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Medical device regulation: all you need to know

You were just FDA approved in the US and now want to sell your product in Europe, this means you will have to be MDR compliant starting May 2021.  Learning and keeping up with legislation can be a complicated process, but is important as it can affect your business. Not long ago, the EU passed a new regulation that will affect all stakeholders in the health sector, such as manufacturers, authorized representatives, notified bodies, and economic operators. Soon, all will have to comply with  this new regulation. The goal of this article is to introduce the changes created by the EU MDR (Medical Device Regulation) and present the first steps you should take to become compliant. If you are an American company and are already selling in the US, you will still have to adapt and be compliant with the EU MDR in order to sell your products in Europe. 

Questions you may ask yourself:

- In how many languages will I have to translate my content into?

- Will UDI compliance force the re-labeling of existing devices?

- How and when should I get ready for the MDR? Is there a delay for the MDR? 

Medical Device Regulation: Context

The European Union Medical Device Regulation 2017/45 , also called the EU MDR, was released by the European Parliament and the Council of the European Union in 2017. It stems from the Medical Device Directive (93/42/EEC of 14 June 1993), whose goal was to harmonize the laws related to medical regulations in the EU. The EU MDR will repeal and replace the Medical Device Directive (MDD) and will be effective on the 26th of May, 2021 (previously set for May, 2020 but delayed by the EU due to the COVID-19 pandemic). 

Although its overall purpose remains similar to the MDD it contains slight changes relating to device classification and device scope, as well as stricter oversight of manufacturers, new requirements for UDI marking of devices and packaging, Eudamed registration, and increased post-market surveillance. The changes in the scope and classification were done to adapt to new additional products, which were not previously covered by the MDD. It now includes, for example, a range of products without a medical purpose, such as contact lenses, equipment for liposuction, and tattoo removal lasers. 

Many companies are worried about the new regulation. For example, Jeffrey B Jump (chairman and CEO of MedAlliance) wrote in an article  in October of 2019 that “MDR could become the most disruptive factor to hit the European healthcare market since the start of the Second World War”. He thinks that more than 500,000 products will be affected by the MDR. Becoming compliant with the EU MDR has become a priority in the industry as it requires many companies to adapt complicated processes, as well as translate content for their products in up to 24 languages (the 24 official languages of the EU). This clearly does not happen overnight and should be started as soon as possible. 

Not only does the regulation mention that the language used on the product must be “comprehensive, concise, clear, relevant, and understandable to the subject or user” , it must also be translated in the 24 official languages of the EU (see list at the end). 

Translating products in Europe will no longer be an add-on cost but instead will become an essential component when launching new products in the European Union. Integrating MDR in the development and life cycle of medical devices, as well as finding partners to centralize content management, is highly recommended. 

Medical Device Labelling: What Process of Validation?

The new regulation allows for new ways to identify medical devices, using a UDI (Unique Device Identifier), which will facilitate the traceability of medical products in the EU. What is the UDI? It is a series of alphanumeric characters which allow the identification of medical devices on the EU market and is comprised of a UDI-PI (Production Identifier) and UDI-DI (Device Identifier). 

This will enable authorities to trace medical devices more easily and significantly enhance “the effectiveness of post-market safety-related activities for devices and allow for better monitoring by competent authorities” . It will also help reduce the amount of counterfeit medical devices and medical errors. More precisely, one can look at article 27 of MDR and article 24 of the IVDR to get more information on the new UDI system. All manufacturers will have to assign a UDI to their products and packaging and make sure that all of the information is submitted to the European database on medical devices (Eudamed). 

The next step in obtaining the MDR certification, marked by a “CE”, is to ensure that the device meets all of the regulatory requirements imposed by the EU for medical devices”. To get certified, companies need to put in place a QMS (Quality Management System). On top of that, companies will need to translate their device’s content into the 24 official languages of the EU before getting the CE Because this translation has to meet quality standards it is important to partner with a Language Service Provider who holds the ISO17100 certification, like Powerling, as it sets internationally recognized standards for processes and quality assurance. Because of this ISO17100 certification, translators and proof-readers are professional native speakers who are specialized in the medical sector.

What are the next deadlines for EU MDR 2017/745?

When should you adapt your product so that they are compliant with the Medical Device Regulation?

Like mentioned earlier in the article, the deadline of the EU MDR regulation was moved up one year because of the COVID-19 pandemic. The 1-year delay of the date of the application might be welcomed by multiple stakeholders, as the delay of the MDR will help these companies rather focus on the immediate delivery of vital medical devices to healthcare workers and patients. However, it is important to remember that this delay does not give much extra time, especially if companies are slowed down due to the economic and health situation. It is not the time to stop working on MDR due to its large potential impact on the medical device industry. The general application dates to keep in mind are the 26th of May 2021 for medical devices and the 26th of May 2022 for in Vitro diagnostic medical devices. More precisely, the final date for all MDD-certified devices is to be MDR compliant before May 25, 2024, as long as the MDD certificate is still valid. If it is a new device, it will need to be MDR compliant starting on the 26th of May 2021.  

The deadline is approaching quickly, so it is essential to work with people you trust and who will be able to respect deadlines. A translation project of this type can be complex, especially for medical devices and since many languages are involved. Starting late on this can seriously compromise the launch of a product, which can ultimately have financial consequences.

How can a partnership with a language service provider help you? 

Powerling works with more than 40 medical device suppliers for the technical translation of their content (packaging, information pamphlets, clinical trials, manuals, etc.). 

Language services providers, like Powerling, understand the new requirements and are be able to proactively support you in achieving timely compliance. With a current database of 3,000 technical medical words, we have a solid background in medical device translations and can help you address the challenges of IFUs and the new UDI labelling requirements. 

On top of that, our translators have in-depth industry knowledge of safety, user documentation, and the entire life sciences commercial supply chain. We also work with doctors and pharmacists who validate translations in some cases and we always keep your documents highly confidential.

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Here is the official list of the European Union 24 official languages: Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish.

NEWS : Powerling has recently acquired WCS group.

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