What dental devices are subject to the Medical DevicesDirective 93/42/EC (MDD) regulations?All custom-made devices are subject to the MDD regulations, theseare any device specifically made in accordance with a duly qualifiedmedical or dental practitioners written prescription with specific designcharacteristics and intended for the sole use of a particular patient,whether NHS, private or independent.Examples include:Appliances mainly constructed out side of the mouth on a model,including man-made temporary crowns, TMJ splints such asMitchigan and Tanner, Dentures/Crowns/Bridges, removableorthodontic appliances, etc.Cad-Cam although the dentist takes a digital image and it is fittedwhilst the patient is there, the machine makes the filling inlay/ onlay/crown/bridge etc. extra-orally and it is intended to last long-term.A denture constructed mainly outside of the mouth for someone whohas lost a tooth, including if only intended to last a week while a betteralternative is made.What dental devices are not subject to the MDD regulations?Normal dentistry that uses dental materials intra-orally.Examples include:Fillings, temporary fillings, temporary crowns, splinting teeth, etcA dental intra-oral filling, even if so large its an Onlay, made intraorallyA temporary Bridge made from acrylic intra-orally while a betteralternative was being constructedMass-produced devices which need to be adapted to meet thespecific requirements of the medical practitioner or any otherprofessional user are not considered to be custom-made devices.Etched orthodonticsRegistrants where the manufacture of dental appliances(for example fixed bridges, crowns, etc.) occurred mainlyoutside of the mouthWe manufacture custom-made Dentures, Crowns andBridges etc. in the dental practice, do we need to registerwith the Medicines and Healthcare products RegulatoryAgency (MHRA)?Yes. The MDD requires that manufactures of any dental device classedas a custom-made device must register with the MHRA, providingthem with a description of the devices concerned and the businessaddress.A registration form can be downloaded from the MHRA website:www.mhra.gov.ukSTANDARDS ON COMMISSIONING ANDMANUFACTURING DENTAL APPLIANCES FAQSwww.gdc-uk.orgGeneral Dental Council 37 Wimpole Street London W1G 8DQT +44 (0)845 222 4141 F +44 (0)20 7224 3294 E [email protected] W www.gdc-uk.orgI am constructing a removable orthodontic appliance in a dental practice, what do I need to do?Removable orthodontic appliances made for an individual patient are a custom-made device so firstly, youneed to ensure that the practice is registered with the MHRA. You also need to ensure that you fully complywith the requirements of the MDD as a manufacturer of a custom-made device this includes providing astatement of manufacture detailing all of the relevant pieces of information.Registrants providi
ng patients with a dental applianceAs the prescriber of a custom-made device, do I need to comply with the MDD regulations?Yes. As a GDC registrant you are responsible for finding out about laws and regulations which affect yourwork, premises, equipment and business, and following them. Also, Ann Keen (Parliamentary Under-Secretaryof the Department of Health at the time) has stated that the additional requirements of the MDD to ensurethat the patient is made aware that they can request the statement of manufacture and to ensure that it ismade available to the patient if it is requested are punishable as criminal offences if not complied with.How does the MDD affect me as the provider of a dental appliance directly to a patient?As the professional registrant providing the patient with a dental appliance you are responsible for ensuringthat they are offered a copy of the statement and providing them with this if they request it. You should recordwhether or not they choose to accept a copy of the statement, and if they do not you will need to keep thestatement for the lifetime of the appliance.Registrants who arrange for dental appliances to be made in the UKWho can make a dental appliance in the UK?Any GDC registrant that is suitably trained and competent to do so can construct a dental appliance so longas it is included as one of the skills or abilities that their registrant group should have, or could develop as anadditional skill, in the GDC Scope of Practice guidance booklet.If I am arranging for a dental appliance to be made in the UK, who can I ask to do this?If you arrange for a dental appliance to be made in the UK you are responsible for issuing the prescriptionto and receiving the appliance from a GDC registrant capable of making the appliance. If you do not do thisyou may face a GDC fitness to practice inquiry.Who does the manufacturer need to be registered with?All manufacturers of custom-made dental appliances must register with the MHRA, and provide them with adescription of the devices concerned and their business address. The list of registrants with the MHRA will bepublished on their website: www.mhra.gov.ukRegistrants who arrange for dental appliances to be made outside the UK by non-GDCregistered dental techniciansWhat extra responsibilities do I take on if I obtain a dental appliance made outside of the UKby non-GDC registered dental technicians?If you decide to prescribe or sub-contract the manufacture of a dental appliance outside of the UK and do notuse a GDC registrant, you will be held professionally accountable for the safety and quality of the appliance.This will include ensuring that the statement of manufacture, or if outside of the EU the name and address ofthe manufacturer are disclosed to the prescriber and patient.March 2011www.gdc-uk.orgSTANDARDS ON COMMISSIONING ANDMANUFACTURING DENTAL APPLIANCES FAQS