E-Forms

Please find below the list of e-forms related to Medical Devices.

MT-MDF01 Application for Certificates of Free Sale for Medical Devices - <Link>

MT-MDF02 Application for Organisation Registration in relation to Medical Devices - <Link>

MT-MDF03 Application for Medical Device Registration - <Link>

MT-MDF04 Request Form for the Use of a Non-CE Marked - <Link>

MT-MDF05 Application Form for Notification of Medical Devices Made Available on the Local Market - <Link>

MT-MDF06 Application for Designation of a Notified Body for Medical Devices - <Link>

MT-MDF07 Application for Designated Premises for COVID-19 - <Link>

MT-MDF10 Application for Notification of Point-of-Care Covid-19 Test or Device for Self-Testing for Covid-19 - <Link>

MT-MDF11 Application for Medical Device Registered Person (MDRP) - <Link>

MT-MDF12 Derogation Application MDR Article 59 and IVDR Article 54 - <Link>

MT-MDF13 Derogation Application MDR Article 97 and IVDR Article 92 - <Link>

MT-MDF14 Application for pre-submission meeting request for clinical investgations or performance studies - <Link>

MT-MDF15 Clinical Investigation – Application or Notification form under the Medical Device Regulation - <Link>

MT-MDF16 Performance Study– Application or Notification form under the In Vitro Diagnostic Regulation - <Link>

MT-MDF17 Notification for Modification of Clinical Investigation under the MDR - <Link>

MT-MDF18 Notification for Modification of Performance Study under the IVDR - <Link>

MT-MDF19 Request form for Medical Device-IVD advice- <Link> 

MT-MDF20 Request form for Medical Device-IVD classification confirmation - <Link>

MT-MDF22 Application for Customs Documentation and Product Compliance Evaluation - <Link>

Incident Report Forms

Health Care Professional Incident Report Form - <Link>

Public Incident Report Form - <Link>

Templates to be Uploaded on e-forms

Excel Sheet for Application MT-MDF01 - Certificate for Free Sale - <Link>

Excel Sheet for Application MT-MDF03 - Medical Device Registration - <Link>

Excel Sheet for Application MT-MDF05 - Medical Device Notification - <Link>

Excel Sheet for Application MT-MDF22 - Customs Evaluation - <Link>

Declaration Form

A declaration form should be attached to the e-form and submitted online for each e-form.

The declaration form can be found <here>.

Guidance documents on medical devices can be found through the following <link>

All forms should be submitted to mdforms.medicinesauthority@gov.mt