Medical Devices Guidance

Please find below the list of guidance documents.

 

GL-MDF01 v3 Guidance for Application for Certificates of Free Sale for Medical Devices: <Link>

GL-MDF02 v3 Guidance for Application for Organisation Registration in relation to Medical Devices: <Link>

GL-MDF03 v3 Guidance for Application for Medical Devices Registration to place Medical Devices on the EU Market: <Link>

GL-MDF06 v3 Guidance for Application for Designation of a Notified Body for Medical Devices: <Link>

GL-MDF07 v6 Guidance on Fees in relation to Medical Devices: <Link>

GL-MDF08 v3  Guidance for the Medical Devices Incident Report Form – Healthcare Professionals: <Link>

GL-MDF09 v3 Guidance for the Medical Devices Incident Report Form – General Public: <Link>

GL-MDF10 v1 Guidance for Notification of Point-of-Care Covid-19 Test or Device for Self-Testing for Covid-19: <Link>

GL-MDF11 v1 Guidance for Application for Designated Premises to be approved for the performing of Point-of-Care Covid-19 Tests: <Link>

 

 

GL-MDS01 v1 Guidance on Good Distribution Practice in relation to Medical Devices: <Link>

 

Fact Sheet for Manufacturers: <Link>

Fact Sheet for Authorised Representatives: <Link>

Fact Sheet for Importers and Distributors: <Link>