Understand The Manufacturer, Importer And Distributor Responsibilities For Ce Marking And Its Actions

By Author: John
Total Articles: 212
Comment this article

The French word "Conformité Européene," which means "European Conformity," is shortened to "CE" in the CE marking symbol. According to EU Directive 93/68/EEC, "CE marking" has legally taken the place of the phrase "EC Mark," which was previously used to define "CE." Although "EC Mark" is still used in the common language, CE marking is utilized in all official EU documents. If you now refer to EC Marking in your documentation, you should switch to CE Marking going forward.

In addition to all of the European Union's member states, Iceland, Liechtenstein, Norway, and Switzerland, the letters "CE" can be seen on a variety of products that are sold on the Single Market. Simply explained, the CE mark is a symbol of mandated conformity that informs the user that a product has the CE mark because it complies with all applicable EU directives and rules.

Not only medical equipment but all products must have the CE label. The CE logo can be seen on a variety of products, including cell phone chargers, toys, laptop batteries, wheelchairs, and construction equipment. Only those goods for which EU requirements exist and CE ...
... marking is necessary must be made and sold in the EU to be eligible for CE marking.

Manufacturer responsibilities for CE marking
Before products leave the warehouse, manufacturers of medical devices have a responsibility to properly and legally CE mark products. Before being allowed on the market, the majority of Class II and III medical devices, as well as IVDs and some Class I devices, must pass a conformity assessment conducted by a Notified Body. Most Class I device manufacturers can evaluate their conformance. This procedure must show that all legal requirements, including any testing and inspections, are met, and that all required certificates have been received. Manufacturers should follow these 6 procedures, according to the European Commission, to add a CE mark to their products:

1. Find the relevant directive(s) and harmonised standards by consulting the EU standards for medical devices, in vitro diagnostic (IVD) devices, and implantable medical devices.
2. Utilize the fundamental concepts outlined in the aforementioned standards to validate the product-specific requirements.
3. Identify whether a Notified Body's impartial conformity evaluation is required. The majority of medical devices categorized as IIa, IIb, or III, together with sterile class I devices, will require notification bodies to confirm compliance with relevant Essential Requirements. For notified bodies that are still available, consult the Notified and Designated Organization (NANDO) database.
4. Product evaluation and conformance verification
5. Make the necessary technical CE Mark documents available and keep them up to date
6. Create the EU Declaration of Conformity and attach the CE marking.

Importer responsibilities for CE marking

It is your responsibility to study all technical documentation if you are importing medical equipment into the EU and to keep a copy of it on hand for reference. Also, the device has been CE marked and the EU declaration of conformity has been completed. The manufacturer has designated and established an authorized representative. Also, the item has the proper labelling and IFU (instructions for usage). A UDI has been given to the product when it is eligible. whether the item is registered in EUDAMED (registration is presently optional).
Take action:

• In addition to the manufacturer's details, print your name and address on the product or container.
• Maintain a file of all complaints, non-conformities, recalls, etc.
• Any observed non-conformity or product complaints from customers should be reported right away to the manufacturer and authorized agent.
• Keep a copy of the declaration of conformity issued by the EU as well as any other pertinent certificates.

Distributor responsibilities for CE marking

If you are a distributor, you must carefully read the technical information given to you so that you can confirm the product is secure to sell on your local market. Additionally, make sure the CE mark certification symbol is visible on the product's label. The technical file documentation includes all the data required to demonstrate how the product complies with all relevant requirements. The device's CE marking and the completion of the EU declaration of conformity must both be confirmed. The device also has all the necessary labelling, including usage guidance. Whenever something is imported, the importer complies with all EU rules. A UDI has been given to the product when suitable.
Take action:

• Any non-conformity should be reported right once to the manufacturer, importer, and authorized representative.
• The manufacturer, importer, and authorized representative should be notified as well as the Competent Authority if a product looks to be out of conformity with the rules and poses a major risk.
• Any issues with the product should be brought to the manufacturer's attention, as well as, if necessary, the importer and authorized agent.

Source: https://cemarkprocedures.wordpress.com/2023/09/14/understand-the-manufacturer-importer-and-distributor-responsibilities-for-ce-marking-and-its-actions/