إجراء مقترح من المملكة المتحدة: أدوات وأجهزة للبصريات أو للتصوير الفوتوغرافي أو السينمائي…

The measures will amend the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) as applicable in Great Britain (GB). The amendments seek to update the pre-market requirements that manufacturers must meet before placing their devices on the GB market. This will help improve patient safety, enable swifter access to medical devices through streamlined, risk-based regulatory pathways and international reliance routes, and support innovation by modernising the Regulations, aligning them more closely with international best practice. Key changes include: Introduction of an international reliance scheme providing swifter routes to market for certain medical devices and in vitro diagnostic (IVD) devices. Classification changes to general medical devices and IVD devices for more risk-proportionate regulation. Enhanced safety and performance requirements for medical devices and IVD devices, supporting closer alignment with international regulatory approaches. More comprehensive technical documentation requirements, including enhanced retention periods. Strengthened requirements for medical devices to claim equivalence to an existing device. Requirement for mandatory use of Unique Device Identifiers for medical devices and IVD devices along with implant cards for implantable medical devices, improving traceability, ability to manage adverse events, and transparency for patients. Regulation of misleading or unsubstantiated claims about medical devices and IVD devices…