Medical Equipment: Registration
The question
To ask the Secretary of State for Health and Social Care, what steps the MHRA is taking to address circumstances in which a previously used GMDN Level 2 code has been obsoleted or materially amended at the point of mandatory device registration renewal.
Answered by Dr Zubir Ahmed
Global Medical Device Nomenclature (GMDN) Codes and Categories are managed by the GMDN Agency. The GMDN Agency may obsolete GMDN Codes within a hierarchy of GMDN Categories. If a GMDN Code is obsoleted, the Medicine and Healthcare products Regulatory Agency (MHRA) will receive a feed notifying it of the GMDN Code obsolescence. When a GMDN Code becomes obsolete, the MHRA notifies all registrants that are impacted by the obsolescence. Applicants are notified within the MHRA Device Online Registration System (DORS). The applicant can then update the obsolete GMDN Code to an active GMDN Code within DORS.
If a newly selected active GMDN Code falls within a different GMDN Level 2 Category, or Level 1 Category where no Level 2 Category exists, an annual fee may become payable from 1 April of the following year at the time of renewal. The fee will be charged if the newly selected GMDN Code is the only device within the chargeable category.
Verbatim has judged this answer against the question that was actually asked — answered, partly answered, or evaded. Sign in to see the verdict →