Medical Device Registration
All Medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered in the relevant countries or economic areas before they can be placed on the market.
The Regulatory Authorities will only accept registration from manufacturers based in the countries or economic regions where they are located, such as an EU member state country for CE marking or the UK for UKCA marking.
If a medical device manufacturer is based outside of those countries or areas, the manufacturer needs to appoint a representative to register their devices in the relevant country on their behalf.
This is known as an Authorised Representative in the EU or a Responsible Person in the UK. In other countries they can also be known as an agent such as in the USA.
The representative is a registered business where the Regulatory Authorities can contact for the purposes of any regulatory communication required between them and the manufacturer, including communication in relation to medical device post market surveillance and vigilance requirements.
It important for the representative to hold copies of the manufacturers technical documentation so that this can be provided to the authorities or Notified Bodies (if applicable) if requested or in the case of an unannounced audit.
Patient Guard has registered offices based in the UK and the EU (Germany) and are able to offer medical device companies based outside of these regions, medical device registration for the purposes of CE marked and UKCA marked medical devices.
If you require medical device registration services or need support, then please contact us for further information.
EU Medical Device Registration
The European Union (EU) requires medical device manufacturers based outside of the EU to appoint an EU Authorized Representative who…