Does the requirement for an independent person at design reviews no longer apply?

The FDA’s recent implementation of the Quality Management System Regulation (QMSR) introduces significant changes. Notably, one of those changes is that the QMSR does not explicitly mandate the presence of an independent reviewer during design reviews.

In the current QSR 820.30 Design Controls, Section (e) Design review, FDA clearly outlines that: “The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed.”

Since the new QSMR directly refer to ISO 13485:2016 in this section without any additions, the future requirement in section 7.3.5 Design and development review: “Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel”, can suddenly become a free card. Specifically for small companies that struggle to find a person that is both independent but also competent enough to add value to the review.

In the FDA Medical Devices; Quality System Regulation Amendments you can read FDAs response to this on Comment 46. The FDA concludes that the section in 13485 about “specialist personnel” also could include “the important contribution of independent review”.
It can therefore be reasonably assumed that even after February 2, 2026, the FDA will anticipate the presence of an independent reviewer. This expectation isn’t solely due to regulatory mandates but rather reflects a widely recognized industry best practice. And even though the standard itself does not mention independent reviewers, the 13485 Handbook (ISO 13485:2016 – Medical devices – A practical guide) describes that design and development reviews are not conducted just by the team directly but should also include independent reviewers.

As FDA so eloquently put it, the independent reviewer adds an important contribution, such as a fresh perspective to matters and can challenge general assumptions made by the design and development team. It is also easy to be “blind to flaws at home” when you are deeply involved in a project. Taking a new perspective could reveal mistakes, oversights, or discrepancies in testing outcomes. Surprisingly often the independent reviewer finds issues that need to be corrected and sometimes this even makes the design better and safer.

Conclusion is that an independent reviewer is a vital asset during design reviews and should be handled as such. It’s not just to “tick a box”. Otherwise, the first “independent reviewer” of your technical file will be the FDA, Notified Body or a Regulatory Authority. This might not be the most preferred option as it may affect your product approval and delay your launch to the market.

If you have any question, contact us at info@qadvis.com.

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Can supply problems potentially result in shortages of medical devices in hospitals?

In recent years, significant disruptions in global supply chains have had a huge impact on worldwide trade. These disruptions highlight the need for enhanced resilience and adaptability in the procurement processes especially in the medtech industry.

The vulnerabilities of our supply chains were notably exposed during the COVID-19 pandemic, which led to unexpected closures of manufacturing and distribution facilities, all while the need for medical supplies increased.

During the second half of 2020 there was an emergence of semiconductor shortages, causing many companies in the medtech industry to struggle with finding replacement parts. Then in March 2021, the Japanese ship Ever Given became lodged in Egypt’s Suez Canal, blocking one of the world’s busiest maritime routes and causing substantial disruption to global trade. More recently, escalating conflicts in the Middle East, have also caused significant disruptions to commercial shipping.

These examples illustrate the complexity and vulnerability of global supply chains prompting health regulatory authorities worldwide to take action.
In the European Union, several steps have been taken to manage supply chain disruptions like reinforcing the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.

In the United States, the FDA has introduced mandatory notification requirements. This requires manufacturers of certain devices to notify the FDA of a permanent discontinuance or an interruption in manufacturing that could lead to a significant disruption in the supply of critical devices. The FDA also encourages manufacturers of other types of devices to voluntarily notify them of any manufacturing interruptions or discontinuances.

In Canada, recent updates to the Medical Devices Regulations mandate manufacturers and importers to disclose any shortages or discontinuations that could potentially result in a shortage of medical devices that are listed on the Notification of Shortages.

In Australia, the Therapeutic Goods Administration (TGA) employs a risk-based approach to medical supply shortages. The TGA monitors national supply disruptions of critical devices and collaborates with impacted stakeholders to mitigate the consequences. Although there is no mandated obligation for manufacturers to report potential medical device supply disruptions, the TGA encourages sponsors to notify them of any such potential disruptions.

Manufacture of critical medical devices and obligations to report shortages and discontinuations of medical devices can significantly influence your Quality Management System. Regulations like section 506J of the FD&C Act and amendments to the Medical Devices Regulations necessitate manufacturers to alert authorities about any permanent discontinuation or disruption in the production of a device that could lead to a significant supply disruption and contribute to care delays or even denial of care. Non-compliance could result in regulatory actions.

