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Medical devices and IVD's - The Main Regulatory Changes in 2024

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Laura Friedl-Hirst, Founder, Managing Director and Principal Consultant at LFH Regulatory discusses the main regulatory changes in the UK and the EU over the past 12 months.

The requirements for medical device and in vitro diagnostic are constantly evolving, especially with changes such as the United Kingdom’s (UK) departure from the European Union (EU) following Brexit and the introduction of Artificial Intelligence (AI).  Keeping up with compliance requirements can be daunting for those developing or selling such products for the EU and UK.  

This year has seen numerous regulatory changes and updates, highlighting the lack of regulatory structure in the UK and the publication of many Medical Device Coordination Guidance (MDCG) documents to help manufacturers navigate and comply with EU legislation where regulations have been unclear.

As we approach the end of 2024, it is crucial to reflect on some of the main changes for both regions and understand the potential impact on businesses.

United Kingdom

In January, the UK introduced legislation allowing CE-marked medical devices to be placed on the Great Britain (GB) market.  Transitional timeframes for accessing the GB market with CE marked devices are as follows:

  • General Medical Devices compliant with the Medical Devices Directive 93/42/EEC (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) with a valid declaration and CE marking can be placed on the market until the sooner of the certificate’s expiry or 30 June 2028.
  • IVDs compliant with the In Vitro Diagnostic Directive 98/79/EEC (IVDD) can be placed on the market until the sooner of the certificate’s expiry or 30 June 2030.
  • General Medical Devices and IVDs.  Medical devices including custom-made devices, compliant with the EU Medical Device Regulation 2017/745 (MDR) and IVDs compliant with the In Vitro Diagnostic Regulation (IVDR) can be placed on the market until 30 June 2030.

Additionally, Class I medical devices and general IVDs under the MDD or IVDD, which did not require a notified body for conformity assessment, can only be placed on the Great Britain market if a notified body would be required under the EU MDR or IVDR.

But why has this happened and what does this mean for organisations with existing CE marked devices? 

Extended Market Access: Manufacturers will have more time to transition to the new UK regulations whilst still being able to sell CE-marked devices.

Planning and compliance: Currently, there is only draft text for Post Market Surveillance requirements (SI 2024), and there is no clear understanding of what the regulation will look like under UK legislation. This situation allows the UK to establish the necessary regulations in a timely manner while giving manufacturers time to transition as needed. This approach ensures that manufacturers can continue to supply the GB market with devices without causing a disruption in supply.

On 21st May, the Medicine and Healthcare Products Regulatory Agency (MHRA) published its 'Statement of policy intent: international recognition of medical devices”.  This policy is intended to allow medical device manufacturers to use device clearances in other regulatory jurisdictions to ease entry to the Great British market by recognising other international regulators' approvals.

Such recognition is intended to be available for devices with clearances in Australia, Canada, the EU, and the USA, with certain exceptions but has not yet been confirmed.

Most recently in November, the MHRA published a new consultation “Medical Devices Regulations: Route to market and in vitro diagnostic devices” for the GB market with the aim to seek views from stakeholder on the following four key areas until 5th January 2025:

  1. International Reliance: Medical devices and IVD’s can use the UKCA (UK Conformity Assessed) process to access the GB market either by self-certification for low-risk devices, or by conformity assessment and certification by an Approved Body.  There is future scope to enable the UKCA process to be complemented by the international reliance scheme to enable market access for devices already approved in comparable regulated countries.
  2. UKCA Marking: Remove the current requirements for devices which undergo the UK conformity assessment process to bear a UKCA Marking.
  3. In Vitro Diagnostic Devices (IVD): Updates to the classification to proportionately regulate IVD devices according to their risk.
  4. Assimilated EU Law: Remove the revocation date of four pieces of assimilated law to avoid disruptions. This proposal, alongside more specific transitional provisions – would ensure a smooth transition to a future regulatory framework, which aims to protect patient safety, improve access to innovative medical devices, and support innovation.

In summary, the MHRA’s consultation reflects GB’s intention to adopt international recognition in its medical device regulations. By seeking feedback from key stakeholders, the aim is to streamline market access for manufacturers, making the process quicker and more efficient. This approach not only supports the introduction of innovative technologies but also ensures that patients benefit from the latest advancements in medical devices.

On 9th May, the MHRA introduced the AI Airlock and regulatory sandbox for AI as a Medical Device (AIaMD). This pilot project aims to help the MHRA identify and address the challenges of regulating standalone AIaMD.

The regulatory sandbox model was established because AI technologies are difficult to test using traditional trial methods. The AI Airlock project’s collaborative approach is designed to identify and manage evidence requirements more effectively, to support areas such as data gathering and validation using real world data from within the NHS.

The insights gained from collaboration between the government, regulators, and industry will guide future AI Airlock projects and shape both UK and international AIaMD guidelines. The results of the pilot will be used to help develop forthcoming guidance and principles around proportionate regulation of AI within medical devices. This includes working with Approved Bodies on UKCA marking and partnering with trusted regulatory bodies for international recognition of medical devices.

European Union

The European Union (EU) is also considering the advancements of technology by adopting the AI Act 2024/1689 which is a legal framework specifically for Artificial Intelligence.  Although the AI act has not been created with medical devices in mind, there is a need to consider this with devices incorporating an AI aspect.  The key date for implementation is 2nd August 2027 for AI medical devices.

The AI Act focuses on several key areas to regulate artificial intelligence effectively:

  1. Risk-Based Approach: It categorises AI systems based on the level of risk they pose, ranging from minimal to high risk level, this ensures that higher-risk AI systems are subject to stricter requirements.
  2. Conformity Assessment and Certification: AI systems must undergo rigorous conformity assessments and obtain certifications to ensure they meet the required ethical and safety standards.
  3. Transparency and Accountability: It mandates that AI systems be transparent about their operations and decisions which includes providing clear information about how it works and any potential impacts. 
  4. Human Oversight: AI systems consider high risk must include mechanisms for human oversight to ensure they can be monitored and controlled by humans to prevent unintended consequences.
  5. Data Governance: It emphasises the importance of high-quality data for training AI systems.
  6. Enforcement and Penalties: It establishes enforcement mechanisms and penalties for non-compliance, ensuring that AI developers and deployers adhere to the regulations.

Regulation (EU) 2023/607 sets out the requirements of manufacturers to extend their certification under the MDD and AIMDD certification.  The extended transitional timeframes looked to assist notified body with ever struggling resource as well as the time and cost constraints to manufacturers.  Extended timeframes are as follows:

  • 31 December 2027 – Class III and IIb implantable devices excluding sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
  • 31 December 2028 – All other class IIb devices, class IIa device and Class I devices placed on the market in a sterile condition or having a measuring function.

The deadline for manufacturers to apply for the extension has now passed (24th May 2024) with the signed Notified Body agreement by 24th September 2024.  Any manufacturer who missed these deadlines or those who are bringing new devices to market will need to comply with the new regulations.

As a consultancy, one of the main questions we are commonly asked is the costs associated with Notified Body accreditation.  Earlier this year, the European Commission provided a useful list of Notified Bodies fee lists.  This should aid manufacturers to understand approx. costings to get through the certification process.

Conclusion

Throughout 2024, both markets have undergone numerous changes, with no signs of slowing down. These developments reflect the ongoing preparation for advancements in healthcare technologies, particularly in software and AI. They also emphasise the importance of staying current with the regulatory landscape to ensure compliance and foster innovation.