It’s time to clarify which documentation the MDR applies to, the scope it covers following recent updates.

Instructions for Use (IFUs)

• IFUs for CE marked products will now have to match the stipulations of MDR. You need to check the IFUs against the new requirements, so you can fill in any gaps.
• The patient information must state clearly the purpose of the medical device, and where applicable, what the clinical benefits would be.
• For devices that will be inserted in the body, IFUs have to specify the materials used to make the device.
• If a device is meant for lay users, IFUs have to include circumstances, if any, where they must consult with their doctors before using it.
• The IFU must mention the expected life of the product and if any follow-up checks are required.

Summary of Safety and Clinical Performance (SSCP)

The SSCP is another critical document required by the MDR. It includes design verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (PMS), and post-market clinical follow-up (PMCF) plans and reports.

Content for the SSCP can be primarily derived from the IFU, where applicable. The SSCP of each device will be made publicly available on Eudamed, the European database on medical devices.

The entire Instructions for Use (IFU), along with the updated content, the Summary of Safety and Clinical Performance (SSCP), and other technical documentation as required by Annexes II and III, must be translated into all the languages of the EU countries where the product will be sold. This information needs to be accurate and written in plain language to ensure accessibility for non-medical professionals. Specialized content with medical jargon must be simplified.

Any changes made to the device or documentation in one language must be reflected in all other language versions. The Notified Body will validate the documents in one language.

For subsequent translations, the company can ensure quality in two ways:

1. The company’s regulatory affairs department or legal counsel in each country can validate the translations.
2. If there is no in-country counsel, the company can use a back translation process. This involves translating the document back into the source language and comparing

it with the original content to ensure accuracy. The translation agency performing the back translation should be different from the one that did the original translation.
A translation certificate is highly recommended to accompany the translated documentation when applying for certification.

If all required content under the MDR is not translated into the languages of the countries where the device will be sold, the device will not receive CE certification, resulting in a loss of market access. Thus, accurate translation is crucial.

Choose translation partner with care

As every improvement or change to the product or its packaging would result in cascading content, translation is a process that life sciences companies have to integrate with their business processes. It’s not a one-time event any more. It’s a constant, continuous service that you will need.

It is all the more reason to choose your language partner with care, as it can make a difference between being able to sell in Europe or not. Keep in mind the below when selecting a multilingual medtech content company:

• To begin with, your translation company must have experience in creating and managing multilingual content for medtech companies. It is highly recommended that they already have the tech infrastructure, especially terminology management and translation management tools as this will enable faster work. It must be familiar with regulatory requirements that relate to content, so that it can audit your content and advise you on gaps that need to be filled.
• This process of assessing the content gap can be time-consuming, as it has to be done for all the patient manuals of CE-marked products. Very few life sciences content companies have content management systems (CMS) to systematically identify and fill the gaps. A CMS is critical in doing this as it saves a lot of time, maintains versions, and brings transparency.
• The content company must have a solid, multi-level review process to meet the stringent requirements of MDR. This ensures that the required high levels of quality can be delivered. Clear channels of communication must be established for stakeholders, project managers, and translators. The review and feedback processes must be documented.
• It must have an established system of managing the many language versions, so that changes or updates in the future can be quickly implemented across languages.

Lexcelera has built a strong reputation over the years for its innovation in translation technologies and its extensive range of multilingual services. In February 2021, Lexcelera was acquired by the t’works Group, a specialized translation services provider, though it continues to operate independently under its own brand and management.

Lexcelera offers a comprehensive suite of language solutions tailored to meet the needs of the medical equipment industry. A pioneer in the use of cutting-edge translation technologies, Lexcelera has developed AI-based machine translation engines and other high-performance tools to enhance translation efficiency and accuracy.

In the previous blog post as well as this one, we have looked at the critical role that interpreters play in a nuclear industry audit. They must be selected carefully, ideally with the support of a translation and interpretation agency. The interpreters must themselves be highly qualified and prepare for the audit to enable its success.

All these steps go a long way in ensuring the success of the audit and maintaining public safety.