The COVID-19 pandemic has had a profound impact on public health and the economy worldwide. In response, the US Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) to accelerate the availability of medical products needed to address the pandemic. As the public health emergency declaration approaches its expiration date in the US, it’s important to understand how this impacts EUAs and the availability of medical products.

An EUA is a regulatory mechanism that allows the FDA to authorize the emergency use of medical products during a public health emergency. Under an EUA, medical products can be used for their intended purpose, even if they have not undergone the typical rigorous testing and approval process. The EUA mechanism was used extensively during the COVID-19 pandemic to make medical products, such as vaccines, available to the public in record time.

The public health emergency declaration was first issued in the US on January 31st, 2020, and has been extended several times since then. The current expiration date for the declaration is May 11th, 2023. The expiration of the public health emergency declaration does not mean that all EUAs will be revoked, but it does mean that the FDA will no longer have the authority to issue new EUAs.

Medical products that have already received an EUA will remain available for emergency use, but they will be subject to ongoing review and evaluation by the FDA. This means that any potential safety concerns that arise with EUA products will continue to be closely monitored, and the FDA may take action to modify or revoke the EUA if necessary.

While the expiration of the public health emergency declaration does not automatically revoke existing EUAs, it may impact the availability of some medical products. For example, some manufacturers may choose to discontinue production of products that were only authorized under an EUA once the declaration has expired. This could result in supply chain disruptions and impact the availability of certain medical products.

In conclusion, the expiration of the public health emergency declaration in the US does not mean that all EUAs will be revoked, but it does mean that the FDA will no longer have the authority to issue new EUAs. Medical products that have already received an EUA will remain available for emergency use, but ongoing evaluation and monitoring will continue to ensure their safety and effectiveness. The impact on the availability of medical products will depend on a variety of factors, including the willingness of manufacturers to continue production and ongoing regulatory oversight.

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By Lily Vucenich  |  July 17, 2022

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.

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Many guidance documents exist on these topics and MDR submissions The MDCG documents are particularly important references to use when writing your Technical File and supporting evidence documents.

The submission review/ QC check is NOT a waste of time. If you are performing this step, you are potentially wasting months of time.

Have open dialog with your NB scheme manager to ensure your approach matches their requirements.

Aspects Fang can assist with:

• Full or partial drafting of submissions/technical evidence documents
• Independent QC check of submissions/technical evidence documents
• Regulatory Strategy
• Gap Assessments including evidence reviews
• Answering NB non-conformance questions

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If you manufacture medical devices for sale in the European Union, you’ll have to show that they conform to the EU’s new Medical Device Regulation (MDR). How you demonstrate conformity depends on how big a risk your device presents to patients. For devices that pose the greatest risk – devices that European regulations designate as class IIa, class IIb, and class III – you have to engage a Notified Body (NB), a third-party organization that assesses your device’s fulfillment of the EU’s requirements on behalf of an EU member state.

But what if the device you want to sell in Europe belongs to class I, the lowest risk class under MDR? If you had experience with the now expired Medical Device Directive (MDD), you may be familiar with the concept of manufacturers “self-certifying” class I devices, without requiring a conformity assessment by an NB.

So what’s the situation under MDR? Does “self-certification” still exist for class I devices in the regulations?

Well, according to MDR, there are class I devices, and then there are class I devices….

If your class I device –

• is not sold sterile,
• does not have a measuring function, and
• is not a reusable surgical instrument,

then MDR does provide a pathway for you to “self-certify” it. (As for what that process entails – that’s a topic for another time.)

But what about the class I devices that are sold sterile, that do have a measuring function, or that are reusable surgical instruments? As we take each in turn, you may pick up on a pattern:

If your class I device is sold sterile, then you do need an NB – though not to perform an entire conformity assessment, but only to review how you establish, secure, and maintain sterile conditions. (Sterile class I devices are known informally, by the way, as “class Is;” see guidance document MDCG 2019-15.)

Similarly, if your class I device has a measuring function, you need an NB – but only to review how you ensure conformity with the device’s metrological requirements. (Class I devices with a measuring function are known informally as “class Im.”)

And if your class I device is a reusable surgical instrument? You need an NB – but only to review aspects relating to the reuse of the device, especially cleaning, disinfection, sterilization, maintenance and functional testing, and the relevant instructions for use. (As you may have guessed by now, class I devices that are reusable surgical instruments are known informally as “class Ir.”)

