Since 1992, medical device manufacturers around the world have been obliged to provide a checklist named Medical Device Directive (MDD) along with their merchandise to be able to serve the European market, which corresponds to almost 35% of a $460 Billion worth global market. Primarily, implementation of software into medical devices brought the need for EU Medical Device Regulation (EU MDR) today. Basically medical device regulation (MDR) is the updated version of the old MDD regarding the needs of technology that we have today.
New EU Medical Device Regulation
What is EU MDR? In a nutshell MDD was merely a checklist that the medical device companies needed to go through to be compliant. However, MDR is not just a simple checklist, it is a regulation. Therefore, in the EU context, this regulation acts as a national law that applies to all EU countries. The importance of having a regulation in place instead of a directive is that it provides consistency. The new regulations for medical devices contain 123 articles divided into 10 chapters and 17 annexes and they are considerably more detailed compared to the old MDD. All medical devices that are placed on the European market after the 25th of May 2020 including contact lenses, any type of subcutaneous filling materials, radioactive tattoo, or hair removal devices have to complete transition processes by the each of these articles until the 26th of May 2020 (postponed to 2021).
MDD to MDR - What’s Changed?
When we compare the MDD to MDR changes, the new regulation is more focused on promoting life-cycle approach rather than pre-approvals stage of medical device manufacturing. The MDD was more or less a manual for CE marking while MDR is a new set of policies and procedures that puts more weight on the medical device firms for their products' life-cycle. EU medical device regulation changes are primarily aimed to protect the EU's 500 million aging population from the adverse effects of medical device malfunctions. The new MDR brings many new regulations for all EU members such as expanding the definition of medical device, requiring companies for a qualified and responsible person for compliance and updating their technical documentation, and implementing much more detailed mechanisms for tracking. If you want to see all new regulations in detail, click here. Please note that there are no grandfathering processes available for the existing devices in the market, which means all devices regardless of their approval status, they will have to be certified again.
What Action Do You Need to Take?
EU Medical Device Regulation entered into force in May of 2017. However, there has been a 3 year period to allow pharmaceutical and medical companies to certify their products under the new regulations. This MDD to MDR transition timeline allowed the companies to take their time and adjust their products to the new system. As of May 2020, it has become mandatory for all existing and new products in the market to be in compliance with the new EU Medical Device Regulation. Starting from 2025, products with MDD certification will no longer be able to be sold or distributed. Companies need to ensure that their range of devices complies with MDR before 2025. Under the new regulation, companies are now obliged to include a wider range of information in technical documents and the number of required reports has increased. As the Medical Device Regulation process is more extensive in terms of documentation, it is recommended to take action ahead of time.
Translation Process for EU MDR
The new EU MDR translation requirements will be effective in all 24 EU languages. Hence, if the languages in your current MDR translation is missing even one language from the 24, you will be required to complete the translation into all 24 to comply with the regulation.
CE mark medical device requirements have also been updated, especially on the translation requirement side. So, what is CE marking for medical devices and why do you need it? CE Mark is European Union’s obligatory conformity marking in order to regulate the products sold within the European Economic Area. It declares that your product complies with EU’s New Approach Directives. It is required to have CE marking for any merchandise sold in the region.
While translation of any kind of document was not required for CE marking in the past, medical device translation companies will now need to submit translations for documents such as Instructions for Use (IFU). It is also required to have a precise and clear translation in the product documentation.
Here at MotaWord, with the help of our translators who are experts in the medical field, we’ll be glad to help you with your medical device translation needs. To learn more about how MotaWord provides blazingly fast and extremely accurate translations in the medical field, shoot us an email or come chat with us through our 24/7 live chat.
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