As soon as June 2021, manufacturers who do not comply with the new European Union Medical Device Regulation could have to pull their products off the market in all EU countries.
What is the MDR?
In basic terms, the MDR defines what regulations must be followed to sell a medical device in the European Union. Many of the regulations focus on quality assurance and medical device translation requirements. You can find the complete text on the EU website: “Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017”.
What you Need to Know
Last year, the European Union delayed the effective date of the new Medical Device Regulation due to the Covid-19 pandemic. The regulation is now set to take effect at the end of May 2021. The regulations will likely have significant impact on a large number of medical device manufacturers. Manufacturers who don’t comply could face their products being pulled off the market.
How Does MDR Impact Medical Device Translation Requirements?
This post will explore the key components of each article and annex related to medical device translation requirements and offer key recommendations to mitigate the impact of each regulation.
General Obligations of Manufacturers, Authorized Representative, and Technical Documentation
(Article 10, Article 11 and Annex II )
These sections outline the minimum requirements required to sell your medical device in the EU. They include providing any information and documentation that demonstrate the conformity of the device in an official union language. The device must also be accompanied by all appropriate instructions for use and packaging in the language of the country where the device is sold.
Importers, Distributors, and Private Labeling
If a distributor intends to private label, repackage a manufacturer’s product, or even modify and then resell a product, all restrictions of the MDR apply. This means a proper quality management system must be in place to ensure all business units comply with procedures for translation. If your distributor does not follow the regulations, you could be fined.
Key information that identifies the device and the manufacturer, the product’s lifetime, and any special steps or instructions for the healthcare professional and patient must be provided in the language of the member state where the device was sold.
EU Declaration of Conformity
(Article 19 )
The actual declaration of conformity must be translated into an official Union language. Fortunately, English is an official EU language, but in the interest of covering all articles related to translation, I didn’t want to leave Article 19 out.
Summary of Device Safety and Clinical Performance
(Article 32 & Article 41)
All device safety and clinical performance information must be written in a way that is clear to the intended user and be made public via Eudamed. This is where quality assurance is necessary to determine what is clear and what needs translation
Conformity Assessment Procedures and Analysis of Serious Incidents and Field Safety Corrective Actions
(Article 52 & Article 89)
These two articles call for the translation of any documentation in support of the conformity assessment procedures and also for the rapid translation to all intended users of a device after a (FSCA) Field Safety Corrective Action is taken.
Electronic System on Clinical Investigations
The EU and the member states will setup an electronic system that captures clinical investigations. Information submitted to the system must be submitted in the language of the member state involved in the investigation.
Translation Impact of the MDR On Manufacturers
So what does this all mean for manufacturers of medical devices looking to sell in Europe? In a recent webinar hosted by Joe Hage on the impact of the MDR the Quality Assurance expert and Founder of leanRAQA, Michelle Lott, mentioned that there is a lot of confusion among manufacturers about how to comply with the new regulations. COVID-19 and the delay of the regulations taking effect have added to the confusion.
Manufacturers should take steps to mitigate the risks of non-conformity of their products. Failing to comply with the new directive could lead to a company’s products being pulled off the market.
Translation Tips to Reduce the Impact of the MDR
Response Time and Translation
- Plan for rapid communication of corrective actions in multiple languages.
- Address response time on emergency projects with your vendor. Establishing some timelines before an urgent situation is important.
Translation Vendor Selection and Regulatory Compliance
- Vet prospective translation service providers for ISO registration. The vendor should also have a quality assurance platform that includes proper documentation and a corrective actions procedure.
- Review the translation vendor’s Quality Assurance Manual and ask for the key findings document from their last internal audit and ask about any corrective actions from previous audits.
- Beware of window dressing or a minimal effort regarding the translation vendor’s quality program and ISO related programs.
- Ensure your regulatory department uses an approved supplier list
- Ensure your vendor conforms to your SOP for translation
- Ask your vendor clearly spell out the steps in their process in their proposal or MSA (Master Service Agreement)?
- Require your translation vendor to have the ability to produce a full audit trail for every project. Most medical device manufacturers require some form of a compliance document that accompanies completed translation projects. The document should include an audit trail to the translators and editors involved with the project, document names, relevant project dates and a sworn statement of accuracy.
- Your translation vendor should also have experience in packaging translation and the ability to work in programs like InDesign and Illustrator along with an appropriate strategy for handling embedded text in graphics.
Addressing the Reading Level of Your Users in Translation
- Your translation vendor should have the ability to preserve the reading level (register) as written by the manufacturer. This is a new requirement in the MDR that states that each document must be written to maximize the level of understanding by the intended user.
- The translation company should provide a tracking system for project status, file retrieval, financial information and regulatory compliance documents.
Transparency in the Translation Process
- The translation method should be transparent. You are paying for the service so you should have a full understanding on the steps and tools used to provide the service, including what QA steps they follow.
- Look for a vendor with transparent pricing with cost savings and consistency boosting strategies that you can utilize.
- Seek consistency across platforms so that no matter what type of content or file types all of the content is stored in a translation memory database. This will help you maximize your investment in translation by increasing your ability to reuse existing translations.
- A part of translation success should be defined by translation memory utilization or the discounts generated through the reuse of previously translated content. Data like your total translation memory savings should be evident on every project and also reported periodically through the year. Having a complete understanding of the translation related regulations of the MDR will help you navigate the process and get your translated product to market faster.