The DAMAS Specification Issue 8 has now been released and incorporates all the relevant updates to ensure DAMAS laboratories comply with the Medical Devices Regulation 2017.
Dental laboratories will be audited against the DAMAS Specification Issue 8 from 25th May 2020 and therefore all laboratories should ensure they have updated their DAMAS system by this date.
The laboratories DAMAS declaration of conformity should be updated using the example in Annex A of the DAMAS Specification to include the references of the new regulation.
Because dental laboratories manufacture custom made devices the person managing the 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. To comply with this requirement, dental laboratories will need to update their procedures folder with the name of the person that fulfils this requirement.
The requirement for approval for manufacture has been updated to require that a dental technician undertakes this process.
The requirement for documenting approved patient contact materials and suppliers has been updated to reflect that documentation shall be reviewed annually to ensure that the list details up to date information.
There is now a specific clause within DAMAS regarding traceability to ensure that purchased patient contact materials can be linked to an appropriate purchase order so that traceability of patient contact materials used in the manufacturer of custom-made dental appliances is maintained.
Achieving traceability can be achieved by maintaining a robust purchase order system (described in 4.4.3 and 4.4.4 of the DAMAS specification).
The laboratory cleaning procedure has been updated to include the requirement for the laboratory to have an infection control policy in place.
The procedure has been updated to reflect that records shall be retained for 10 years.
MDR statement requirements:
Additional labelling requirements:
Patient statements:
The new regulation now states 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’.
Post market clinical follow-up (PMCF) – to show compliance in achieving PMCF it is recommended to include a ‘Prescriber Feedback’ statement on the dental laboratory prescription.
Laboratory prescriptions/statements will need to be kept for at least 10 years.
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. The templates available from the DAMAS office will enable dental laboratories to review and collate information on items such as customer feedback, literature review and medical device alerts which will result in the production of a post market report. In addition, the dental laboratory shall produce a Periodic Safety Update Report, the templates available from the DAMAS office will enable dental laboratories to summarise the conclusions of the post market clinical follow up and risk management undertaken.
The new regulation introduces a requirement for the laboratory to establish, implement, document and maintain a risk management system.
Templates, which will be available from the DAMAS office, will enable dental laboratories to undertake a risk assessment of the manufacturing of their dental appliances and identify potential or actual issues throughout the manufacturing process. The template prioritises issues according to severity to enable dental laboratories to prioritise actions that prevent or reduce issues. Information relating to risk assessments undertaken will be reported in the laboratories post market surveillance reports.
Option 1 – Aimed at laboratories currently running the previously purchased DAMAS Implementation System.
DAMAS International has developed a ‘DAMAS Upgrade Pack’ to assist dental laboratories to implement the changes as easily as possible. This pack is designed using templates and checklists, following the same format as the previous full implementation system.
What does the pack consist of?
Costs and further information can be obtained via email at damasoffice@btinternet.com or by telephoning 0115 9648249
Option 2 – Aimed at laboratories that have previously developed their own DAMAS System or wish to implement their own procedures.
For dental laboratories looking to make their own changes to their DAMAS system, help can be obtained from the DAMAS office. You will be supplied with basic templates and guidance via email, which you can then use to integrate into your system using the guidance within the DAMAS Specification.
To obtain your free guidance email, please contact the DAMAS Office.
