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What you need to know about the MHRA consultation on medical device regulation

Date: August 31, 2021

Category: Industry news


The MHRA call for feedback and input from healthcare stakeholders on the future of medical device regulations and UDI in Great Britain.

Background

Now that The Medicines and Medical Devices Act has become legislation the Medicines and Healthcare products Regulatory Agency (MHRA) will issue new regulations as to the requirements of the future of unique device identification and identification of medical device actors in Great Britain (GB). One of the regulations for the MHRA will be to register medical devices to create a database of devices on the GB (England, Scotland and Wales) market.

Timelines for the regulation to register medical devices are as follows:

  • Class III 1 May 2021
  • Class IIa and IIb 1 Sept 2021
  • Class I 1 January 2022  

The registration will ensure a unique device identifier (UDI) for each medical device and the MHRA are currently reviewing options for the identification of license holders.

Call to action

The MHRA will soon be releasing a public consultation (mid-September) addressing the future of UDI regulation in Great Britain. The consultation will call for the opinions of medical device manufacturers, wholesalers, distributors, suppliers, healthcare provider organisations, and solution providers, to share input.

For the fundamentals of UDI to work efficiently, there needs to be no ambiguity as to what the product’s primary identifier is. A sole, globally unique identifier should be used on the designated device – one barcode encompassing all the necessary product information i.e. batch/lot number and expiry date.

Organisations (in this case those listed above) should also be accurately identified by a single means that is universally recognised – a standard, unique Actor ID. This will improve the traceability of products to ensure compliance with regulation as a critical patient safety measure.

What you need to do

This is a unique opportunity for all healthcare stakeholders to help shape the future of UDI regulation in GB.

Here are the two easy steps you need to follow to do so:

  1. One nominated respondent needs to be allocated from your organisation to address the public consultation
     
  2. Present your recommendations/suggestions regarding the use of a single, globally unique identifier for medical devices. One barcode only, standardised across all device packaging to prevent confusion or identification errors.

“Since parallel processes lead to unnecessary expenditure of time—and the benefits speak for themselves – the hospital’s message to its suppliers is unmistakable.

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