The new Medical Device Regulation will come into force after a three-year transition period ending on May 25th 2020; all dental laboratories should be fully compliant by this date.
The main changes to the MDD include:
Changes to the laboratory prescription/statement:
- The dental laboratory must declare the name and address of the manufacturer, and of all manufacturing sites.
- Slight changes in statement of conformity wording (the term ‘essential requirements’ is being replaced by ‘general safety and performance requirements’).
- The requirement for detailing the patients name will change so that the patient can also be identified by an acronym or a numerical code.
- For the patient statement, the new regulation declares that the statement ‘shall’ be made available to the patient. This has tightened up the previous requirement and removed the term ‘made available to the patient on request’.
- Laboratory prescriptions/statements will need to be kept for at least 10 years. The previous requirement was 5 years.
Post Market Clinical Follow up:
This will enhance the already existing documentation within the laboratory for recording complaints and remakes. The dental laboratory will need to have a plan detailing how they will proactively collect and evaluate clinical data which confirms the safety and performance of their devices. It is envisaged that this would be a simple system which will see the lab review and collate information on items such as customer feedback, literature review and medical device alerts, which will result in the production of a simple post market report. In addition, the dental laboratory shall produce a Periodic Safety Update Report at least every two years, which will summarise the conclusions of the post market clinical follow up undertaken.
Person Responsible:
The new regulation will require a specific person within the laboratory to be responsible for compliance. Because dental laboratories manufacture custom made devices, the person looking after your MDD/DAMAS system will need to have either a qualification in the relevant discipline or at least 2 years’ experience in the relevant field of manufacturer.
Risk Assessment:
The new regulation introduces a requirement for the laboratory to establish, implement, document and maintain a risk management system. The purpose of running a simple risk management system is to ensure that the devices that the dental laboratory is placing on the market are safe for the patient.
More information, including a guidance booklet and various templates, is available to DLA members free of charge on the DLA website in the Members Area. If you have any questions please contact the DLA office on info@dla.org.uk