PDSE Dental Laboratory

The aim of this tender is to ensure that PDSE achieves value for money, the highest quality work and consistent service level, by competitively offering these services to the market.

Peninsula Dental Social Enterprise CIC (PDSE) was founded in 2013 and is responsible for running four Dental Education Facilities across the Southwest, with clinics in Exeter, Truro and two in Plymouth.

PDSE also employs its own team of in house clinicians who treat a range of patients including specific initiatives such as a dedicated clinic for people experiencing homelessness in Plymouth.

Students are on site for approximately 38 weeks per year and the number of clinical days undertaken by each student year group increases as they progress through the course. Currently, years 1, 2 and 5 are based in Plymouth with years 3 in Exeter and 4 in Truro although this is under review.

PDSE does have its own in house laboratory in both its Truro and Devonport facilities. This is a basic set up, currently used for teaching to supporting the student's curriculum only, and not to produce work for patients.

All bidders must have and be able to provide evidence of accreditation with DAMAS, GDC registration and MDR (MHRA) laboratory registration number

If you make a dental appliance, you must understand and comply with your legal responsibilities as "manufacturer" under the Medical Device Regulations (MDR). This includes the legal requirement to register with the Medicines and Healthcare products Regulatory Agency (MHRA).

From 26 May 2020 the current Medical Devices Directive (MDD) will change to become the Medical Device Regulations (MDR). If you commission and manufacture dental appliances you must comply with the Medical Device Regulations (MDR). Compliance with this is a legal requirement and failure to comply is a criminal offence (gdc-uk.org)

All materials used in the manufacture of appliances must meet the essential requirements of the MDR/MHRA/ISO.

You must ensure that all DAMAS Management System Specifications and MDR requirements are met including all quality, pricing, labeling and cross infection, and when commissioning appliances, a statement of manufacture must be offered to the patient.

The contractor is responsible for ensuring all elements of the process have undergone the appropriate disinfection processes and protocols.

Please find all documents in relation to this tender on Intend - https://in-tendhost.co.uk/plymouthuni