MHRA MDR

Once logged in, just click on guidance documents and you will find a useful summary of information generated by DTA to assist in your understanding of the implementation of the MDR as required by MHRA. Please note, it is a legal requirement for dental laboratories who are manufacturers of custom-made dental devices to be registered with MHRA and follow the MDR regulation.

DTA's MDR RESOURCES

The DTA provides members with regular updates, fact sheets, templates and guidance documents on the new MDR changes that you can view in the DTA Members' area.

• Quality Management - Standard Operating Procedures information sheet and template - within Guidance Documents 
• MDR Fact Sheet - within Guidance Documents 
• Template for the Manufacturer's Statement - within Guidance Documents  
• Medical Devices Regulations (MDR) - a heads-up to 2020, Part 1, August 2018 - within The Technologist archive 
• MDR - a heads-up to 2020, Part 2, November 2018 - within The Technologist archive 
• A new statement for custom-made dental devices (MDR 2020) May 2019 - within The Technologist archive 
• Registering devices using GMDN codes - within Guidance Documents 
• MHRA Recent Communication and Guidelines, 16 December 2020 - News Article 
• MHRA Response to DTA, 7 January 2021 - News Article 

MHRA RESOURCES

The government website has a step-by-step video tutorial  for registering a custom-made device.