Regulatory Database Support

Manufacturers selling internationally must register in a different database for each market, not just one. The main systems are EUDAMED in the EU, the FDA’s Global Unique Device Identification Database (GUDID) in the US, and SwissDAMED in Switzerland, alongside UK MHRA registration, the Australian Register of Therapeutic Goods (ARTG) (by the local sponsor), and Health Canada’s licensing and Medical Devices Active Licence Listing (MDALL).

Each has its own identifiers, data fields, and timelines, so a single registration rarely satisfies more than one market.

EUDAMED (the European Database on Medical Devices) is the EU’s central IT system for registering devices, economic operators, certificates, clinical data, vigilance, and market surveillance. It is established under Article 33 of the Medical Device Regulation (MDR 2017/745) and Article 30 of the In Vitro Diagnostic Regulation (IVDR 2017/746). Its modules are being made mandatory in stages under Regulation (EU) 2024/1860, once each is audited and declared functional. 

A Single Registration Number (SRN) is the unique identifier the EU assigns to each registered economic operator, manufacturers, authorised representatives, and importers, and it is required before you can register devices in EUDAMED. You obtain it by submitting an actor registration, which is then validated (for non-EU manufacturers, by their authorised representative). Actor registration is governed by Article 31 of the MDR 2017/745. MedQAIR provides actor registration and SRN support.

The Basic UDI-DI is the main EU database key that groups devices sharing the same intended purpose and essential characteristics; it appears in the technical documentation, declaration of conformity, and certificates, but not on the label. The UDI-DI identifies the specific device model and packaging level shown on the label, while the UDI-PI (production identifier) captures lot, serial number, or expiry date. These are defined under Article 27 of the MDR 2017/745; the Basic UDI-DI is an EU concept that other databases such as GUDID do not use.

Manufacturers, authorised representatives, and importers must register as actors in EUDAMED and obtain a Single Registration Number (SRN), and manufacturers must additionally register their devices and UDI data. Distributors are not assigned an SRN but carry related traceability duties. These obligations flow from Articles 29 to 31 of the MDR 2017/745 and the equivalent provisions of the IVDR 2017/746. System and procedure pack producers also have registration obligations.

The Global Unique Device Identification Database (GUDID) is the FDA’s US database holding the device-identifier information that manufacturers (labellers) submit for each device under the UDI Rule, required by 21 CFR Part 830 and section 519(f) of the Federal Food, Drug, and Cosmetic Act; its public interface is AccessGUDID. Unlike EUDAMED, GUDID is limited to device-identification data, it does not cover actor registration, certificates, vigilance, or clinical data, which the FDA handles through separate systems.

SwissDAMED is Switzerland’s medical device database, operated by Swissmedic, and registration is required because Switzerland is treated as a third country for medical devices after its mutual recognition agreement with the EU was not updated for the MDR. Manufacturers outside Switzerland must appoint a Swiss authorised representative (CH-REP) and comply with the Swiss Medical Devices Ordinance (MedDO). SwissDAMED is being introduced in phases, beginning with actor registration and followed by UDI and device modules.

Yes, each operates its own registration system that must be completed before market access. In Great Britain, devices are registered with the MHRA (through its Device Online Registration System) under the UK Medical Devices Regulations 2002; in Australia, devices must be entered on the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration; and in Canada, devices require licensing that is recorded in the Medical Devices Active Licence Listing (MDALL).

Often yes, the same UDI issuing agency can usually be used across markets, because GS1, HIBCC, and ICCBBA are recognised both as FDA-accredited issuing agencies in the US and as European Commission-designated issuing entities in the EU (which also recognises IFA). However, the data each database requires differs: EUDAMED uses the Basic UDI-DI as its key, a concept GUDID does not use. So the identifier may carry across markets while the underlying records and data fields do not.

Yes, registration is market-specific, so a device sold in the EU, US, Switzerland, and elsewhere must be registered in each jurisdiction’s database with its own data set and deadlines. The core device information overlaps heavily between systems, so the efficient approach is to maintain one harmonised master data set and map it to each database’s requirements. MedQAIR helps manufacturers structure registration data so it can be reused consistently across EUDAMED, GUDID, and other databases.

Registration data must stay consistent with your technical documentation, labelling, and certificates, because the same identifiers and device details appear across all of them. In the EU the Basic UDI-DI links a device to its technical documentation and declaration of conformity under Article 27 of the MDR 2017/745, and the UDI carrier must appear on the label; GUDID, SwissDAMED, and other systems impose comparable labelling and data-consistency expectations. Mismatches between these records are a frequent source of audit findings.

Inconsistent data across registration databases can block registration, delay market access, and trigger findings during Notified Body, FDA, or competent-authority review, because these systems underpin device traceability. Problems usually stem from mismatches between UDI data, labelling, and technical documentation, or from records updated in one database but not another. MedQAIR carries out registration gap assessments and data reviews across EUDAMED and other databases to find and resolve these issues before they affect compliance.

Each database requires changes to actor, device, or UDI data to be updated within its own timelines, and some changes, such as certain UDI-DI changes,require a new identifier rather than an edit to the existing record. Managing this across EUDAMED, GUDID, SwissDAMED, and others over a growing portfolio needs a defined internal workflow. MedQAIR provides workflow guidance and ongoing registration maintenance support to keep records current and aligned across markets.

Yes. MedQAIR supports organisations across the full registration lifecycle in multiple markets, including EUDAMED actor registration and SRN support, Basic UDI-DI and UDI-DI structuring, device registration preparation, economic operator coordination, registration gap assessments, data reviews, and ongoing maintenance, aligned with MDR, IVDR, FDA, and other applicable requirements. You can schedule a free consultation with MedQAIR’s specialists to discuss your multi-market registration strategy.