“In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745 by one year.”
— European Commission
Extended Deadline for EU MDR Implementation Quickly Approaching
When the pandemic hit the world in March 2020, several medical device manufacturers went into rapid production and distribution of diagnostinfluc tests, personal protective equipment (PPE), ventilators, and more. To this day, the sustained increase in demand has translated into less available resources to continue medical device regulation (MDR) and in vitro diagnostic regulation (IVDR) preparation and readiness processes. “Shelter-in-place” policies complicated matters even further. As governments around the world began to implement various social distancing mandates, industries followed suit with work-from-home policies, ultimately leading to an even shorter supply of notifying bodies (NBs) available for onsite inspection.
In response to this unprecedented global public health crisis, and in an effort to not disrupt hospital supply chain continuity, the European Commission’s proposal to delay EU/MDR implementation until May 26, 2021 became official on April 23, 2020. However, despite industry efforts, the hard deadline of May 25, 2022 for IVDR implementation has remained unchanged.
But the extended deadline is now quickly approaching once again. And, as the medical device industry readies itself for May 21st, manufacturers, authorized representatives (ARs), notified bodies (NBs), importers, and distributors must now overcome even more complex challenges before devices hit the EU marketplace — the second largest medical device industry in the world.
The Impact of Real-time Industry Demands on Compliance Readiness
As a precaution, in March 2020, the United States Centers for Disease Control and Prevention (CDC) published recommendations for healthcare facilities to postpone (or cancel) elective, non-essential medical, surgical, and dental procedures, and for hospitals to postpone (or cancel) elective surgeries. As a result, “more than 4 million surgeries [were likely] canceled over the peak 12 weeks of the pandemic (roughly mid-March to mid-June) in the United States, part of the 28.4 million (likely) cancellations worldwide,” according to MDDI Online’s Prasad Dindigal in mddionline.com.
According to the British Journal of Surgery, “each additional week of disruption to hospital services will be associated with a further 2.4 million cancellations.” In fact, “procedure comebacks are not expected until the second half of 2021.” But by then, the industry could see another resurgence — this time, a sharp increase in the number of patients flocking to reschedule their previously delayed medical procedures.
Pre-pandemic, time and resources devoted to MDR and IVDR compliance were already a challenge. If and when the resurgence of delayed procedures becomes the new reality, the medical device industry will once again find itself quickly switching from rapid production and distribution of COVID-19 products to the manufacture and distribution of copious amounts of elective medical and surgical devices. How will manufacturers meet EU MDR and IVDR compliance deadlines if, once again, they are faced with an unprecedented spike in demand for elective medical devices?
Accelerated Production of Medical Device Software
“[T]he need to create safe physical distances between healthcare workers and COVID-19 patients prompted medtechs to modify how their devices are used, including remote programming and monitoring.”
Data Source: Medical Device and Diagnostic Industry.
Rapid Growth in Digitized Software
From artificial intelligence (AI) to remote surgical systems, medical device manufacturers are stepping up their game to fight the pandemic. In fact, according to MedTech Dive, executives believe remote medical device technology, in particular, will likely become permanent offerings since the benefits extend well beyond the pandemic.
Robert Ford, chief executive officer (CEO) of Abbott Laboratories claims that remote care and digital health technologies allow for much more proactive management. Ford believes this advanced technology can decrease response time, cut down on logistical issues, and decrease challenges associated with in-person visits, ultimately leading to lower healthcare costs. According to McKinsey & Company, “responses to COVID-19 have sped the adoption of digital technologies by several years — many of these changes could be here for the long haul.
Increased Adoption of Telehealth and MedTech Services
Without question, the world has seen an increased adoption of telehealth services since the onset of the coronavirus. In fact, a growing number of patients from diverse age groups and demographics now rely on telehealth services when in-person is not available or recommended. Even health insurers that lacked consistency in payor coverage for telehealth services as well as providers who were once skeptical are getting on board.
In the United States, the Centers for Medicare and Medicaid Services (CMS) have temporarily approved more than 80 new telehealth services. Since the onset of the pandemic, 64% of the nation’s providers are more comfortable using telehealth and 76% of consumers are now interested in using this technology in the future (up from just 11% in 2019). Among the EU4 countries and the UK, all but Germany* saw a significant increase in the use of virtual consultation in 2020. In fact, UK-based Lexology (a web-based service providing the legal industry with practical intelligence) expects telehealth in Europe to remain, becoming even more widespread over time.
Even outside of the coronavirus demand, medical device manufacturers have upped their game in recent years with the production and distribution of wearables, telemedicine carts, kits, and software, digital cameras, mobile medical devices, and more. With increased consumer adoption, enhanced patient-provider reach, a reduced cost structure, and 24/7 coverage, investing in advanced medtech seems like an obvious decision. But there are a lot of legal barriers that manufacturers need to overcome, among them, liability risks, cybersecurity, and patient safety. In fact, when it comes to the new regulations, not only is patient safety of paramount importance, but some software will now be placed into higher risk classes according to Rule 11.
