Article 10a comes into effect

Article 10a of the MDR requires medical device manufacturers to give the authorities advanced warning of potential supply-chain issues. Introduced by Regulation (EU) 2024/1860, it took effect on January 10th, 2025. 

But what does this mean for medical device companies? 

There is now an obligation to report interruptions or issues in your supply chain. The authorities must be notified 6 months ahead of the issue arising. It’s something that will almost certainly be checked by your Notified Body in future audits. 

For example, imagine a critical component of your device becomes unavailable. This could massively impact your production and distribution capability, and therefore the delivery of your medical device to customers and patients. Ultimately, this amendment enables healthcare providers to plan ahead by getting advanced warning of limited availability or slower product delivery times. 

As medical device manufacturers may not have the tools to accurately predict supply chain issues months in advance, there are exemptions to the rule. An unforeseen pandemic is a good example of a scenario where manufacturers have minimal insight into disruptions.

Increased data entry into EUDAMED

The European Database on Medical Devices (EUDAMED) provides a live and transparent view of the full lifecycle of all devices on the EU market. So far, data has slowly trickled into the system. From 2025 onwards, economic operators will be required to add more specific information to the database. The first three modules are already live and accepting the following data: 

1. Actor registration
2. Unique Device Identification (UDI) and device registration
3. Notified Bodies and certification

Further modules, set to go live in 2026, are related to clinical investigation and performance studies, vigilance, and post-market surveillance. In readiness for the post-market surveillance requirement, you’ll need a suitable market summary for devices in the higher risk classes. If your product is already on the market, it’s likely that you’ve already prepared a sufficient executive summary or something that can be easily adapted and/or expanded. For more information on specific guidance, refer to the official MDCG documents, such as the PMCF Plan (MDCG 2020-7), the PMCF Evaluation Report (MDCG 2020-8), and the PSUR guidelines (MDCG 2022-21).

While a lot of guidance on EUDAMED is widely available, much of it will soon become outdated. As a medical device manufacturer, it’s imperative to keep an eye out for new guidance documents as they’re released over the next year or so. 

Upcoming deadlines and potential changes

It’s also important to remember that some MDR deadlines, which were previously extended, will take effect in the next few years. For example, high risk products must fully comply with the MDR by 2027, while low and medium risk products must comply by 2028. Those deadlines will come around quickly, and time is running out to prepare your files given that Notified Body approval mostly take 1 year or longer.  

The first consultation on potential improvements and amendments to the MDR opened in 2024 and remains open till 25 March 2025. Its main purpose is to identify gaps and issues with the implementation of the MDR around aspects such as the administrative burden and the cost of compliance – particularly for small and mid-sized companies with fewer resources at their disposal.  

The goal is to find ways of improving and streamlining specific processes within the MDR. For example, there have already been calls for greater consistency and transparency over the pricing structures of Notified Bodies and also equal instructions from competent authorities how Notified Bodies should check for compliance. At the same time, there have been calls for better guidance on products which fall into more obscure categories – such as orphan devices. 

There’s already been a motion to ‘urgently revise’ the content of the MDR from some of the major players in the medtech industry. So far, public feedback seems to be heavily infused with political commentary as opposed to content-based suggestions for moving the MDR forward. 

Whatever the outcome of the consultation, it will almost certainly lead to updated guidance or regulatory amendments in the next few years. That could mean that deadlines change, especially with the additional layer of compliance work created by the EU’s AI Act.

Upcoming deadlines for adding UDIs to product labels

The requirement to add UDIs (Unique Device Identifiers) to product labels has been phased in over the last couple of years. It started in 2021 with first Class III in 2023 Class IIa and b medical devices and continues in 2025 with Class I products (before May 26th) . 

Companies that already include UDIs on all their product labels will not need to take any further action. Those without  will need to display UDIs on their product labels no later than May 26th, 2025. 

Certain devices do not yet officially require a UDI, including MDD legacy and reusable Class I   devices. But bearing in mind the simplicity of the process for obtaining a batch of UDIs and registering them on the EUDAMED database, it makes sense to put this on product labels from day one, also because all devices need UDIs by 2027.  

The impact of the AI Act on medical devices

One of the biggest regulatory changes impacting medical device manufacturers from 2025 onwards is the EU’s AI Act. Here are a few key dates coming up in the next two years: 

• February 2nd, 2025 – AI-powered systems that pose an unacceptable risk will be banned, such as AI tools that could discriminate against certain demographics.
• August 2nd, 2025 – Developers of general purpose AI – Large Language Models (LLM) like ChatGPT – will be required to meet the requirements of the AI Act. 
• August 2nd, 2026 – An important date for developers of Software as a Medical Device (SaMD). From this date onwards, high-risk AI systems – including medical devices with AI-powered components – must comply with the AI Act.  

The key takeaway right now is not to underestimate the time needed to rewrite your technical dossier so it takes account of the new legislation and meets the requirements for a  CE mark. 

 Get started on tomorrow’s compliance – today

What’s one thing we’ve learned from helping medical device companies – like yours and ours – with certification under the MDR? It’s best to start your compliance journey today instead of postponing it until tomorrow. The reason is simple: it buys you more time to get things right and to understand the cost and time structure well in advance.

If that sounds like an overwhelming challenge, it doesn’t have to be. You can always look outside your organization for specialist support with regulatory compliance. For example, if you’re launching an innovative medical device product containing AI, we recommend ISO 42001 – Information technology — Artificial intelligence — Management system. As well as all the other complexities of regulatory compliance for medical devices, that’s something the experts here at Peercode Regulatory Consultancy can help with. 

Interested in how we can help you navigate the complexities of the MDR and AI Act? Speak to one of our friendly experts today!