Regulation of Medical Devices and IVDs in Malta


In Malta, medical devices are regulated by the Malta Medicines Authority (MMA), having replaced the Malta Competition and Consumer Affairs Authority (MCCAA) as the local EU Competent Authority in 2020. Although the EU Medical Device Regulation 2017/745 (MDR) and EU In Vitro Diagnostic medical device Regulation 2017/746 (IVDR) both apply to Malta (as an EU Member State), medical devices are regulated through the Medicines Act (CAP 458).

Subsidiary Legislation 458.59 [August 2020], titled ‘Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations’, builds on CAP 458 and lays down some additional local requirements. The legislation states that “No person shall carry out importation, wholesaling, manufacturing or re-purposing in Malta of any medical device which is intended for trade within the European Union and, or the local market prior to obtaining all the necessary approvals, authorisations, licences, permits and, or any notification/s as required by or under these regulations or any other law. “

What this essentially means is that the above stakeholders cannot carry out the listed activities unless they have met all the requirements and obligations indicated within the local law. Paragraph 5(2) states the obligations for those persons who would like to carry out the activities above. They must:

  1. Comply with the provisions of these regulations;
  2. Comply with all national and European Union regulations, including international obligations resulting from any treaty to which Malta may from time to time be a part of, as may be applicable;
  3. Obtain the necessary authorisation from the competent authority;
  4. Possess the necessary qualifications and have undergone any necessary training as may be required by the competent authority;
  5. Comply with any other applicable law;
  6. Have a medical device registered person in Malta;
  7. Insert details of all medical devices which he markets locally in the national medical device database kept by the competent authority.

Read our in-depth article on the Medical Device Registered Person (MDRP) requirement and related guidance.

If you are looking into manufacturing, importing, or distributing medical devices or IVDs in Malta, get in touch with us today for a free initial consultation and learn about the services which we can offer.