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MHRA MedTech Regulatory Reform Webinar: Briefing

By March 6, 2024No Comments

The MHRA yesterday outlined planned significant updates to UK Medical Device Regulations. The changes include updating the scope of the Regulations, changing the classification of in-vitro diagnostics devices (IVD) and change the Essential Requirements.

The definition of ‘in-vitro diagnostic devices’ will now include software and devices intended for diagnosing physical or mental impairments, predispositions to medical conditions or diseases, and predicting treatment responses or reactions. This closely mirrors the definition provided in the EU IVDR.

Changes to the classification of in-vitro diagnostic devices are expected to be seen in the upcoming future core regulations, due to be published in 2025.  The MHRA intends to align IVD classification with the IMDRF system. This is a broadly positive step, which adopts a risk-based approach and allows harmonisation with IVD classification internationally.

BIVDA have advocated for this position and are pleased to see this decision. However, BIVDA have some concerns around the proposed class C regulations, particularly where they significantly deviate from IMDRF/IVDR principles for cardio-vascular and neuro-degenerative diseases to form UK-only classifications. We will be engaging with the MHRA specifically on this point.

As set out in a 2021 IMDRF guidance document, devices will be categorised into four classes based on intended use. Of note, near-patient tests, companion diagnostics, software, AI diagnostics, and genetic tests will be included within the scope of the new UK regulations.

The Essential Requirements will be aligned to the General Safety and Performance Requirements (GSPRs) outlined in the EU IVDR. However, these requirements will be amended to suit the MHRA’s view of local needs while aligning with international best practice. These Essential Requirements will also be included in the upcoming future core regulations.

BIVDA will continue to work closely with the MHRA to ensure that members are kept fully informed of the introduction of these change. We will discuss these developments at our Regulatory Affairs Working Party on 22nd March and are keen to get to get members views to feedback to the MHRA. If you have any questions, or wish to provide early feedback, please contact us at regulatory@bivda.org.uk.

Ben Kemp