Custom-made devices and the new Medical Devices Regulations (MDR). Are you ready for May 2020?
What is a custom-made device?
A custom-made device is manufactured specifically in accordance with a written prescription of a registered medical practitioner and is intended for the sole use of a particular patient.
All manufacturers of custom-made dental appliances 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.
- Meet the particular requirements of the MDR, which relate to custom-made devices.
Implementing the MDR
The original framework for medical devices, which consisted of the Medical Devices Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC, has now been consolidated and updated. These directives are now combined under the MDR.
The new MDR will be fully implemented by 26 May 2020. During the transition period, devices can be placed on the market under the current EU Directives, or the new Regulations (if they fully comply). However, devices placed on the market after the transition period will need to fully comply with the MDR, unless the manufacturer wishes to make use of the extended period of CE (certification mark) certificate validity.
One of the main changes coming into effect from May 2020, is the legal requirement to offer patients a copy of the ‘Statement of Manufacture’ produced by the manufacturer. The Dental Technologist Association (DTA) offers a template for a Statement of Manufacture which can be downloaded here.
To find out if you are you up to date with the new MDR changes watch the DTA video , which provides an overview of the requirements and clarifies the changes and steps that need to be taken to comply.
What about a no-deal Brexit?
In the event of a no-deal Brexit, the MHRA would take on the responsibilities for the UK market currently undertaken through the EU system. More information on regulating medical devices in the event of a no-deal Brexit can be found on the UK government website. The following tool might also be of assistance, Brexit: check what you need to do if there is no deal.
To find out more
You can find further information or contact others for support at:
The UK government website offers further useful guidance on how to comply with the legal requirements of MDR.
- If you have any queries on the new Regulations you can email MHRA directly at [email protected].
- You can download a form to register with MHRA on their website mhra.gov.uk.
- If you would like to hear more about how the DTA support dental technologist visit our website dta-uk.org or you can get in touch with us by phone 01242 461931 or email [email protected].