Product Registration

Now the hard work is done, registering your product on the relevant regulatory databases is the final step to legally place your product on the market.

Registration in the EU

For the European Union (EU) market authorisation of medical devices and in vitro diagnostic devices, you must register your manufacturer and product information centrally in the European database on medical devices (EUDAMED) database.

EUDAMED system includes components related to actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance. In order to gain access to EUDAMED, economic operators such as manufacturers, importers and authorised representatives can register in the EUDAMED to receive a single registration number (SRN). This SRN number allows access to the EUDAMED system.

Prior to registering on EUDAMED, each CE-marked device will need to be assigned a Unique Device Identification (UDI) number.

These codes allow for the unambiguous identification of a specific medical device on the market which is comprised of the following:

• Basic UDI-DI: numeric or alphanumeric characters for grouping medical devices with the same purpose, risk class, comparable design and manufacturing characteristics.

• UDI-DI (static part of the UDI): numeric or alphanumeric characters that are specific to the device model that remains the same for the product unless substantial changes are made to the product.

• UDI-PI  (dynamic part of the UDI): numeric or alphanumeric characters that are production identifier that relates to a software version number and release date.

Registration in the US

Regardless of the classification of your technology, all devices intended for use in the US that fall under the FDA’s oversight must be registered annually with the FDA. This process, known as Establishment Registration is described in the Code of Federal Regulations 21 CFR Part 807. 

Importantly, if you are a non-US company intending to market your product in the US, you must engage a US Agent, as described in 21 CFR Part 807.40 Subpart C. The US Agent will be the responsible mediator of assisting the FDA with any communications, responding to FDA’s questions, and assisting FDA inspections if applicable. A caveat to be aware of: your US Agent is not required to report adverse events or 510(k) Premarket Notifications on your behalf - that remains your responsibility unless it is a service explicitly offered by your US Agent.

Registration in Great Britain

For the Great Britain market authorisation of medical devices and in vitro diagnostic devices, all devices must be registered on MHRA Device Online Registration System (DORS) by you as a UK based manufacturer before being placed in the market by providing manufacturer and device details.

If you are a manufacturer based outside of the UK, then you must appoint a UK Responsible Person (UKRP) based in the UK who can take responsibility for registering your device to MHRA DORS.

Note that EU MDR (since 26 May 2021) and EU IVDR (since 26 May 2022) regulations have been applied in Northern Ireland.