On the 9th of January, the MHRA in the UK published an updated roadmap to regulation of medical devices in the UK.
Click here to view the document.
Key Highlights:
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- Future core regulations discussions with stakeholders in first half of 2024 for classification, essential requirements, approved bodies, exempt devices, clinical investigations, obligations of economic operators, QMS, conformity assessments, qualified persons.
- Second half of 2024 stakeholder discussions on UDI, implantable devices, and transition arrangements.
- Second half of 2024 SaMD guidance to be published.
- IVD roadmap to be published in Q1 (or first half of) 2024.
- IVDR-Northern Ireland regulations to be in force in Q1/Q2 2024.
- PMS regulations to go before Parliament mid-end Q2 2024 (end of first half of 2024).
If you’d prefer to read about MHRA’s plans rather than use the infographic, please click here.
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