Do you wish to market your product in the EU? Well, things just got more complicated. Under the new EU MDR, CE- Marked devices must now meet much more extensive requirements regarding the availability, collection, and evaluation of Post Market clinical data. Due to these increased requirements, manufacturers and auditors have noticed a large increase in the amount of clinical data required to meet the new EU MDR requirements. Device manufacturers must also implement a proper Post Market Clinical Follow-Up (PMCF) plan.

The PMCF, a part of the Post- Market Surveillance (PMS) system, is greatly emphasized under the EU MDR as a crucial strategy for data collection and evaluation to ensure device compliance. The PMCF consists of two parts: the plan, where activities are documented and justified; and the report, where results are presented. Before the MDR, PMCF plans were considered passive, requiring only simple actions such as complaint monitoring and literature searches. Now, with the emphasis on PMCF as a continuous process, PMCF plans must be proactive, expanding to include processes such as PMCF studies, user surveys, and data collection from registries.  The MDR requires that every medical device considers the need for a PMCF. If it is determined to be not needed, the reasoning and proof of gap assessment must be documented in the Technical Documentation.

What does this mean for you?

1. Be proactive. Use this time to conduct a gap assessment and formulate a thorough, organized, and comprehensive PMCF plan before meeting with a notified body. This will allow the process to go smoothly, increasing chances of a fast CE- Mark certification approval and getting your product on market sooner.
2. Use your resources. To maximize PMCF efficiency, you must first truly understand its requirements and how they relate to you. These new requirements create confusion for medical device manufacturers globally- what is “sufficient” clinical evidence? What activities should be conducted to save time and ensure accurate data? Do I have a gap in my data on my own device? The answers may vary. Our team has experience in all relevant fields; from gap analysis to CE- Mark certification to PMCF research and clinical data analysis. Let us formulate the perfect PMCF plan for you and get your device on the market ASAP.

Confused as what your next steps should be? Let us figure it out. Fang Consulting can help you ensure EU MDR compliance with your medical device. We will work directly with your company to find the quickest path to success with the most efficient and cost- friendly methods. Please contact us at info@FangConsulting.com for a free consultation today.

On July 6^th, 2022, the European Commission released an updated version of the EUDAMED timeline. This version delays important milestones by exactly 1 year, meaning the “full functionality” of EUDAMED is delayed as well. Though the European Commission has stated in the past that EUDAMED is voluntary, Importers can require companies to submit their data in order to continue selling through them. Additionally, after posted transition periods, once “full functionality” is achieved it will be mandatory to submit devices to EUDAMED prior to selling within the European Union.

What does this mean for you?

1. Do not procrastinate. While this extra time might seem like a reason to celebrate, it is not advisable to delay submitting your data to EUDAMED. Given extra time for the industry to prepare for these transitions, it is crucial to not make the mistake of putting off your data preparation and submission.
2. Use the delay to your advantage. The process of gathering and collecting data to meet the standard is longer than one may think. It is important to maintain your momentum and continue to gather proper data, as well as set up a product ID standard.

 

Confusing? We can help you figure it out. Fang Consulting can help your company figure out the complex regulations and data requirements that come with the EUDAMED updates. Contact us at info@fangconsulting.com for a free consultation.

As of June 7, 2022, the Food and Drug Administration (FDA) has announced their intent in the Federal Register to withdraw the guidance document entitled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices- Questions and Answers (Revised).” Originally issued in June 2020 and updated in December 2020, this document was issued in response to the COVID-19 pandemic to provide answers to commonly asked questions about regulatory issues related to device development during the declared state public health emergency.  Among many other documents, this guidance was implemented immediately under the authority of the Emergency Use Authorization (EUA) and intended to only remain in effect until the COVID-19 crisis returned to pre- pandemic levels.

While we knew this would happen at some point, the announced document withdrawal date of July 7, 2022, makes it apparent that the EUA will end next month. What does this mean for the medical device industry? The EUA expedited approval for many devices during the pandemic, meaning that once the EUA ends, devices authorized under the EUA may no longer be legally marketed unless it receives marketing authorization from the FDA. This had become a glaring issue for many in the medical device industry. Fortunately, there is a solution- manufacturers are encouraged to pursue submissions through the appropriate regulatory pathway before the EUA ends to ensure their devices can remain on marker post pandemic.

Questions?  

Contact us at info@fangconsulting.com for more information or to schedule a free consultation for your regulatory needs.

