4 tips for translating a UE declaration of conformity

Does translating a UE declaration of conformity for a medical device seem too complicated?

Let us give you 4 tips for a successful translation!

What is a UE declaration of conformity?

Firstly, you need to know that in order to market a medical device in the European Union, you need to complete a UE declaration of conformity.

To recall, a medical device is any health product (equipment, apparatus, material, etc.) designed by the manufacturer for use in humans to diagnose, prevent, control, treat or alleviate a disease or injury.

The declaration of conformity, or EU declaration of conformity, is a declaration made by the manufacturer that a product placed on the market conforms to the regulatory requirements of European legislation on quality, safety and performance, with a view to its free movement throughout the European Union.

By signing this document, the manufacturer assumes all responsibility for the compliance of its product with the applicable EU legislation before the national authorities. 

Indeed, the Regulation 2017/745 of the European Parliament and of the Council on medical devices states that: “When drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device”.

The declaration of conformity must be made available. It must be available to ensure that the product complies with current European regulations.

As stated in the Regulation 2017/745 of the European Parliament and of the Council on medical devices, Article 6: “Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned ”.

How can it be translated?

The translation of a declaration of conformity for medical devices is a complex process. It requires attention to detail. 

It must be well translated to ensure the quality, safety and performance of medical devices on the European market.

Here are our four tips to help you successfully translate your declaration of conformity for medical devices:

Tip 1. To know the regulations in force concerning CE marking

First of all, you should know that CE marking is mandatory for all products covered by one or more European regulations, i.e. directives or regulations.

Products that are not covered by these texts are prohibited from using this marking.

Examples of products covered by the declaration of conformity

In order to determine whether a product should bear the CE marking, it is crucial to consult the texts of the relevant directives and technical harmonisation regulations.

There are several categories of products that require CE marking. 

As is the case with the Regulations 2017/745 and 2017/746 (formerly 93/42/EEC, 90/385/EEC and 98/79/EC) on medical devices.

The declaration of conformity is mandatory for products subject to the European Medical Device Directive (MDD) or the new Medical Device Regulation (MDR) which replaces it from 26 May 2020.

In order to market a medical device in the European Union, you will have to affix the CE marking.

Manufacturers are required to comply with regulatory requirements in order to place a product on the European market.

As the Regulation 2017/745 of the European Parliament and of the Council on medical devices states in Article 13: “In order to place a device on the market, importers shall verify that the device has been CE marked and that the EU declaration of conformity of the device has been drawn up”.

For this reason, an incorrect translation of the declaration of conformity may have highly negative consequences. 

We'll give you a second piece of advice so that this doesn't happen.

Tip 2. Gather the necessary information

In order to make a good translation of the EU Declaration of Conformity, gathering information about the product is a crucial step.

But what information do you need to translate the declaration of conformity of a medical device?

As a reminder, the declaration of conformity is a document in which the manufacturer attests to the conformity of its product. 

In this declaration you will find:

• The identity of the manufacturer: name, address and identification number,
• The identity of the product: name, model number, serial number,
• A declaration by the manufacturer to take full responsibility for the conformity of the product,
• References to European standards applicable to the product,
• The compliance procedure used to assess the product,
• The results of the conformity assessment,
• The name and signature of the person responsible for the declaration of conformity,
• The date of the declaration.

You can find more details on this information in Annex IV of the Regulation 2017/745 of the European Parliament and of the Council on medical devices.

It is essential that you have this information in your possession, otherwise the translation of the declaration of conformity will not be compliant.

Once you have all the information, let's dive into translation!

Tip 3. Using an experienced translator 

Of course, not everyone can translate a declaration of conformity...

In order to know which languages to translate your declaration of conformity into, you should also be aware of the laws and language regulations in force in the countries where you wish to market your medical device.

Medical devices marketed in the European Union must comply with the standards of the European Regulation 2017/745/EU on medical devices. 

The Regulation requires that the declaration of conformity for medical devices be translated into all official languages of the Member States where the product is marketed (up to 24 different languages). 

In addition, the translator must respect the language requirements of the target country. 

Make sure you choose a professional translator who has a thorough knowledge of the regulations in force, the requirements for translating this type of document and the appropriate technical vocabulary. 

They must also have expertise in health and medical devices. 

You can also use a translation agency to translate the declaration of conformity for your medical device. 

Make sure you choose one that has a team of experienced and competent translators in the field, as well as a successful track record in medical device translation. 

Also choose a translation company with ISO 17100 quality certification.  It ensures a rigorous quality process to guarantee the quality of its translations through the proofreading of the translation by a second professional. 

A translation company that also has ISO 13485 quality certification is a real plus, especially in the translation of medical devices. It demonstrates the commitment to the quality and safety of the products marketed, in compliance with regulations, customer requirements, and the control of the activity and risks. 

Translation errors can have serious consequences for the reputation and business of manufacturers of these medical devices, but also for the health and safety of consumers. 

Furthermore, an incorrect or incomplete translation of the declaration of conformity of a medical device can have several serious consequences. You can deal with:

• A refusal to market: the regulatory authorities may refuse to approve the medical device,
• Withdrawal from the market: if the medical device is already on the market and an incorrect translation of the declaration of conformity is discovered, it may be withdrawn from the market,
• Legal action: if the mistranslation causes damage, the manufacturer being held responsible may be subject to legal action,
• Financial penalties: regulatory authorities may impose financial penalties on manufacturers for regulatory violations,
• Damage to your reputation: a bad translation can lead to a loss of consumer confidence in a manufacturer or brand.

It is therefore essential to use an experienced and qualified translator to translate declarations of conformity for medical devices. 

To avoid all these problems, we strongly advise you to use a translation company specializing in the medical device industry.

Tip 4. Updating the declaration of conformity

Regularly updating the declaration of conformity of medical devices is a crucial step to ensure that they remain in compliance with current regulations.

Be sure to update it regularly to reflect changes in the product or regulations.

In Article 15 of Regulation 2017/745 of the European Parliament and of the Council on medical devices, it is stated that "The compliance officer shall at least be responsible for ensuring that the technical documentation and the EU declaration of conformity are established and kept up to date".

We will share with you some reasons why it is important to update the declaration of conformity of a medical device:

• Regulatory changes: Health and safety regulations can change and evolve over time. It is therefore important to ensure that your declaration of conformity remains in line with the new regulations,
• Technical improvements: medical devices can also evolve and be modified. This requires amendments to the declaration of conformity,
• Error correction: it is necessary to correct any errors in the declaration of conformity,
• Quality monitoring: regular updating of the declaration of conformity can help monitor the quality of medical devices and ensure that they are safe for consumers to use.

Regular updating of the declaration of conformity can therefore help to ensure the quality and safety of medical devices for consumers, as well as helping to maintain regulatory compliance.

Conclusion: The need to follow these 4 tips for the successful translation of a medical device declaration of conformity

In conclusion, the translation of a declaration of conformity for medical devices is a complex process. It requires careful attention to regulatory compliance, collection of necessary information, the use of an experienced translator and constant updating of the declaration. 

By following these 4 tips, you can be sure that your declaration of conformity will be correctly translated and compliant with the relevant regulations!

In this way, you can guarantee the safety and effectiveness of your products in international markets.

Do not hesitate to call our medical translation services to ensure an accurate, complete and compliant translation!

So translating UE declarations of conformity for medical devices is no longer a secret for you?

If you have any questions, please feel free to leave a comment below. We are always happy to answer your questions!