Vereinigtes Königreich - 11 - Medizintechnik
- 90 - Optische, fotografische oder kinematografische Instrumente, Apparate und Geräte; Mess-, Prüf- oder Präzisionsinstrumente, -apparate und -geräte; medizinische und chirurgische Instrumente, Apparate und Geräte; Teile und Zubehör für diese
General Medical Devices, Active Implantable Medical Devices and in vitro Diagnostic Medical Devices, which are defined under regulation 2 of The Medical Devices Regulations 2002. OPTICAL, PHOTOGRAPHIC, CINEMATOGRAPHIC, MEASURING, CHECKING, PRECISION, MEDICAL OR SURGICAL INSTRUMENTS AND APPARATUS; PARTS AND ACCESSORIES THEREOF (HS code(s): 90); Medical equipment (ICS code(s): 11.040); Dentistry (ICS code(s): 11.060); Hospital equipment (ICS code(s): 11.140); First aid (ICS code(s): 11.160); Birth control. Mechanical contraceptives (ICS code(s): 11.200)
The Medical Devices (Amendment) Regulations 2026; (102 page(s), in English)
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:
1. Introduction of an international reliance scheme providing swifter routes to market for certain medical devices and in vitro diagnostic (IVD) devices.
2. Classification changes to general medical devices and IVD devices for more risk-proportionate regulation.
3. Enhanced safety and performance requirements for medical devices and IVD devices, supporting closer alignment with international regulatory approaches.
4. More comprehensive technical documentation requirements, including enhanced retention periods.
5. Strengthened requirements for medical devices to claim equivalence to an existing device.
6. 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.
7. Regulation of misleading or unsubstantiated claims about medical devices and IVD devices.
8. Broadening the circumstances in which electronic instructions for use can be adopted in place of physical instructions.