Your QMS shall incorporate a robust risk management process to identify and mitigate these risks, for example by implementing strategies to prevent or mitigate supply shortages. Mitigations could for example be diversifying suppliers or maintaining sufficient stock levels.

Lastly, you should have a clear strategy for effectively communicating with healthcare providers, patients, and regulatory authorities about potential shortages.
While health authorities bear the overall responsibility for national medical device supplies, manufacturers also hold a crucial role in preventing and mitigating the impact of medical device shortages through effective communication and cooperation.

If you have any question, contact us at info@qadvis.com.

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Join us at the Swedish Medtech Regulatory Summit on 14 March 2024

QAdvis will attend the yearly Regulatory Summit hosted by Swedish Medtech. This year Robert Ginsberg and Cecilia Emanuelsson will be two of the speakers.

We look forward to attending this annual meeting and to be a part of the presentations and meet all the participants. Cecilia Emanuelsson and Robert Ginsberg will share their knowledge and experience within Clinical strategies and medical device SW regulations.

Come and talk to us at the booth or connect to us via the digital platform.

We look forward to meeting you there.

More information here (Swedish).

 

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Regulators will regulate, and AI is on top of their list.

The EU AI Act will become the world’s first broad legal framework for artificial intelligence and could hopefully become a global standard. It will apply to any business operating within the EU or offering AI systems or services to EU residents.

The use of artificial intelligence in the EU will be regulated by the AI Act, the world’s first comprehensive AI law. Currently the European Parliament is actively working on finalizing the regulation to ensure safe and ethical use of AI within its member states. Intention is to cover all sectors and all types of artificial intelligence except for military use. The European Commission proposed the AI Act in April 2021, and the commission has in December 2023 reached a provisional agreement. The agreed text will now have to be formally adopted by both Parliament and Council to become EU law. The Act is intended to be adopted during 2024 and enter into force after a transitional period of 2-4 years.

Title I in the proposal defines the subject matter of the regulation and the scope of application of the new rules that cover the placing on the market, putting into service and use of AI systems. The definition of AI system in the legal framework aims to be as technology neutral and future proof as possible, taking into account the fast technological and market developments related to AI. The Act uses a risk-based approach in four classes to set up different requirements depending on the level of risk an AI system poses to human health, safety, or rights.

  1. Prohibited artificial intelligence practices (title II)
    Some AI uses are banned, such as subliminal manipulation, social credit scoring, or real-time biometric identification.
  2. High-risk AI systems (title III)
    Permitted but subject to compliance with AI requirements and conformity assessments. This would include biometric identification, medical devices, law enforcement, critical infrastructure, and many others.
  3. Transparency obligations for certain AI systems (title IV)
    Permitted but subject to information/transparency obligations. This basically means that humans must be notified that they are interacting with an AI and what it does.
    It applies to systems that:
    – interact with humans,
    – are used to detect emotions or determine association with (social) categories based on biometric data, or
    – generate or manipulate content (‘deep fakes’).
  4. Minimal or no risk
    Permitted with no restrictions. No mandatory requirements but the commission proposes voluntary requirements to be developed. This would for example include ChatGPT.

Europe has with the AI act taken a big step in creating a general law on AI while regulation in the US is still evolving. The FDA has been developing a new regulatory approach for AI/ML-enabled medical devices that is based on the principle of “total product lifecycle” (TPLC). This means that the FDA would monitor and evaluate the performance of AI/ML-enabled medical devices throughout their lifecycle, not just at the point of premarket approval. The FDA also plans to establish a Medical AI Evaluation Database (MAIED) to collect real-world data on AI/ML-enabled medical devices.

The lack of common requirements in the EU and US could result in one of two situations. The first, and obviously the preferred one is that US regulators take a good look at the AI Act and align the requirements accordingly. The other scenario with a set of different rules would be both cumbersome and costly for industry and healthcare alike.

The future will tell how this will evolve but we can be certain that the use of AI will significantly affect every aspect of our society in the same way, and beyond, what the development of computers once did. And much like with computers, if you miss the queue to step onboard, you might miss the train entirely.

In the final episode of this article series, we will try to extrapolate where the AI journey might take us and glance into the future.

If you have any question, contact us at info@qadvis.com.

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