Mason Hayes & Curran LLP sponsored MedTech Summit 2021, the leading event dedicated to accelerating the path to MedTech regulatory compliance. The event took place virtually from 18 -22 October.

Summit Tracks and Courses

To ensure that the sessions were tailored to the specific needs of the attendees, who came from a diverse set of backgrounds and industries, the Summit had 8 different tracks.

These were:

• European Medical Device Regulations

• Legal Advice for Medical Device Regulations

• Drug Device Combination Products

• Clinical Evaluations and Investigations for Medical Devices

• Post Market Surveillance for Medical Devices

• Medical Device Regulations in Global Markets

• EU IVD Regulation and Strategy, and

• Biocompatibility for Medical Devices.

The above tracks featured functionalities to help attendees navigate, accelerate, and maintain regulatory compliance.

In addition, there were focused MedTech training courses on:

• Medical Device Regulatory Project Management, and

• Understanding Labelling and UDI for Medical Devices and IVDs.

MHC Attendees and Speakers

Michaela Herron, James Gallagher, Aisling Morrough, Saadi Siddiky and Siobhán Mazarire from our Life Sciences & Consumer Product Regulatory team attended the MedTech Summit 2021. Michaela and James spoke at a roundtable session on 5 Key Legal Issues for Software Medical Device Manufacturers – EU & UK Perspectives. Additionally, Michaela spoke at a session on Legal Perspectives on the Regulation of Digital Health & Artificial Intelligence.

Key Themes and Takeaways

Regulatory compliance: A recurring theme throughout the sessions was that manufacturers must start early with their regulatory compliance process. The MDR and IVDR are complex pieces of legislation and entail more stringent requirements for all economic operators involved in the manufacture and supply of medical devices, including manufacturers, importers, and distributors. It was reinforced several times that it is not enough for manufacturers to simply update their MDD/IVDD documentation.

Engaging with notified bodies: Another related theme was that manufacturers who are required to engage with notified bodies must do so as soon as possible. Representatives from various notified bodies have been vocal about not leaving the product certification application to the last minute and ensuring that a complete and cohesive application is submitted. In their experience, manufacturers often submit incomplete and rushed applications, which can trigger several rounds of clarifications and queries and prolong the process.

Resourcing: Manufacturers should also ensure proper resourcing within their organisation MDR/IVDR compliance is a complex process, so it is critical to make sure that they have enough manpower to handle this. Consistent feedback from organisations is that they realised, often quite late, how much resources they actually needed to ensure compliance. Some found that having just one person responsible for compliance for the whole organisation and across multiple devices was not enough.

Understanding the legislation and relevant guidance: There were further discussions around how important it is for manufacturers to take the time to read and understand the relevant provisions of the MDR/IVDR, particularly the provisions around technical documentation and quality management systems. In addition, manufacturers should make sure that they review and understand not only the MDR/IVDR, but also related guidance documents. This is important as the role of notified bodies does not extend to providing consultancy services.

Managing regulatory intelligence: For MDR/IVDR compliance, manufacturers were advised to have an internal process in place for managing regulatory intelligence. The need to expend resources on this was highlighted several times. It is important for manufacturers to use intelligence to prevent adverse situations. The reality, it was said, is that most companies rush to get regulatory or market intelligence only when they are in difficulty. This is often done, for example, just before audit, or when there is a recall/investigation/queries from regulatory bodies.

EUDAMED: There were multiple sessions on EUDAMED where it was repeatedly noted that EUDAMED should not be underestimated as it is very complex. So, as with the other areas of medical device legislation, it would be critical for manufacturers to start familiarising themselves with the portal and registering early. Currently, only three of the six modules of EUDAMED are functional. The legislation states that registration is voluntary until EUDAMED is “fully functional”. However, some sessions flagged that the Commission could issue implementing acts to clarify the meaning of “fully functional”. For instance, it could say that EUDAMED is fully functional once the fourth module goes live. As such, manufacturers were advised against waiting for the last two modules. It was made clear that they should start now.

Managing corporate acquisitions: For corporate acquisitions involving medical devices, it is important to seek regulatory input. This is particularly critical in the due diligence process. Acquirers must ensure that the target producers hold relevant MDR/IVDR certification or are making use of the transitional provisions in that legislation properly. Transactions have been known to have been put on hold pending regulatory approval. Because of this, regulatory issues can have impact on completion timelines as well as the drafting of the transaction documents, e.g., long stop dates in share purchase agreements.

Brexit convergence and divergence: The repercussions and effects of Brexit are still being felt. There were discussions during the Summit as to whether the UK will converge or diverge with the EU as it moves towards an overhaul of its medical device regulations. The recently published MHRA consultation illustrates broad convergence with the EU. However, there are certain areas where the UK is planning to diverge e.g., new novel routes to market, the introduction of an “airlock classification rule” for Software as a Medical Device and an increased emphasis on environmental sustainability measures.

Mark your calendar for 20-24 June 2022 and join us again next year for MedTech Summit 2022. We look forward to seeing you there.

For more information, contact a member of our Life Sciences Team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.