Making Medical
Devices Simple

Do I need a Notified Body to get CE marking under EU MDR?

It depends on your device's classification. Most Class I devices (excluding sterile, measuring or reusable surgical instrument variants) can self-certify, but Class Is, Class IIa, IIb and III devices all require Notified Body involvement before you can affix the CE mark under EU MDR. Notified Body capacity is tight and timelines vary by body, so it's worth confirming your classification early and approaching the right Notified Body well ahead of your target launch date.

What is EUDAMED and do I need to register on it?

EUDAMED is the EU's central database for medical devices, linking economic operators, device registrations, certificates, clinical investigations and vigilance data across all member states, and yes, manufacturers, Authorised Representatives and importers all need to register on it under EU MDR. Some modules are still rolling out on a phased basis, so what's mandatory right now depends on which parts of EUDAMED are live at the time you register.

What is an EU Authorised Representative and when do I need one?

An EU Authorised Representative is an EU-based entity that a non-EU manufacturer must appoint under MDR Article 11 to act on their behalf with EU authorities, handling registration, vigilance and acting as the local point of contact. If you manufacture outside the EU and want to place a device on the EU market, you need one appointed before you can register on EUDAMED or affix the CE mark. We provide EU Authorised Representative services for manufacturers without an EU base.

What's the difference between Class I, IIa, IIb and III devices under EU MDR?

EU MDR classifies devices from low-risk Class I through to higher-risk Class III based on factors like invasiveness, duration of contact with the body, and whether the device is active, with Class IIa and IIb sitting in between as increasing levels of risk. The class you land in decides how much clinical evidence you need, whether a Notified Body gets involved, and how detailed your technical documentation has to be, so getting it right early really does drive everything downstream.

How long does EU MDR certification take?

There's no fixed timeline. It depends on your device's classification, how much clinical evidence you already have, and how much Notified Body capacity is available for your device type, which has been a genuine bottleneck since EU MDR came into force. A well-prepared Class I self-certified device can move relatively quickly, while a higher-risk device needing a Notified Body and fresh clinical data can take considerably longer, so building in realistic lead time matters.

What is a GSPR checklist and why does EU MDR require one?

A GSPR checklist maps your device's technical file against the General Safety and Performance Requirements set out in EU MDR Annex I, showing exactly how and where each requirement is met. It's required for every device regardless of class, and it's usually one of the first documents a Notified Body or regulator checks, because it's essentially the index to your whole technical justification.

How easy is it to switch EU Authorised Representative to a new provider?

It's generally a smooth administrative process rather than a regulatory hurdle. Your new EU Authorised Representative takes on your existing technical documentation and EUDAMED registration, confirms your device details are current, and updates the Authorised Representative information in the portal and on your labelling. We manage that handover directly with your previous provider, so your device stays compliant and on sale throughout the switch.

What does an EU Authorised Representative actually do?

An EU Authorised Representative carries legal accountability for a device across the EU market, covering EUDAMED registration, holding technical documentation available for inspection, handling vigilance reporting, and acting as the contact point for national competent authorities if a device is ever questioned. It's a standing obligation for as long as the device is on sale, not something that ends once the initial registration is filed.

Do medical device labels and instructions for use need to be in the local language of each EU country I sell in?

Yes, in most cases. EU MDR requires labelling and instructions for use to be provided in the official language, or languages, of the member state where the device is being made available, so a technical file built for one EU country typically needs local-language versions before the device can be sold elsewhere. Your underlying technical documentation and GSPR checklist stay the same; it's the label and IFU translations that need to be handled market by market.

Still have questions? Contact us and we'll be happy to help.