In order to sell their products on the European market, manufacturers of medical-diagnostic devices must meet legal requirements and provide a CE Declaration of Conformity.
For high risk devices, the manufacturer must be in possession of the appropriate CE Declaration of Conformity issued by a Notified Body established in the European Union.
The SSCP (Summary of Safety and Clinical Performance) document contains important information for the users of medical devices. It gives patients and health professionals access to an updated summary on the safety and clinical performance of medical devices.
Importance of language and translation
The SSCP document is a further regulatory tool in the context of the ongoing search for transparency by the European medical-scientific community. Although public disclosure of research results is not new, the new EU regulation on medical devices and the new EU regulation on clinical trials (CTR, Clinical Trial Regulation) will now legally require simple language.
In both the new EU regulations, language and readability are fundamental for presenting patients with results in simple non-technical local terms.
After validation of the initial SSCP document by the notified body based on one single agreed language, this master document then has to be translated into all the relevant EU languages according to the reference market.
Translation of declaration of conformity for medical devices
The drafting of documents for devices used directly by patients containing a part intended for the health professionals and another part for the patients is particularly complex in terms of language. It may also be necessary to consider other recipients: children or adolescents, and therefore parents, or the elderly.
Obviously, given the close correlation between all these documents, coherence of content and management of files in various languages pose linguistic challenges in terms of the need to address different targets in the same document.
The ability to adapt the language to the end user of the medical device requires an in-depth knowledge of the reference terminology and technical jargon.
ALG Language Consulting works with professionals who have specific experience in the translation of this type of document.
Glossaries and terminological databases are precious tools for this work as they provide the terms officially used by specific firms or a particular market niche.
The availability of glossaries and terminological sources therefore enables the translator to work faster, more accurately and consistently.
If you need to translate a declaration of conformity, contact ALG Language Consulting.