Do all businesses who manufacture dental appliances need to register with the Medicines and Health Care Regulator for MDD from the start of business?
The MHRA (web link – http://www.mhra.gov.uk/Aboutus/index.htm ) is the regulatory body who maintain the record of all those businesses who are required to register under the Medical Devices Directive (MDD) and this includes all dental laboratories. The MHRA are in the process of providing public access to the register such that the public can check that a business or sole trader who is carrying out such activities as making dental appliances, are on the register and therefore maintaining accurate manufacturing details. CUSTOM-MADE DEVICE means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient, whether NHS, private or independent.