Data Source: Decision Resources Group.
EU MDR and IVDR Regulations Complicate Readiness
Rule 11 (MDR)
As the Johner Institute puts it, although not all software will be up-classified to Class two or three, for those that are, “manufacturers must involve notified bodies in general, establish a certified quality management system”
So, while the industry sees a growing appetite for these advanced technologies, adherence to Rule 11 further complicates compliance readiness efforts.
Barrage of New Documentation
1. Inordinate Number of Guidance Documents
The new MDR and IVDR regulations are already complicated enough to navigate, but with the ongoing publication of what could arguably be called an inordinate number of guidance documents, navigation becomes that much more complex. Between October 2017 and December 2020 for instance, the Notified Body Operations Group (NBOG), the Competent Authorities for Medical Devices (CAMD), the Medical Device Coordination Group (MDCG), the European Committee for Standardization (CEN), and the EU Commission published more than 60 documents collectively, all with the intention of supporting implementation. The EU Commission alone published nine new guidance documents in November 2018, followed by an additional five in the span of just a few days in early August 2019. 2020 saw a minimum of two dozen publications and updates.
With much of the content open to interpretation, some find this flurry of documentation helpful while others find it confusing, even contradictory. And when countries worldwide became locked down throughout 2020 due to the pandemic, frustrations heightened. Many manufacturers lost connection with their NBs and other key players, and with hospitals scrambling to care for COVID-19 patients, clinical trials were placed on hold. Nonetheless, the EU Commission’s expectations remain that manufacturers will meet the quickly approaching deadlines.
2. Expanded Regulations and Reclassifications
The new MDR regulations are not only four times longer than the EU Medical Devices Directive (MDD), but they contain five more annexes. With a clear focus on patient safety, these new regulations will undoubtedly “require most medical device manufacturers to update their clinical data, technical documentation, and labelling.” In fact, Class III devices alone will likely require three (or more) times the number of device labels and IFUs, according to Pharmiweb. And when we factor in Class II as well as reclassified Class I devices, as PharmiWeb puts it, “the second and third waves of EU MDR start to look alarming.”
In other words, somehow, amid the noise and haste, the industry still needs to find a way to keep abreast of the ever-changing regulations in order to mitigate risks and comply with the new regulations so that devices legally enter the EU marketplace in time.
Language Requirements Remain a High Priority
It has long been established that language barriers increase risk to patient safety and quality of care. In fact, for culturally and linguistically diverse populations, communication barriers increase the risk of patient dissatisfaction and poor health outcomes. If communication is not made a priority, widening disparities in healthcare access and quality of care will likely follow. It is unsurprising then, that the new MDR and IVDR regulations have expanded their patient safety requirements.
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
— death or an irreversible deterioration of a person’s state of health, in which case it is in Class III;
— a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
Source: Official Journal of the European Union
Who is Responsible?
With good reason, the new EU MDR and IVDR regulations have tightened language requirements in order to increase product efficacy and performance transparency as well as strengthen patient safety. While the regulations affecting language requirements impact all parties within the supply chain, including manufacturers, notified bodies, importers, and distributors, both manufacturers and distributors share the obligation to fulfill the language requirements:
- Article 10 (11), “Manufacturers shall ensure that the device is accompanied by the information … in an official Union language(s) determined by the Member State in which the device is made available.”
- Article 14 (2b), “Before making a device available on the market, distributors shall verify that all of the following requirements are met [including that] the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10 (11).”
Ultimately however, responsibility surrounding language requirements lies with the manufacturer. Since it is the manufacturers (or importers) who place the device on the market, they must ensure the device is MDR and IVDR compliant. Bear in mind, however, that required documentation does not necessarily need to be translated in all 24 of the EU’s official languages. Manufacturers must determine in which Member State(s) they intend to distribute their device(s), which will then dictate the specific languages in which the content needs to be made available.
Types of Content Requiring Translation
As McKinsey & Company state,“Content intended for users or patients must be provided in any of the EU’s 24 official languages [or any combination thereof] where products are distributed. [This adds significant complexity for manufacturers when managing multiple documents, in multiple languages across the supply chain.” McKinsey & Company
The EU MDR and IVDR regulations are the most significant changes the industry has seen in decades. This is particularly true with regard to the volume of documentation, the inordinate amount — and heightened frequency — of published guidelines, the increased regulatory scrutiny, and the translation requirements involved. In fact, even some products with non-medical purposes will now be affected. When we consider instructions for use alone, Pharmiweb states that a “mid-sized device manufacturer may have [anywhere] from 100 to over 1,000 IFUs across their product line. Rewriting these content-heavy documents in a style appropriate for the user, adding new symbology and statements, plus translating into languages for 20+ EU countries makes the task of updating these to comply with EU MDR larger than first anticipated.”
On the right, we have broken down the types of translated documentation that the EU MDR and IVDR regulations require. However, this is only a general view. It is also important to recognize that, with so many frequent updates from the European Commission, this article is considered a live document. As such, it is advised that you continue to do your due diligence to keep abreast of any further developments.