Quality and regulatory

At a glance

Class Imedical device
Since 2002supplying UK social care, the NHS and families
TEC Qualitycertified supplier of technology enabled care
CE and UKCAmarked devices

Medical device regulation

Pivotell automatic pill dispensers are CE and UKCA marked, and registered as Class I medical devices with the MHRA in the UK and on EUDAMED, the European database for medical devices. They meet the requirements of the UK and EU Class I medical device regulations, and declarations of conformity are available on request.

Where our products are made

  • All Pivotell automatic pill dispensers and spare trays are made in Sweden
  • The Pivotell Tipper is made in England

Testing and compliance

Pivotell dispenser plastics incorporate a premium silver ion technology that is introduced during the manufacturing stage to help protect against bacteria on the surface of the dispenser. The devices are now easier to keep hygienically clean for the patients, their family and visiting carers, plus pharmacists and their staff, who are all regularly handling the device.

The plastics are tested to ISO 22196, which measures antibacterial activity on plastic surfaces. View the test report or read more about the antibacterial protection.

Connected products and your data

The Advance GSM and our connected models send alerts through an online Administration Centre. Personal data is handled in line with UK GDPR. See our privacy policy.

Industry standards

TEC Quality Certified OrganisationUKAS accredited certification

TEC Quality Standards Framework (QSF)

Certified to the QSF, the UKAS-accredited quality scheme for technology enabled care, since August 2022.

Patents

The Pivotell/Careousel dispenser design holds patent nos EP2642966 / SE 535 462 C2 / US 9,027,787 B2.

Documents available on request

  • Declarations of conformity
  • Instructions for use
  • Test certificates
  • TEC Quality (QSF) certificate
  • Product specifications and data sheets
Eligible for VAT relief. Pivotell products can be bought without VAT by people who are chronically sick or disabled. Find out more.

Design heritage: the original Pivotell dispenser design won the Excellent Swedish Design award in 1997.

Request documents

This is the basket Message

This is the basket Message