05 February 2016
The MHRA is an executive agency of the Department of Health that, amongst other responsibilities, it is responsible for ensuring that medical devices in the UK meet the applicable standards of safety, quality and efficacy. The agency also regulates medicines, and blood components for transfusion
All “custom made devices” are subject to Medical Devices Directive (MDD) regulations, and that includes any device specifically made in accordance with a duly qualified medical or dental practitioner’s written prescription with specific design characteristics and intended for the sole use of a particular patient whether NHS or private.
The Medical Devices Directive requires that manufactures of any dental device classed as a “custom made device”, such as a Cerec restoration, must register with the MHRA, providing them with a description of the devices concerned and the business address.
A registration form can be downloaded from www.mhra.gov.uk
The General Dental Council requires each registrant to be responsible for finding out about laws and regulations which affect their work premises, equipment and business.
When producing Cerec restorations you must comply with the MDD regulations and as the prescriber of a “custom made device” it is important to ensure that the patient is made aware that they can request the statement of manufacture and to ensure that the document is made available to the patient if it is requested. Non-compliance with such an obligation is regarded as a criminal offence.