If all of this is new to you or your company, the Fang Team of consultants can partner with your regulatory team and answer any questions they may have. We have experience with the EU regulations and can help assess any gaps your documentation may have. Contact us today.

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Tracy Eberly and Fang Consulting acknowledge that one of the most important markers for deciding if a medical device consulting firm is the right fit is whether they have worked with your device classification previously. The importance of experience with medical devices that your company specializes in is clear, as it difficult to ensure proper regulatory and quality management if your medical device consulting firm has no prior experience with your device space. On the other hand, medical device consultants that have worked with offerings that are like yours will have a much better grasp of logistics such as applicable standards in the space as well as specific guidance documents.

Tracy Eberly and Fang Consulting have experience serving a variety of different sized companies, ranging from startups, midsized, and billion+. To this point, Tracy Eberly and Fang Consulting acknowledge that the needs companies have vary largely based on their size and goals. For example, startups may need to be advised on crucial, integral steps such as regulatory submissions and QMS system developments to establish a strong foundation and room for growth. As a medical device company, it is crucial to work with consultants that have experience operating within the scope of businesses that are your size and at your stage of development. Some startups, for instance, hire consultants that mainly have experience with larger companies, only to find that their experience is not necessary before they have devices in commercial distribution. A mismatch such as that example could pull key resources away from critical activities that are more pertinent to what you company needs to be successful.

Expertise in both your area of specialization and business size are crucial, however Tracy Eberly and Fang Consulting note that some facets of choosing a consultant can be more subjective in nature. For example, one cannot discount the importance of selecting an advisor or consultant that you feel as though you can trust. A great way to determine how comfortable you feel with a consultant is by remaining aware of how they engage. You certainly want to have members on your team that have some level of humility, can admit if they are wrong, and can hear out other opinions as they relate to strategy. This ability to be flexible defines the medical device consulting space and is a coveted trait for those that are looking for a consultant that can bring their company and offerings to new heights.

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With the EU MDR (2017/745) replacing the current MDD (93/42/EEC) in the EU, many changes are on the horizon and will improve and modernize the current system to ensure the safety of devices. Some of those major changes are the requirements Notified Bodies must conform to once the MDR is in full effect.

With the changes the MDR is enforcing, Notified Bodies “are required to now demonstrate increased, more granular technical experience in their scope of designation, as well as improved quality management systems” (Brooks). They will be audited by Competent Authorities and EC representatives, and can expect more regular and consistent audits. The changing requirements have led to a decline in the number of active Notified Bodies. In October 2017, the number of Notified Bodies was reported to have dropped from over 83 active Notified Bodies to around 52 (Brooks).

One issue current Notified Bodies face is the ability to staff for the coming changes. Active Notified Bodies need to hire, train, and increase competency of the new regulations, affecting their current workloads. Notified Bodies need to manage current workload while actively hiring and training auditors to meet the new requirements, with training new auditors taking up to a year. This has had an impact on current active Notified Bodies, as the MDR comes with a greater emphasis on more regular and thorough reviews of data and documentation held by compliant device companies (Brooks; Maxwell).

At this time, 23 Notified Bodies, including BSI, DEKRA, and TUV, part of TEAM-NB (The European Association of Medical Notified Bodies), have announced timelines for applying to the new Notified Body designation under the MDR. It is not known if smaller companies will be able to meet the demands of the MDR.
Preparation for the implementation of the MDR is integral, as waiting until the last minute to submit to a Notified Body for review of documentation could result in being part of significant backlogs of documentation requiring review. Manufacturers need to plan accordingly, as the number of active Notified Bodies is shrinking, and workloads are increasing to prepare for the implementation.

Fang Consulting is equipped to help with your documentation needs when transitioning from MDD to MDR. We perform thorough gap analyses on current documentation to identify where changes need to be made, and we update current technical documentation to meet the new requirements. Preparation is key, and Fang Consulting can help your company transition early to the new requirements to avoid rushing to finalize documentation.

Sources:
https://medtech.pharmaintelligence.informa.com/MT122597/Substantial-Drop-In-Certificates-Withdrawn-By-EU-Notified-Bodies-Why-Now
https://www.med-technews.com/features/medical-device-regulation-whats-the-impact-on-notified-bodi/

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