Imagine that you’ve discovered a problem with a medical device – maybe something that makes the device downright dangerous, or maybe something that just makes it less effective than it should be. What should happen next? You’d probably want some way to halt the use or shipment of the same or similar devices… or devices made at the same factory… or devices made with the same material, or with material from the same batch… or that had passed through the same sterilizer… and so on. And, in addition to stopping use or shipment, wouldn’t you want to be able to investigate the cause of the problem – the better to correct it, and prevent its recurrence? That would require tracing it all the way back to some specific issue (or combination of issues) involving the device’s storage… or maybe its handling… sterilization… or possibly its manufacturing… perhaps even its design. To do any of this would take information, potentially involving a long chain of entities reaching back through distributors – and, for foreign-made devices, through an importer – back to the device’s maker and designer.

The European Union’s new Medical Device Regulation (“MDR”) anticipates such a situation. It identifies four specific links in that chain of entities, designating them as “economic operators,” and assigning them specific duties – collectively and individually – to make medical devices (and problems with them) traceable in the EU.

So, are you an economic operator? Just what – or who – counts as an economic operator?

Economic Operators

Article 2(35) of MDR spells it out: An economic operator is

• a manufacturer,
• an authorized representative,
• an importer,
• a distributor, or
• an individual or company that puts together and/or sterilizes systems or procedure packs.

Some of these terms require a bit of explanation.

You’re a manufacturer if you manufacture a medical device, of course – but also if you refurbish a device, or if you market a device under your name or trademark after you’ve had someone else design, manufacture, or fully refurbish it. (See MDR Article 2(30).)

You’re a distributor, according to Article 2(34), if you’re “any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service” – an expansive definition that means any given device in Europe may have many distributors.

The MDR definitions of authorized representative (Article 2(32)) and importer (Article 2(33)) are more straightforward: An authorized representative is “any natural or legal person established within the [European] Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under [the MDR]”; an importer is “any natural or legal person established within the Union that places a device from a third country on the Union market.”

And for that final category – assemblers and/or sterilizers of systems or procedure packs – MDR defines a system as “a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose” (Article 2(11)), while a procedure pack is “a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose” (Article 2(10)).

Responsibilities

Major responsibilities of economic operators include:

1. submitting, collecting, and maintaining various information;
2. facilitating inspections and investigations by national regulatory agencies; and
3. carrying out corrective actions for dangerous or noncompliant devices.

Let’s look at each of these in turn.

1. Submitting, Collecting, and Maintaining Information

The MDR has been in effect since 26 May 2021 – but its full implementation relies upon the existence of a great database whose completion has been repeatedly delayed. We’re talking about EUDAMED, the European database on medical devices; it, and the means of complying with MDR until it is complete, are topics for another post. Note carefully: Our discussion here is about MDR as written, assuming a fully-operational EUDAMED. Before trying to understand the current, interim state, we have to understand the planned end state.

Many economic operator responsibilities fall on manufacturers, authorized representatives, and importers, who must submit information specified in MDR Annex VI to register themselves, as well as every device they intend to put on the market in the EU; see Article 31(1). Annex VI spells out additional responsibilities to manufacturers to enter a Unique Device Identifier (UDI) code and a range of other information about each device – mostly the same kinds of information captured in the device’s labeling (for example: manufacturing date or expiry date; storage and/or handling conditions; whether or not the device is single use, is labeled sterile, contains latex; etc.). If any of this information changes, the relevant economic operator must update the data in EUDAMED within one week (Article 31(4)). Additionally, within a year of the initial submission of data to EUDAMED, and every other year thereafter, the relevant economic operator must confirm the accuracy of the data (Article 31(5)). Any economic operator that fails to provide this confirmation within six months of the deadlines risks the possibility that any EU Member State “may take appropriate corrective measures within its territory” until the economic operator complies (Article 31(5)).

To aid the traceability of products along the supply chain, economic operators must be able – for at least fifteen years after the last placement of any given implantable device on the market, or at least ten years for non-implantables – to identify the following to any EU member state’s competent authority:

1. “any economic operator to whom they have directly supplied a device;
2. “any economic operator who has directly supplied them with a device;
3. “any health institution or healthcare professional to which they have directly supplied a device” (Article 25).

Additionally, economic operators must “store and keep” the UDI of any class III implantable devices, or of any other devices, categories or groups of devices designated by the European Commission (the EU’s executive arm), which those economic operators have supplied or with which they have been supplied.

