is Included?
The MDR covers all medical devices sold within the EU, from needles to prosthetic limbs and ventilators. These devices were previously governed by two separate European directives: the Medical Devices Directive (MDD, 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC).
In vitro devices will be covered by the new In Vitro Diagnostic Medical Devices Regulation (2017/746/EU), which is a complement to MDR and will go into effect on 26 May 2022. In vitro diagnostic medical devices are used to perform tests on patient samples. They include such diagnostics as blood sugar monitoring systems for diabetes, pregnancy and COVID-19 tests, as well as HIV blood tests.
The MDR is wide reaching as it covers almost the entire lifecycle of a medical device and therefore has the potential to have an impact on an array of additional company divisions, products, processes and stakeholders. It requires more evidence and proof demonstrating the risk/benefit analysis, specifically the clinical evaluation before and after the product market introduction.
The regulation is also substantially increasing the prerequisites required to obtain the CE marking as well as the requirements for transparency and traceability. The MDR additionally outlines requirements regarding the design and manufacture of medical devices.
What to Remember? Patient Safety first ….
As described, this new regulation has a huge impact for medical device companies and the way they develop innovative solutions. But one important thing to note is how much this is changing the philosophy of medical device lifecycle management – which will now be centered on the value it is supposed to deliver for the patient. This is well aligned with the global trend towards improving the patient experience with value-based design and outcomes-based medicine. Driven by the fact that this new regulation is centered on the clinical benefits such medical devices bring and of course, patient safety.
Two examples to note:
1) The new EU MDR is adopting a more universally risk-based approach when compared to the EU MDD (93/42/EEC), involving more explicit requirements for manufacturers regarding the maintenance of a risk management program and life-cycle risk management. The EU MDR defines risk as “the combination of the probability of occurrence of harm and the severity of that harm” and, benefit-risk determination is defined as “the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer.”
2) The EU MDR requires more clinical investigations (or clinical trials) involving investigational devices. The articles mention topics related to clinical investigations including; the need for informed consent, considerations for vulnerable populations, the application process, requirements for the conduct of the investigation and Adverse Event reporting. While the regulation is new in Europe, it brings into line the requirements for clinical trials involving investigational devices in many other places of the world.
Does the MDR Apply to You?
Given the complexity and wide-ranging effects of the regulation, some companies are rethinking their EU product portfolios. Because the EU MDR changes the definition of “medical device”, it is most important for companies to first understand if and how the regulation applies to them.
The MDR defines “medical device” as “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended to be used” for a variety of specific medical purposes outlined in the regulation.
Of particular significance is software, which is mentioned in the regulation 48 times, including requirements for software verification and validation: “describing the software design and development process and evidence of the validation of the software, as used in the finished device.” The regulation calls for inclusion of “results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release.” Notably, simulation will play an increased role in verification, validation and testing of medical devices.
Recognizing the complexity of the new regulations and the great importance of medical devices, the European Commission prepared detailed information for the various stakeholders involved. For example, dedicated factsheets, infographics and step-by-step guides provide actionable information and points of consideration, some available in multiple languages.
Some of the stated goals of the EU MDR are to “reflect the substantial technological and scientific progress in this sector over the last 20 years” and “to improve the safety of medical devices, with a view to modernise the sector and to consolidate the EU’s role as a global leader in this area.” It is the view of the European Commission that the new regulation “paves the way for a more patient-friendly environment, where transparency and patients’ information and choice are a priority, and where patients can benefit from innovative, high-performing devices and new therapies.”
While some of the new requirements brought on by the regulation may be disruptive and bring challenges, the MDR also provides an important opportunity for the industry. With the multitude of technological and scientific advances in the last two decades, the power of digital transformation and data can be more fully utilized by the entire life cycle of medical device design and manufacture. Catalyzed by the new regulation, there will be increased implementation of available innovations such as integrative platforms for collaboration, tracking and traceability, compliance, data exchange, modeling, simulation and testing. In addition, the sector will continue to innovate, developing new solutions to address the specific challenges that arise as a result of the MDR.
Some companies may need to upskill their employees and/or work with a network of consultants or subcontractors, with responsibility for regulation compliance. In fact, adherence to the MDR will become another competitive advantage in the EU market, while greatly benefiting patients and everyday users of the many products now classified and regulated under the “medical devices”, “accessories” and “aesthetic products” categories. Those companies who are already focused on utmost safety and total quality will thrive, and products will become better when everyone’s focus will be on improving safety and quality.
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