May 16th, 2016
Many dental laboratory owners will remember the changes to the Medical Devices Directive that came into force in March 2010 which included changes such as the patient statement and a legal requirement to record complaints. But were you aware that as part of these changes the registration details of manufacturers including dental laboratories changed from being confidential to that of a public register.
Prior to 2010 all manufacturers that were registered with the MHRA were written to and informed that information held by the MHRA would no longer be confidential and as part of the process of releasing this information on a public register manufacturers had to confirm their registration details.
The letter sent out by the MHRA required that all dental laboratories confirm their registration information was correct and that continued registration was required by the laboratory. This confirmation by the dental laboratory was required in writing. Essentially if no confirmation was received from the dental laboratory manufacturer by the MHRA prior to the deadline in 2009 then the MHRA archived the laboratory registration and considered the laboratory to be no longer registered.
If you had moved business premises since your first registration with the MHRA which was previously named the Medical Devices Agency (MDA) and you didn’t inform the MHRA you would not have received this letter and you may not now be registered.
It is essential that all manufacturers verify their registration to ensure that the dental laboratory is registered and that the registration details are correct and up to date.
To check if your dental laboratory registration is current visit the following link which will take you directly to the register for dental appliances, alternatively you may visit the MHRA website and undertake a general search using the following wording ‘Access to the Medical Devices Register’:
If your dental laboratory information is incorrect or out of date then you will need to rectify this by accessing the MHRA’s Devices Online Registration System (DORS). This online registration system can be accessed at https://aic.mhra.gov.uk/era/drsystem.nsf/login . Once your account is activated by the MHRA you will be able to make the necessary changes. Please note that for new and subsequent changes to the registered details held by the MHRA, the statutory fee of £70.00 will be charged.
If you need help with any aspect of MHRA registration contact the DLA office on 0115 9254888
Categories: Dental Laboratory News