MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority responsible for the MDR.
If you manufacture custom-made dental appliances such as fixed bridges, bleaching trays, crowns, splints, retainers, you are required by the Medical Devices Regulations (MDR) to register with the Medicines and Healthcare Products Regulatory Agency (MHRA), and provide your business address and a description of the devices you produce. Read more about how to register your custom-made dental devices on the mhra.gov.uk website
MEDICAL DEVICES REGULATIONS 2021
Watch the video to find out more about the new Medical Devices Regulations (MDR) and the steps you need to take to comply.
DTA members can download MDR support materials including a factsheet and statement template for MDR in the members area here: https://www.dta-uk.org/guidance-documents .
FOR DTA MEMBERS
The DTA provide members with regular updates, fact sheets, templates and guidance documents on the new MDR changes which you can view in the DTA Members area. Login now.
- Step-by-step video tutorial on how to add a custom-made medical device - Video Tutorial
- Quality Management - Standard Operating Procedures information sheet and template - Guidance Documents
- MDR Fact Sheet - Guidance Documents
- Template for the Manufactures Statement - Guidance Documents
- Medical Devices Regulations (MDR) - a heads up to 2020 Part 1 August 2018 - The Technologist Archive
- Medical Devices Regulations (MDR) - a heads up to 2020 Part 2 November 2018 - The Technologist Archive
- A new statement for custom-made dental devices (MDR 2020) May 2019 - The Technologist Archive
- Registering devices using GMDN codes - Guidance Documents
- MHRA Recent Communication and Guidelines 16 December 2020 - News Article
- MHRA Response to DTA 7 January 2021 - News Article