10 Checklist Items for the New UK Conformity Assessment.

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Author: Ed Ball
Date: Sept-Oct 2021
From: Medical Product Outsourcing(Vol. 19, Issue 7)
Publisher: Rodman Publishing
Document Type: Article
Length: 1,359 words
Lexile Measure: 1430L

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The transition to the U.K.'s new

regulatory regime officially began as of the first of January 2021. Medical device manufacturers are no newcomers to changing regulations, as they have been working toward EU MDR and IVDR compliance for quite some time. As they now turn their attention to the U.K., businesses will need to ensure all medical devices sold on the U.K. market are registered with the Medicines and Healthcare products Regulatory Agency (MHRA), including CE-marked and UKCA-marked devices. Although there are grace periods for this initial registration based on the risk classification of a device, it remains critical for manufacturers to act early to ensure their time to market is brief and they are not outpaced by the competition.

This new divergence between EU and U.K. requirements also means different rules apply to Great Britain (England, Scotland, and Wales) and Northern Ireland. During the transition period, the U.K. Medical Devices Regulations (U.K. MDR) 2002 will continue to apply in England, Scotland, and Wales, while CE marks will still be accepted up to June 30, 2023. In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply starting from 2021 and 2022 respectively, in line with the EU's implementation timeline.

While the detail of the U.K.'s future regulatory regime is yet to be determined, clearly understanding transition periods, areas of application, and overlap between EU MDR and IVDR preparation and the emerging U.K. framework is key to rapid, effective compliance. There are 10 key elements that manufacturers would do well to check-list to ensure they are always fully under their control.

Overlap of Requirements

Medical device businesses have already invested a great deal of time and resources in complying with new regulations and are no newcomers to the process of updating procedures and documentation. Their experiences planning for EU MDR and IVDR compliance are a valuable asset because some of their existing compliance efforts may be repurposed for UKCA marking. Establishing whether this is possible is a first step...

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Gale Document Number: GALE|A677878009