Guidance Documents for Medical Devices

The guidance documents are designed to assist stakeholders in navigating the regulatory framework for medical devices. These documents provide comprehensive insights and practical instructions to ensure compliance with both local and EU standards.

What You’ll Find in the Guidance Documents:

• Step-by-step guidance for registration and listing of medical devices.
• Compliance requirements for Economic Operators and healthcare professionals.
• Instructions for reporting incidents and managing Field Safety Notices.
• Detailed explanations of relevant legislation and regulatory procedures.
• Best practices for maintaining safety and quality standards throughout the medical device lifecycle.

Stay Informed and Compliant
Our guidance documents are essential resources for anyone involved in the development, importation, distribution, or monitoring of medical devices.

For further assistance, please contact the Medical Device and Pharmaceutical Collaboration Directorate at devices.medicinesauthority@gov.mt.

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-MDF18 Guidance for Application for Customs Documentation and Product Compliance Evaluation: <Link>

GL-MDF19 Guidance for Application Forms for a Derogation from the Conformity Assessment Procedures of Medical Devices: <Link>

GL-MDF20 Guidance for Request for Advice on making available Medical Device/In-Vitro Diagnostic in Malta: <Link>

GL-MDF21 Guidance for Application for Medical Device/In-Vitro Diagnostic Evaluation of Risk Classification: <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>

European Commission Fact Sheets

https://ec.europa.eu/health/md_newregulations/publications_en

European Commission Guidelines

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en