The latest MHRA update outlines significant regulatory reforms in the medical device industry, with the goal of enhancing patient safety and aligning with global standards.
Post-Market Surveillance
A new regulation for establishing clearer guidelines for the monitoring and reporting of medical devices post-market will be brought before Parliament before the end of the year.
Pre-Market Statutory Instrument (SI)
The next pre-market SI will introduce a number of initiatives aimed at improving patient safety. These include:
Higher Classification and Scrutiny – Certain medical devices will be categorized as having a higher risk, which means that they will need to undergo a more thorough evaluation before they can be marketed.
Unique Device Identifiers (UDIs) – A legal requirement for UDIs will improve device traceability throughout the supply chain.
Implant Cards – Manufacturers of implantable medical devices are required to provide patients with a card that contains details about the implanted device. This empowers patients to give informed consent and enables them to respond effectively to safety alerts.
Regulatory Claims – New regulations will be implemented to ensure that manufacturers’ claims about their devices align with approved uses.
Patient Access
The forthcoming statutory instrument will streamline product approvals in the UK by taking into account rulings from similar regulators in order to improve patient access. Additionally, products that have received EU approval can be sold in Great Britain until at least 2028, and in some cases, even until 2030.
Global Regulatory Alignment
The UK is working to align its regulatory framework with international standards through collaboration with the International Medical Device Regulators Forum (IMDRF). This initiative aims to expedite product approvals for devices that meet trusted standards from reputable regulatory bodies and reduce duplication in regulatory processes.
Regulation of In Vitro Diagnostic Devices (IVDs)
In vitro diagnostic devices (IVDs) must be regulated proportionately in order to facilitate prompt interventions that may delay or eliminate the need for treatment. The organization plans to consult on a proposal to amend IVD regulations by adopting the IMDRF’s A-D classification system based on product risk in order to guide the Pre-Market SI. As long as they maintain a certified Quality Management System, most class B devices can self-assess their compliance with regulations thanks to this risk-based approach that tailors regulatory requirements for each class.
Software Regulations
The organization is putting into practice a stricter classification policy for software, which involves defining software terms more precisely and scrutinizing software – including artificial intelligence – more closely. Predetermined change control strategies for these software products will also be introduced to guarantee that regulations stay responsive to the rapid advancements in technology. This strategy seeks to strike a balance between efficacy and safety with the dynamic nature of digital technology.
UKCA Marking
In light of UDI implementation, the consultation will look at the possibility of more flexible UKCA marking rules for manufacturers. These changes aim to improve patient safety while maintaining a streamlined and effective system of access to safe medical products.
