The deadline for MDR compliance was extended

Earlier in 2023, we reported that the EU extended the timelines for compliance with the MDR. The extension was largely due to the backlog of unprocessed certifications. Notified Bodies were struggling to keep up with demand and there was a very high risk that products – previously approved under the MDD – would be pulled from the market because they were not yet certified under the MDR.

To make use of the extended deadlines, companies need an MDR-compliant Quality Management System (QMS) in place by the 26th of May 2024. Furthermore, manufacturers should formally submit an application to a Notified Body for the device before this date. Taking these steps makes it possible to keep manufacturing and marketing MDD-certified products until 31st December 2028 – as long as the product stays the same. Any changes to the product will require MDR certification. 

Higher risk products have the earliest deadlines for compliance with the MDR. Class III and IIb products need to be certified by 31st of December 2027, Class IIa and Class I special by 31st of December 2028. If you’re looking for ways to expedite the documentation needed, our guidance on how to get a product certified on time may be of interest to you.

Another important aspect to the extension is the EU’s removal of the deadline for ceasing MDD-certified products by the end of 2028. Now, the sale of MDD-certified medical device products, which have already been manufactured and stored, can continue indefinitely beyond 2028. This is good news for manufacturers with MDD-certified products and backlogs of stock to clear.

What’s important to remember about the extension deadline is that the queue for MDR certification is still long. It can take up to 2 years to get approval. So it’s essential to get started, and get it done. In a competitive market, no-one wants to be at the back of the queue! 

Having an MDR-certified product has a number of strategic advantages – tangible business benefits – as we covered in our blog on the added value of MDR compliance. For example, some healthcare providers will only procure MDR-certified products. Likewise, many insurers will only insure products with the most up-to-date certification.

Compliance is complicated, but it doesn’t need to be stressful. The great thing about bringing in regulatory consultants from Peercode to help you is that our own SaMD products are already MDR-certified. We’ve been there, and done that. So we’re one step ahead. 

There was important new guidance from the MDCG

As part of our ongoing services to medical device companies, the consultants at Peercode regularly review changes to guidance documents from the MDCG. We also review the guidance from the perspective of our own medical device products – featured in our guide to creating MDR-certified software. 

Guidance documents explain different aspects of the MDR in more detail, particularly gray areas where problems have arisen. They also provide examples to support understanding. The guidance for borderline products is especially helpful for determining whether something is a medical device. Here’s the important thing about guidance documents: they’re viewed as mandatory. For that reason, it’s advisable that medical device companies study them, identify anything applicable, and take the appropriate action. 

MDCG2023-1

The very start of 2023 saw an update to health institution exemptions in MDCG2023-1. In-house medical devices are generally exempt from most provisions of Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), except for the general safety and performance requirements outlined in Annex I. 

To qualify for exemptions, health institutions must meet conditions specified in Article 5(5) of the regulations. The latest guidance explains the terms in Article 5(5), clarifying which devices are covered and emphasizing compliance with relevant safety and performance requirements. A significant portion of the document focuses on defining an appropriate Quality Management System (QMS) for in-house devices, detailing areas such as risk management and traceability with illustrative examples.

MDCG 2023-2

MDCG 2023-2 focuses on creating transparency regarding fees charged by Notified Bodies, as required by the MDR and IVDR. This guidance emphasizes that fees should be easily accessible on the Notified Body's website without the need for registration or contact details. The document provides a table outlining how Notified Bodies can present their fees, covering factors like fee structure, range, travel-time costs, and administrative expenses for various assessments. 

MDCG 2023-2 aims to encourage best practices in fee presentation, allowing the public to make informed decisions. Notified Bodies typically follow MDCG guidance as best practice, and changes may take up to 12 months from the publication of such guidance. The guidance raises the question of when Notified Bodies will publish their fees, potentially fostering peer pressure for compliance with fee transparency.

MDCG 2023-3

In February 2023, new guidance was released explaining terms and concepts necessary for effective and harmonized implementation of the vigilance requirements under the MDR (MDCG 2023-3). It helps clarify key terminology and concepts that’s really important for medical devices, and our advice is to read it carefully. 

This update impacts the majority of medical device companies who may need to update their procedures around what to do when things go wrong, including abnormal use, user errors, and side effects. 

MDCG 2023-4

In October 2023, MDCG 2023-4 was released for software that needs hardware or a hardware component to achieve its intended medical purpose. One example could be a smartphone app that patients use to check their skin. The software uses the phone’s camera to take a picture, which can then be shared with a doctor. In this case, off-the-shelf hardware has a role, but it’s outside the control of the medical device software vendor.

In our example, the vendor needs control over every type of smartphone hardware that could run their software. This means they would need to consider variables such as the make and model of phone, the OS version, and the built-in camera hardware. It’s clear that the volume of configurations available make this an almost impossible task. And, whilst it raises important questions – and makes future revisions of the guidance more likely – the key takeaway is simple: if a SaMD needs hardware to fulfill its intended purpose, vendors have to take responsibility to document this, before it goes to market. 

Of course, if the phone hardware is not needed to achieve the intended purpose, then this simplifies things. However, it’s still important for vendors to document the compatibility of their software with different devices and OS, producing a maintenance plan that states which devices and OS devices they will support and for how long. Alongside this, it’s a good idea to have a complaints handling procedure in place for the unlikely event that a user has a configuration issue that wasn’t taken into account.

