Webinar: How Newly Released Regulatory Guidance by the UK MHRA Impacts Medtech | скачать в хорошем качестве

Webinar: How Newly Released Regulatory Guidance by the UK MHRA Impacts Medtech |

In this webinar, Priya Bhutani introduces the impact on the UK's regulatory framework, specifically focusing on recent MHRA guidelines. Reg Desk, a regulatory software platform, aims to streamline global compliance for medical device teams. Caroline Rosette, a regulatory expert with over a decade of experience in the medical device industry, discusses the guidelines issued by the MHRA following the UK's exit from the EU. Key points include: Transition Period: The UK is in a transition period that started on February 1, 2020, and ends on December 31, 2020. During this time, existing market access remains unchanged. New Guidelines Overview: The MHRA has issued guidance confirming that CE-marked products will continue to be recognized until June 30, 2023. However, from January 1, 2021, all medical devices and IVDs must be registered with the MHRA. Registration Requirements: Manufacturers based outside the UK must designate a UK Responsible Person for registration. Various grace periods for registration depend on device risk categories. Submission Process: A new online system will facilitate device registration, and approved bodies will conduct conformity assessments for UK requirements. Future Changes: Once the MDR comes into effect, the UK plans to transition to a new UKCA mark for compliance, while existing CE markings remain valid for a limited period. Clinical Data: While specifics on clinical data requirements for Class 3 devices are not yet defined, alignment with EU standards is expected. The session encourages attendee participation for questions and feedback, emphasizing the ongoing evolution of the regulatory landscape.