The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government body tasked with ensuring the safety and effectiveness of medical devices for patient use. Medical devices encompass a wide range of products and equipment designed for medical purposes, including diagnosing, preventing, monitoring, or treating diseases or injuries. Examples include pacemakers, artificial hips, blood glucose meters, pregnancy tests, medical decision support software, syringes, surgical instruments, and wheelchairs.
The MHRA is seeking input from the public (including patients, researchers, developers, manufacturers, suppliers, clinicians, and other healthcare professionals) on proposed changes to the regulatory framework to help achieve these objectives.
This consultation seeks feedback on proposed changes to the regulation of medical devices in Great Britain. It covers four main areas:
- International Reliance: Introducing an international reliance scheme to streamline market access for devices approved by comparable regulators abroad, complementing the existing UKCA (UK Conformity Assessed) process.
- UKCA Marking: Proposing updates to enhance device traceability and exploring the removal of current UKCA marking requirements for devices using this process.
- In Vitro Diagnostic (IVD) Devices: Classifying IVDs into four risk categories with tailored regulatory requirements for market access, based on their risk level.
- Assimilated EU Law: Proposing to retain specific EU-derived laws until a new regulatory framework is fully implemented, ensuring a smooth transition while maintaining patient safety and supporting innovation.
The consultation can be accessed using the following link