MDCG 2023-5

MDCG 2023-5 clarifies how products lacking a defined medical purpose can still adhere to qualification and classification requirements outlined in the MDR. Offering manufacturers examples and insights, the document emphasizes that provided examples don't automatically categorize products as devices; classification rules come into play after confirming the product’s device qualification. 

The guidance suggests using it alongside MDCG 2021-24 and considering EU Regulation 2022/2347 on reclassification. It highlights that product qualification depends on information in Annex XVI and the CS’s scope sections, emphasizing similarities with analogous medical devices in function and risk profile. 

For accessories to nonmedical purpose products, the guidance states they fall under MDR if they align with Annex XVI and the CS’s regulated product definition. It distinguishes between accessories used with the main product (considered part of it) and those functioning independently (classified as stand-alone products) when entering the market.

MDCG 2023-6

MDCG 2023-6 dives into demonstrating the equivalence of nonmedical purpose products to those already on the market, leveraging relevant data. While clinical investigations are a direct route to CE marking data, the guidance emphasizes the option of demonstrating equivalence using data from similar devices. 

It categorizes equivalence demonstrations into three types. For products without an intended medical purpose compared to similar ones, clinical data should show equivalency based on technical, biological, and clinical characteristics, considering certain clinical aspects in the context of medical purpose. 

However, comparing nonmedical purpose products with analogous medical devices presents challenges due to differing clinical characteristics, making equivalence establishment unfeasible. In the third category, the guidance suggests demonstrating equivalency between nonmedical purpose products and devices with both medical and nonmedical purposes, emphasizing reliance on the nonmedical characteristics of both devices.

MDCG 2023-7

MDCG 2023-7 outlines specific criteria for exempting certain devices from clinical investigations, with a strong emphasis on prioritizing patient safety and data integrity. It provides a detailed process for demonstrating equivalence between new Devices Under Evaluation (DUE) and existing devices, requiring comprehensive data and analysis.

Manufacturers are encouraged to have substantial access to and effectively utilize data to support claims of equivalence without relying solely on traditional clinical trials. The guidance highlights the unique and case-specific nature of exemption criteria, advocating for a tailored approach to meet diverse regulatory requirements. Additionally, it underscores the importance of collaborative efforts between manufacturers, emphasizing contractual agreements as crucial tools for accessing technical documentation necessary for proving equivalence.

MDCG guidance document revisions

Several MDR-related MDCG guidance documents were revised in 2023, including MDCG 2021-6 Rev.1, MDCG 2021-27 Rev.1, MDCG 2020-3 Rev.1, MDCG 2022-18 Add.1, and MDCG 2022-11 Rev.1. These revisions cover topics such as clinical investigations under MDR, Q&A on economic operators, conditions for legacy devices, limitations on Article 97 MDR, and the certification process. Emphasis is placed on clarifications, updates, and aligning with regulatory changes, providing valuable insights for stakeholders in the medical device industry.

AI has entered the world of medical devices 

Medical device companies that have implemented forms of AI within their medical devices can prepare for the EU AI Act by staying informed on the latest guidance for medical devices. Aligning with the MDR’s focus on user instructions, companies need to ensure clear user controls. It’s also important to leverage existing MDR compliance procedures for risk management, validation, and surveillance activities to benefit from streamlined processes under the AI Act.

At the same time, companies should implement post-market surveillance (PMS) for scheduling AI updates and performance checks, ensuring proactive control over its behavior. Given AI’s reliance on data, it would be wise to anticipate overlap with the General Data Protection Regulation (GDPR), acquiring regulatory knowledge in this area to identify and address compliance gaps. 

Taking a proactive approach to AI implementation in medical devices will help companies prepare for a smooth transition when the AI Act takes effect. For example, look into the implementation of the recently released ISO/IEC 42001, a standard for establishing, implementing, maintaining, and continually improving an Artificial Intelligence Management System. Discover more about this topic in our blog on the impact of AI and Machine Learning on medical devices.

What’s in store for 2024?

Changes to the MDR in 2023 present tough challenges for both existing and new medical device manufacturers for 2024 onwards. 

Delays and increased workload for Notified Bodies, stricter requirements for certification, and a range of changes and updates create hurdles for companies seeking market access. For some medical device companies, the extended timelines for compliance will not be enough to help them overcome these challenges. They’ll need more support.

For that reason, manufacturers are encouraged to act quickly, collaborate with Notified Bodies, and develop comprehensive strategies to ensure compliance with the MDR requirements, including meeting deadlines, collecting necessary data, and navigating the complex certification process. That’s especially important for makers of medical device software, with the arrival of the AI Act in 2024.

At the same time, industry groups are advocating for comprehensive changes to the MDR framework to improve efficiency, support innovation, and strengthen governance, emphasizing the need for coordination between authorities, manufacturers, and Notified Bodies for successful implementation.

In 2024 and beyond, additional guidance and accelerated harmonization efforts will provide a smoother path towards the MDR-certification – especially as only one standard was harmonized in 2023 (EN ISO 10993-10:2023). Medical device companies can also lean into regulatory expertise to ensure smoother and more streamlined compliance with the MDR. 

At Peercode Regulatory Consultancy, we help medical device companies successfully navigate the relevant regulations, so they stay compliant no matter what the future holds. Speak to a specialist