The New Regulatory Framework - UK

The MHRA previously confirmed that it would use expertise and decision-making from comparable regulator countries (CRC), (CRC countries are the EU, US, Australia, and Canada), to bring medical devices to the UK market. Within the system of recognition and trust, the so-called Reliance Route for Market Authorization (MA) framework, the MHRA retains the right to reject applications if necessary.

The new regulatory UK framework will enable faster market access in the UK for medical devices already approved by the CRCs. This MA framework also applies to medical devices with an MDSAP (Medical Device Single Audit Program) certificate. A potential issue is how to integrate 510K approved devices, as there is a degree of trust dependency on issued declarations of conformity.

Post-market surveillance (PMS) for medical devices remains a vital building block anchored in the new UK Regulations expected to be published in mid-November-December 2024. Implementing a “PMS Safety Net”, as part of the UK Regulatory Framework will be a priority. An important assumption is that medical device safety will be improved by the legal obligation for healthcare providers to report device issues.

The focus of the MHRA on PMS differs from that of the EU because the UK has the ambition to become an incubator of global innovation. The MHRA will continue to review the PMS requirements for CRC-approved devices and those with MDSAP approval under its regulatory reliance plan to ensure they remain fit for purpose and maintain safety.

As said, post-market surveillance (PMS) is critical to the UK’s medical device regulatory framework. Manufacturers must

  • prioritize establishing a comprehensive PMS system,
  • developing clear and organized PMS plans, and
  • promptly reporting incidents and corrective actions.

Adhering to these regulations ensures their medical devices’ ongoing safety and reliability throughout their lifecycle, contributing to a safer healthcare system for patients and healthcare professionals. These regulatory changes aim to strengthen oversight for medical devices and in-vitro diagnostic devices in the UK, emphasizing improved post-market surveillance and vigilance to safeguard public health and enhance patient safety.

Some differences in the PMS between the EU and the UK are:

  • The EU emphasizes the pre-market phase more than the post-market phase. UK Regulations emphasize the post-market phase.
  • The UK regulation will use a broader definition for “preventive action”. “Potential failures” would be included within the definitions of “incident” and “serious incident”, implying serious deterioration of health classifications, such as
    • “hospitalization/prolongation”,
    • “medical treatment”,
    • “chronic illness”, and
    • “fetal distress/death”.
  • The UK regulation requirements are different for:
    • investigating and reporting serious incidents;
    • preparing post-market surveillance reports, field safety corrective actions, and field safety notices;
    • trend reporting; and
    • retaining PMS documentation.

Highlights for Medical Device PMS

  1. Clarified PMS Period: 

The PMS period starts from the day the first device of a model is put into service or placed on the market and ends with the last device’s end of life for that model. During this period, manufacturers must fulfill all PMS obligations, including creating a comprehensive PMS plan and submitting PSURs (Periodic Safety Update Reports) based on risk class.

  1. MORE Portal Enhancements: 

The MHRA is enhancing the MORE portal, which is dedicated to adverse incidents and vigilance reporting, to ensure better user experience and reporting efficiency.

  1. Post-Market Surveillance System: 

The UK mandates establishing a PMS system for each medical device proportionate to its associated risks. The system should continuously analyze quality, performance, and safety data throughout the device’s lifespan.

  1. Post-Market Surveillance Plan: 

The PMS plan forms the basis of the PMS system and must be clear, organized, and searchable. It outlines processes for data collection, analysis, and interactions with relevant parties.

  1. Preventive and Corrective Actions: 

Manufacturers must immediately reduce risks or non-conformities that compromise a device’s safety or performance. Notifications about field safety corrective actions are required.

  1. Reporting Serious Incidents: 

Manufacturers must promptly report serious incidents involving their devices to the Secretary of State, including detailed information about the incident and any preventive or corrective actions.

  1. Field Safety Corrective Actions and Notices: 

Manufacturers must conduct a risk assessment and notify the Secretary of State before implementing any field safety corrective actions. A Field Safety Notice must accompany the action.

  1. Post-Market Surveillance and Periodic Safety Reports: 

Manufacturers are required to produce Post-Market Surveillance Reports (PMSRs) or Periodic Safety Update Reports (PSURs) for certain devices, summarizing surveillance data and actions taken.

  1. Trend Reporting: 

Significant increases in the frequency or severity of incidents must be reported to the Secretary of State to investigate potential safety issues.

IDAP

The Innovative Devices Access Pathway (IDAP) pilot is an initiative to bring new medical technologies to the UK to help with medical needs that are currently unmet.

IDAP aims to enable and improve patient access to innovative and transformative medical devices by providing developers with an integrated and enhanced regulatory and access pathway.

Contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.

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