Question 1

What is a Class I medical device?

Accepted Answer

Class I devices are generally considered to pose a low risk to patients and users. They include most non-invasive devices. Unlike the higher risk classes (IIa, IIb, III), conformity assessment for "classic" Class I devices is the sole responsibility of the manufacturer.

Question 2

Where should I register my device and myself?

Accepted Answer

You must register as a manufacturer in the European EUDAMED database before placing your first device on the market or submitting an application to a notified body. You will then get a unique registration number.

You must also register each device model (using its Basic UDI-DI) that you place on the European market in the EUDAMED UDI database. This registration must take place before the device is placed on the market.

Note: Manufacturers who only make custom devices are not required to register their devices or themselves in EUDAMED.

Question 3

I make custom devices. Do I still have to register them in EUDAMED?

Accepted Answer

No, manufacturers of tailor-made devices do not have to register their devices in EUDAMED, nor do they have to register themselves in this database if they only place this type of device on the market. Custom devices follow a different specific process.

Question 4

What are the main steps to be able to sell my Class I medical device in Europe?

Accepted Answer

To legally place your Class I device on the European market, you must:
Ensure that your device complies with the regulatory requirements in terms of design and manufacturing.
Establish a quality management system (QMS).
Implement risk management for your system.
Carry out a clinical evaluation to demonstrate that your device is safe and efficient.
Prepare the technical documentation for your device.
Obtain and use a Unique Device Identifier (UDI) for your product.
Register yourself as a manufacturer and register your device in the European EUDAMED database.
Establish an EU Declaration of Conformity attesting that your device complies with all the rules.
Affix the CE marking to your device.
Establish a post-market surveillance and vigilance system to track your device once it is on the market.
Have sufficient financial coverage for liability in the event of default.
Designate a Person Responsible for Ensuring Compliance with the Regulations (PCVRR).

Question 5

Do I need to use a notified body?

Accepted Answer

No, not for all Class I devices. For "conventional" Class I devices (which are not sold sterile, do not have a measuring function, and are not reusable surgical instruments), the manufacturer assesses conformity themselves.
However, if your Class I device is placed on the market sterile, has a measuring function, or is a reusable surgical instrument, you must involve a notified body. This body's involvement is then limited to aspects related to sterility, the measuring function, or reprocessing (for reusable instruments).

Question 6

What is technical documentation and what should it contain?

Accepted Answer

Technical documentation is a file that you must establish and keep up to date for each device. It proves that your device complies with regulatory requirements. It must be clear, organized and easy to consult.

For Class I devices, it must contain the elements detailed in Annexes II and III of the regulation. This includes in particular:

A description and specifications of the device, including its intended use (destination).
The information you provide with the device (labels, instructions for use).
Information on design and manufacturing.
How you have met general safety and performance requirements.
Benefit/risk analysis and risk management.
The results of your product verification and validation activities.

Question 7

If my device has a measuring function but I am not sure of its classification, who can decide?

Accepted Answer

If you are in doubt about the classification or scope of the regulation for your product, including in borderline cases, a Member State can decide on a case-by-case basis. The European Commission, after consulting the group of experts (GCDM), can also issue decisions to ensure a consistent approach between Member States.

Question 8

My device was certified under the old directive (MDD). Can it continue to be sold as is?

Accepted Answer

Devices legally placed on the market under the old directives (90/385/EEC and 93/42/EEC) ("Legacy Devices") may continue to be made available on the market under certain transitional conditions. These conditions include maintaining compliance with the requirements of the old directive and no significant changes in design or purpose. You may need to register these devices in EUDAMED by assigning them a specific Basic UDI-DI. Post-marketing surveillance and vigilance obligations apply according to the new regulation even for these devices.

Question 9

Which economic operators are required to register in the EUDAMED Actors module?

Accepted Answer

The EUDAMED Actors module allows economic operators to register and obtain a unique actor identifier or registration number (Actor ID/SRN). Economic operators required to register include manufacturers, assemblers (system and kit manufacturers), agents (for non-EU manufacturers) and importers.

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