The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released updates to its guidance on medical device regulations, aiming to provide clarity for manufacturers, regulatory professionals, and healthcare providers.
Key Updates in the Guidance
- IVDR Transition Extension: The guidance includes information about the transitional extension for the EU’s in vitro diagnostic medical devices regulation (IVDR), ensuring manufacturers have clear instructions on compliance timelines and processes during the phased introduction.
- MDR Transition Guidance: Updates have also been made regarding the registration of medical devices within the scope of the EU’s medical device regulation (MDR) transition extension. Particular focus is placed on devices reliant on expired or expiring CE certificates and those newly upclassified under MDR.
- Reusable Class I Devices: New guidance addresses the registration of reusable Class I medical devices and surgical instruments, offering detailed directions for compliance with UK regulations.
Implementation Scenarios
To aid in practical application, the MHRA has outlined six scenarios illustrating the implementation of the updated guidance. These scenarios clarify how manufacturers should approach compliance for devices in various circumstances, such as reliance on extended CE certificates in Great Britain and Northern Ireland, expired certificates, and upclassified Class I devices.
Focus Areas in the Guidance
- Reliance on Extended Certificates: Detailed information has been provided on how extended certificates can support device registration in both Great Britain and Northern Ireland during the transition period.
- Management of Previously Expired Certificates: The guidance helps address concerns around devices with previously expired CE certificates, ensuring smooth continuity of supply and compliance.
- Certificates Expiring After March 20, 2023: The MHRA provides tailored instructions for medical devices whose certificates are expiring on or after March 20, 2023.
Implications for Stakeholders
These updates are aimed at streamlining regulatory processes and ensuring clarity for medical device manufacturers and regulatory professionals navigating the UK market. By incorporating practical guidance and scenarios, the MHRA seeks to reduce uncertainties surrounding transition periods and compliance requirements.
Manufacturers and regulatory teams are encouraged to review the revised document to ensure alignment with current UK regulations. For more detailed information, visit the MHRA’s official website.
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