MDR also specifies that responsibility for post-market surveillance rests on “manufacturers in cooperation with other economic operators” (Article 2(60); emphasis added). Economic operators must work together to create and maintain “a systematic procedure to proactively collect and review experience [from the devices they help supply] for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions” (Article 2(60)).

Redundant efforts among economic operators are likely – and, in any case, communication and coordination are essential. Assuming that someone else in the supply chain is keeping track of data, or submitting it to EUDAMED, or updating it when it changes, could be a big mistake.

2. Facilitating Inspections and Investigations

Individual EU Member States have their own respective national regulatory agencies, which EU MDR refers to as “competent authorities.” Economic operators and competent authorities deal with each other in the contexts of inspections and investigations.

First, inspections: Article 93 provides for competent authorities to inspect the documents and the premises of economic operators; the economic cooperators must cooperate (Article 93(3)(a), (b)). A competent authority that inspects an economic operator’s premises must communicate its findings, including any needed corrective actions, to the economic operator, which may submit comments. After receiving any comments, the competent authority then finalizes the inspection report and enters it in a market-surveillance module of EUDAMED (Article 93(7)).

As with inspection, so with investigation: Economic operators must also “cooperate with the competent authorities” of a Member State when those authorities have reason to believe that a device may present an unacceptable risk, or that it otherwise does not comply with MDR. In such cases, the competent authorities “shall carry out an evaluation of the device concerned” covering all MDR requirements relating to the risk, or to any other non-compliance of the device (Article 94(b)).

3. Corrective Actions

A competent authority’s investigation of a device may have a positive outcome (finding nothing wrong), or a negative outcome – either more negative (finding an unacceptable risk to health or safety), or less negative (finding noncompliance with EU MDR, but no unacceptable public health risk).

In the more negative case – where the competent authority finds the device unacceptably risky – Article 95 requires the competent authority “without delay” to “require the manufacturer […], its authorised representative […] and all other relevant economic operators” to restrict, withdraw, or recall the device, as applicable, within a time period communicated by the competent authority.

In the less negative case – where the competent authority finds noncompliance without an unacceptable risk – Article 97 provides for the competent authority to “require the relevant economic operator to bring the non-compliance concerned to an end” – again, within a time period communicated by the competent authority.

Your Link in the Chain

Problems with medical devices can be effectively isolated and investigated only to the extent that the devices are traceable. MDR’s authors have attempted to build traceability into the regulations of the European Union by defining and assigning a wide range of responsibilities to a similarly wide range of entities throughout the medical-device supply chain: the economic operators. The expansiveness of the “manufacturer” and “distributor” categories in particular brings many businesses within the scope of this regulation – a regulation that is still new. As the implementation and interpretation of MDR evolve, Fang Consulting can help you fulfill your responsibilities to keep safe, effective, traceable products on the market in Europe, whatever your link in the supply chain.

Milk or dark chocolate? Paper or plastic? Mountains or the beach? EUA or 510(k)?The Emergency Use Authorization question may not be as polarizing as the others, but it has been dogging medical device and pharmaceutical companies for well over a year. The answer may seem obvious – choose the more streamlined EUA path and get your product to market quickly – but as the pandemic raged on and the EUA requirements changed, it became less clear.

In the early days of the pandemic, the EUA certainly seemed the smarter move as the need for PPE, ventilators, test kits, therapeutics and vaccines skyrocketed. But some manufacturers still opted to go the full 510(k) route, slow and torturous as it may be, even if it meant missing out on piles and piles of pandemic-induced revenue. Were they being old-school and obstinate – or strategic?

The EUA is Dead! Long Live the EUA!

Throughout the past year, the EUA has been both heralded and demonized, depending on which product or need was first up on the nightly news. When the vaccines were made available after just ten months, pundits and pontificators alike cheered the FDA for approving the inoculant so quickly. But when those rapidly approved COVID test kits started producing too many false negative or false positive results, the talking heads were quick to berate the FDA for inadequate oversight. Not exactly the type of publicity the FDA was hoping it would get.

Public opinion notwithstanding, the EUA really was established with the best of intentions. The emergency use authorization process was formally established in 2004 after the anthrax-in-the-mail incidents that followed the attacks on the World Trade Center. The Project Bioshield Act was intended to better prepare the US for a bioterror assault, and appropriated billions to stockpile countermeasures against a variety of known pathogens. The legislation also allowed the FDA to authorize unapproved products for emergency use against a threat to public health to help the healthcare system treat victims and minimize spread. However, the road to regulatory hell is well paved with governmental good intentions, and the COVID-related EUA process proved that point more quickly than anticipated.

