Malta medical device regulations

Malta is an EU member State, so Regulation (EU) 2017/746 applies directly; as with the MDR there is no Maltese instrument restating it, and the national layer is the same S.L. 458.59 and GL-MDF/GL-MDS notes, which are written to cover in-vitro diagnostic devices alongside medical devices. The text is expressed once in eu.ts as eu-ivdr-2017-746; this row is the Maltese metadata view onto it and opens the articles those documents apply: manufacturer obligations (Art. 10), the authorised representative (Art. 11), importer and distributor obligations (Arts. 13 and 14), the EUDAMED registration and the summary of safety and performance (Arts. 27 to 29) and the derogation from the conformity assessment procedures that GL-MDF19/02 and the L.N. 254 of 2025 fee schedule administer for IVDs (Art. 54). It is not a second corpus copy.

Malta is an EU member State, so Regulation (EU) 2017/745 applies directly and sits above S.L. 458.59, which designates the Medicines Authority as competent authority and carries the national market-notification, registered-person and complaint-forwarding duties, with the Authority’s GL-MDF and GL-MDS notes as the application surface. The text is expressed once in eu.ts as eu-mdr-2017-745; this row is the Maltese metadata view onto it and opens the articles the national layer hangs off: manufacturer obligations (Art. 10), importer and distributor obligations (Arts. 13 and 14), the EUDAMED registration behind the organisation-registration and device-notification notes (Arts. 30 and 31, Art. 30(2) being the provision that lets Malta keep a national notification step), the derogation from the conformity assessment procedures that GL-MDF19/02 and the L.N. 254 of 2025 fee schedule are built around (Art. 59), vigilance (Art. 87) and the transitional provision the Authority’s own factsheet cites as the basis for the continuing registration of economic operators and devices (Art. 120(3)). It is not a second corpus copy.

Medicines Authority guidance note GL-MDF02/05, Ref No. GL-MDF02/05, February 2026, on the application for organisation registration in relation to medical devices. It is the authority's own step-by-step note for the registration of the organisation itself — the first registration an importer, distributor or manufacturer established in Malta completes — and it is ingested because that registration is a national requirement that sits under, and is not displaced by, the directly applicable Union regulations.

Medicines Authority guidance note GL-MDF05/06, Ref No. GL-MDF05/06, February 2026, on the application form for notification of medical devices made available on the local market. Malta keeps a national notification step for devices placed on its market on top of the Union rules, and this note is the authority's statement of what the notification covers and how the form is completed.

Medicines Authority guidance note GL-MDF19/02, Ref No. GL-MDF19/02, February 2026, on application forms MT-MDF12 and MT-MDF13 for a derogation from the conformity assessment procedures of medical devices. This is the national surface for the derogation route by which a device may be placed in service without the applicable conformity assessment procedure having been carried out, and the note states which form applies to which case. The note carries a reference list of the other GL-MDF and GL-MDS notes, which is retained in the extract rather than stripped as page furniture.

Medicines Authority guidance note GL-MDF21/02, Ref No. GL-MDF21/02, August 2025, on the application for a medical device or in-vitro diagnostic evaluation of risk classification. It is the Maltese route by which an applicant asks the authority to evaluate the risk class of a device, and it is the classification-specific guidance note in the authority's GL-MDF series. This is the shortest of the five guidance notes ingested, at eight blocks.

Medicines Authority guidance note GL-MDS01/04, Ref No. GL-MDS01/04, November 2024, on good distribution practice in relation to medical devices. It is the longest document in this market's set — thirteen numbered sections, a reference section and two annexes — and it is the authority's substantive statement of the distribution requirements that importers and distributors established in Malta must meet. The two annexes are ingested as annex blocks so that they are separately citeable from the sections that reference them.

Legal Notice 254 of 2025, gazette pages B 2297–B 2309, in two Parts. Part I amends the Licensing Fees for Private Medical Premises Regulations (S.L. 458.26), including the Schedule to the principal regulations. Part II amends the Medicines Authority (Fees) Regulations (S.L. 458.46): it amends regulations 2 and 3 of the principal regulations, substitutes Schedules 1 to 4, and adds new Schedules. Schedule 5 as substituted — "Fees related to Medical Devices and In Vitro Diagnostic Medical Devices (regulation 3)" — is the device-relevant part and is ingested in full, together with Schedules 1–4 and 6, because the device fees are read against the general fee structure. The triage row declared this document against S.L. 458.46; the instrument is an amending legal notice with its own L.N. number, not a section of 458.46, and it is recorded that way here. The copy prints no publication date, so no publishedDate is asserted.

Undated Medicines Authority factsheet for importers and distributors, in nine numbered sections: an introduction to the medical devices regulations; what happened on 26 May 2021 (the date the Union regulations became applicable); what type of economic operator the reader is, with the importer-or-distributor distinction; the obligations that follow; the application forms that apply; timelines; the systems that must be in place, namely good distribution practice and a quality management system; relabelling; and where to get more information. The copy prints no issue date, reference number or revision, so none is asserted; the lastVerifiedOn date records only the calendar day the bytes were checked. The document is written in two columns on its later pages, and the extract preserves the printed reading order — left column to the foot of the page, then right column — rather than pdftotext's row-interleaved output.

Union instrument, expressed once in eu.ts as eu-regulation-2023-607. This Maltese row is a metadata view onto that expression; it is the instrument that extended the MDR transitional periods for devices covered by a valid Directive 90/385/EEC or 93/42/EEC certificate (Article 120(3a) to (3f)), and the corresponding IVDR period in Article 110(4), which is what a Maltese certificate holder reads the deadline from and what decides how long those certificates remain a route into the Maltese market. It is not a second corpus copy.

Subsidiary legislation of Malta made as Legal Notice 321 of 2020 and published on 4 August 2020, in eleven regulations: citation; interpretation; designation of the competent authority and the accrediting body; administration; importation, wholesaling, manufacturing or re-purposing of medical devices; the obligation of the medical device registered person; issuing of approval; issue of guidelines; monitoring and review of operations; the obligation of economic operators to transmit complaints to the competent authority; and fines and penalties. Regulation 3 is the provision that makes the Medicines Authority the competent authority, which is why the registry regulator label is used for this row. The copy ingested is the instrument as made and shows no amendment history. It is the only Maltese instrument in the corpus that names medical devices, in-vitro diagnostic medical devices and their economic operators in a single text.