Drug Tariff Part IX information

The NHSBSA supports its staff to work in a hybrid home/office way. Part IX applications are most efficiently processed when they are submitted using email and we strongly encourage applicants to do this. Failure to do so may result in the application being delayed.

We are continually assessing and improving this way of working and your feedback will be considered for discussion with the Part IX Drug Tariff Forum.

Thank you for your understanding.

Extension to expiry dates of CE marked medical devices

Following notification from the MHRA of the extension to CE certificates following a new European Regulations (EU) 2017/745 and (EU) 2017/746, we will be accepting CE certificates which have expired. It remains the responsibility of the applicant to ensure they are meeting the transitional provisions for certain medical devices and in vitro diagnostic medical devices according to EU 2023/607, and the signature on the DT1A form will be indicative of this.

Further details can be found on the official website of the European Union.

Part IX documents and forms

Please make sure that you use the most recent DT1 application forms to apply to have a medical device listed in Part IX of the Drug Tariff. Failure to do so will result in the form(s) being returned and will delay processing.

Indicative schedule for Part IX Waves (PDF: 58KB)

Enhanced Assessment Framework (PDF: 432KB)

Part IX Application Guidance 2.0 (PDF: 707KB)

Part IX Policy Paper (PDF: 191KB)

Part IX guidance (Version 1.7) for manufacturers (PDF: 447KB)Part IX Frequently asked questions (PDF: 163KB)Summary of process and important notes (PDF: 137KB)DT1A application form (Word: 38KB)DT1B Class I non-sterile (Word: 18KB)DT1B Classes I (sterile), IIA, IIB, III (Word: 20KB)DT1B IV Diagnostics medical devices directive (Word: 24KB)DT1B Non CE or UKCA marked devices (custom made items or deodorants) EU or UKMDR (Word: 17KB)DT2 Declaration for continued listing (Word: 20KB)DT3 Change of product listing summary (Word: 26KB)DT3 Change of product listing (Excel: 19KB)