What is medical device registration?
Registration of a medical or in vitro diagnostic device (IVD) is a formal process of notifying a product to a regulatory authority to obtain the right to legally distribute it. This procedure includes verification of technical documentation, assessment of compliance with legal requirements, and assignment of unique identifiers such as UDI.
In the European system, this process is linked to product classification, the scope of technical documentation, and the quality management system. Registration marks the product’s market entry point but does not end the manufacturer’s obligations.
The role of registration in the product lifecycle
The moment of registration marks the beginning of obligations related to post-market surveillance. The manufacturer must perform clinical performance monitoring, update data, and supervise distribution. For IVDs, registration under the IVDR involves detailed performance evaluation, including analytical and clinical parameters.
Medical device and IVD registration systems – MDR, IVDR, FDA, and others
Registration systems vary by jurisdiction. In the EU, MDR and IVDR regulations apply, requiring CE marking and registration in the EUDAMED database. In the US, the FDA operates the registration system via 510(k), De Novo, or PMA pathways. Canada follows CMDR, while post-Brexit UK uses the DORS platform and requires appointment of a UK Responsible Person.
Key registration steps – step by step
Despite local differences, the registration process consists of key stages:
- Determining the product classification under MDR, IVDR, FDA, or CMDR,
- Selecting the appropriate conformity assessment route,
- Preparing complete technical documentation aligned with harmonised standards,
- Registering the product and economic operators in national databases,
- Monitoring and maintaining up-to-date registration status.
MD and IVD classification
Medical devices are classified into Classes I, IIa, IIb, and III, while IVDs fall under Classes A, B, C, and D. The product class determines the extent of conformity assessment and the need for a notified body. Misclassification can lead to rejection or the need to repeat the entire process.
Conformity assessment and documentation
In the EU, conformity assessment follows Annexes IX–XI of MDR or IVDR. For higher-class IVDs, performance validation is mandatory. Documentation includes GSPR requirements, risk analysis, clinical or analytical data, preclinical testing, IFUs, labels, and traceability evidence (UDI).
Submissions in national systems
In the EU, products are registered in EUDAMED; in the US – in the FURLS database; in Canada – with Health Canada along with a valid ISO 13485 system. Switzerland requires registration with Swissmedic, and the UK – via DORS after appointing a UKRP.
The role of EUDAMED and UDI identification
The EUDAMED database stores data on devices, manufacturers, PRRCs, notified bodies, and economic operators. Device registration includes assignment of a UDI-DI code, which ensures full traceability throughout the supply chain.
Registration in selected regulatory systems
The scope of registration obligations changes depending on the target country. Systems differ in documentation, validation scope, submission language, and document legalization requirements.
Registration in the EU
Registration in the European Union requires CE marking, EUDAMED entry, a QMS implementation, and, for higher-class products, notified body involvement. For innovative or custom-made devices, individual approaches and MDR Article 52-compliant documentation are necessary.
Registration in the USA
The US registration system is risk-based: Class I devices may be exempt from 510(k), while Class II and III devices must undergo a defined process. Documentation must comply with QSR and IVDs must include validation data per 21 CFR Part 809.
Registration in Canada
Registration in Canada under CMDR requires an MDL for Class II and above, and confirmation that the quality system meets ISO 13485. Class I IVDs require notification only, not licensing.
Registration in the UK
The UK registration process is managed by MHRA. All devices must be registered via the DORS platform, and a UKRP must be appointed. Documentation, labeling, and IFUs must comply with UK regulations. IVDs are classified according to a national risk scale partially based on IVDD.
Registration in Switzerland
The Swiss registration system, managed by Swissmedic, requires local registration, appointment of a CH-REP, and access to MDR/IVDR-compliant documentation. Since Switzerland is no longer part of EUDAMED, a separate submission and local language file management are necessary.
Registration in LATAM countries
Registration in LATAM includes diverse procedures. Brazil (ANVISA), Mexico (COFEPRIS), and Colombia (INVIMA) require local data and often an authorized representative. Local performance testing and official language reports may be necessary for IVDs.
Registration in third countries
Registration in third countries comes with additional formal requirements. These include translations, document legalizations, and often the appointment of a local representative. Some markets accept CE documentation, while others require compliance with national standards or regional/provincial registrations.
The role of economic operators in registration
Importers, distributors, and representatives play a significant role in registration. Under MDR and IVDR, they are responsible for ensuring documentation compliance, communication with authorities, and incident reporting in line with market surveillance duties.
Pre-registration audit – readiness assessment
A pre-registration audit allows evaluation of the completeness of documentation and the quality system before submitting the device for registration. It includes checking classification, IFUs, labels, performance data, and alignment with the declaration of conformity. It is a key step in market readiness.
Synchronization with other regulatory processes
Any significant change, new clinical data, or manufacturing updates require registration and documentation updates. Therefore, the registration process must be integrated with PMS, risk management, and vigilance. Lack of synchronization leads to data inconsistencies and market withdrawal risks.
How Pure Clinical supports medical device and IVD registration
Pure Clinical provides comprehensive support for registration processes in the EU, USA, UK, Canada, Switzerland, and LATAM markets. Our support includes:
- classification analysis and selection of the appropriate conformity assessment route,
- preparation of MDR/IVDR and local-compliant documentation,
- coordination of submissions in EUDAMED, FURLS, DORS, and Swissmedic,
- integration of registration data with QMS and PMS systems,
- pre-registration audits and documentation alignment with notified body expectations.
Our services ensure compliant and efficient market entry while minimizing regulatory risks.
FAQ
Does EUDAMED registration allow unrestricted market access across the EU?
What happens if the classification of a device is incorrect during the registration phase?
Are all updates to the technical documentation subject to re-registration?
How long does it take to register a Class C or D IVD in the EU?
Typically between 6–12 months. The timeline depends on the readiness of technical documentation, the notified body’s capacity, and the completeness of performance evaluation and PMS planning. Class D devices may face additional scrutiny such as type examination.