The FDA issued only 22 EUAs in response to the H1N1 scare in 2009, but as of May 2021 had granted more than 600 authorizations to manufacturers of personal protective equipment, medical devices, diagnostic kits and tests, therapeutics and – most notably and uniquely – vaccines. However, of those 600 authorizations, xxx have been revoked due to quality and/or performance issues, highlighting the risks inherent in offering manufacturers lower testing and validation data requirements. Everything from surgical masks to IVD testing kits to proposed therapeutics have had EUAs revoked after real-world data indicated that the product was not performing to specification.

Alas, all good things must come to an end, and in March, overwhelmed with the sheer volume of applications, the Center for Devices and Radiologic Health (CDRH) stopped accepting new EUA applications. CDRH also began terminating pending EUAs across a wide range of product categories, leaving manufacturers with little recourse but to submit a full 510(k).

The 510(k) Turtle Wins the Race

Manufacturers with pending EUAs that have been terminated have no legal recourse, because the decision to stop accepting applications rests solely with the FDA. The only option open to these manufacturers is to continue toward a complete 510(k) submission and hope for market clearance. From the start, the FDA had strongly suggested that manufacturers consider preparing a full 510(k) in tandem with their EUA application, because any product granted an EUA must submit a complete 510(k) to remain on the market after the emergency ends. Those manufacturers who chose to go the full 510(k) route instead of the abbreviated EUA may win out in the end – and here’s why.

In the early days of the pandemic, face masks flooded the market as the demand increased, and the FDA issued an EUA for the use of masks as personal protective equipment. However, it was not clear what constituted an acceptable mask – surgical mask, N95 mask, that calico covering your grandma made for you – and masks of all types were submitted to the FDA for authorization. As the FDA began to realize that much more clarification was needed as to what constituted an acceptable mask, they issued a series of changes that demonstrate why choosing to go full 150(k) might have been the wiser decision:

• April 16, 2020 – FDA issues an EUA for the use of face masks as personal protective equipment
• April 24, 2020 – FDA amends the EUA, removing surgical masks, which require a 510(k) per 21 CFR 878
• May 2020 – FDA revises its Enforcement Policy from March, removing the 510(k) requirement for surgical masks, provided the masks comply with the remainder of the policy
• August 5, 2020 – FDA issues EUA for certain disposable, single-use masks and increases the testing requirement for surgical masks to include biocompatibility testing
• August 18, 2020 – FDA holds a webinar to clarify the Enforcement Policy, emphasizing that an EUA is not required for surgical masks as long as they comply with the policy

Adding to the confusion, the FDA still referred manufacturers to a 2004 standard that required four different validation tests – fluid resistance, filtration efficiency, breathability, and flammability – that, while intensive, still saved manufacturers a boat load of money. However, as the pandemic raged on and more and more non-compliant masks were identified, the FDA changed their testing requirements. By the time of the August 18 webinar, the FDA had expanded the requirements, tripling the amount of validation testing required and including a requirement for biocompatibility testing of the mask. Now, testing that had previously cost manufacturers around $35,000 to complete now cost $150,000 or more, and only one validation test separated the EUA process from the 510(k). That previously “cheap and easy” EUA path for masks suddenly equaled the expense of a full 510(k), which would be needed anyway once the public health emergency ended, so why not go straight to the 510(k) and save time, money, and aggravation?

The Choice is Still Yours

Not only did the EUA offer a quicker path to market, but it was also less expensive. The testing requirements for a standard 510(k) can be costly as well as time-consuming, so anyone with a beneficial new product stood to save a boat load of money by going the EUA route. But as the “simple” face mask demonstrates, the EUA option was not necessarily cheaper or more straightforward than submission for a traditional 510(k) pre-market notification.

Of course, as COVID recedes from the front page and HHS calls a close to the public health emergency, the EUA process with be shuttered and will no longer be an option. But history has proven that even if the EUA is being tabled for now, it will be revived again at some point in the future, when the next pathogen comes along to threaten the populations’ health. However, slow and steady wins the regulatory race, so manufacturers would be well advised to consider bypassing the uber-attractive EUA process and taking the time to go the full 510(k). Your FDA submission budget will thank you.