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Home / Medical Devices / Medical Devices Guidance

Medical Devices Guidance

Please find below the list of guidance documents.

 

GL-MDF01 Guidance for Application for Certificates of Free Sale for Medical Devices: <Link>

GL-MDF02 Guidance for Application for Organisation Registration in relation to Medical Devices: <Link>

GL-MDF03 Guidance for Application for Medical Devices Registration to place Medical Devices on the EU Market: <Link>

GL-MDF04 Guidance for Request Form for the Use of a Non-CE Marked Medical Device in Malta on a Named-Patient Basis: <Link>

GL-MDF05 Guidance for Application for Notification of Medical Devices Made Available on the Local Market: <Link>

GL-MDF06 Guidance for Application for Designation of a Notified Body for Medical Devices: <Link>

GL-MDF07 Guidance on Fees in relation to Medical Devices: <Link>

GL-MDF08  Guidance for the Medical Devices Incident Report Form – Healthcare Professionals: <Link>

GL-MDF09 Guidance for the Medical Devices Incident Report Form – General Public: <Link>

GL-MDF10 Guidance for Notification of Point-of-Care Covid-19 Test or Device for Self-Testing for Covid-19: <Link>

GL-MDF11 Guidance for Application for Designated Premises to be approved for the performing of Point-of-Care Covid-19 Tests: <Link>

GL-MDF13 Guidance for Application/Notification for Clinical Investigations under Regulation (EU) 2017/745 on Medical Devices: <Link>

GL-MDF14 Guidance for Application/Notification for Performance Studies under Regulation (EU) 2017/746 on In-vitro Diagnostics: <Link>

GL-MDF15 Guidance for Notification for Modification of Clinical Investigations under the Regulation (EU) 2017/745: <Link>

GL-MDF16 Guidance for Notification for Modification of Performance Studies under the Regulation (EU) 2017/746: <Link>

GL-MDF17 Guidance for Application for Pre-submission Meeting Request for Clinical Investigations/Performance Studies: <Link>

 

GL-MDC01 Guidance on Reporting of Adverse Events in Clinical Investigations and Performance Studies: <Link>

 

GL-MDS01 Guidance on Good Distribution Practice in relation to Medical Devices: <Link>