The MHRA (Medicines and Healthcare products Regulatory Agency) recently hosted a Medical Devices Webinar; designed to provide an overview of product conformance and the UK medical devices regulatory system, including the MHRA’s Medical Devices Regulation and the role of Notified Bodies.

It also provided an update on recent changes to the Medical Devices Regulation, including the latest on the European Medical Device Regulation (MDR), an update on the latest changes, and their impact on manufacturers.

The webinar informed stakeholder groups on topics such as the classification, evaluation, and conformity assessment of medical devices, including an overview of the UK’s Medical Device Directive (MDD).

The MHRA highlighted patient safety and benefit, “need for patient safety and being supportive in an operating environment to support industry and patients.”  During the Q&A, it was added that the MHRA is also exploring countries that form part of the IMDRF and that as part of this initiative, the MHRA is conducting gap analysis of other legislation with “patient safety at the heart of what we do,” and that the regulator “may do different things with different classifications.”

Attending on behalf of Woodley BioReg, Principal Consultant Dr Ash Ramzan commented: “Whilst the updates were not necessarily new, the webinar provided the opportunity for MHRA to outline timelines of regulation development and transitional arrangements, following the announcement to extend the current standstill period by 12 months.

“As market leaders on the regulatory process and developing regulatory guidance, the timelines affect the work that stakeholders are doing and through questioning the UK’s medical device regulatory system, it raised the importance of pre-market assessments, and the need for post-market surveillance as key elements of the MHRA’s future regulatory provisions for medical devices and diagnostics.”

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