EU MDR: May 2020 Is Coming Right Up

The European Union published its new Medical Device Regulation (MDR) in May 2017, and is nearing the end of its three-year transition period ending on May 26, 2020. By that date, medical device companies need to comply with these new standards. The goal of the MDR is to improve the safety, reliability, quality and performance of medical devices. Historically, there has been limited oversight of medical devices and varying interpretations of related regulations, which has led to problems. The wide range of products defined as “medical devices” must now comply with much stricter standards, including but not limited to: new device identification tools to help trace medical devices sold in the EU; registration in new databases for clinical investigations along with product registration and tracking; stricter pre-market control of high-risk devices; re-assessment for compliance and certification; and compensation for damage caused by such devices. These new rules will make it so that medical devices produced in the EU take longer to get to market, and will put pressure on companies to adapt their procedures in order to comply.

Part of the challenge for companies will be to understand the large scope of what constitutes “medical devices” under the new MDR. “Medical devices” include and are not limited to:

  1. Equipment that uses magnetic or electrical currents for brain stimulation
  2. Products used to clean, disinfect and sterilize medical devices
  3. Equipment used for cosmetic procedures like breast implants and liposuction
  4. High-intensity radiation equipment used for tattoos and hair removal
  5. Contact lenses and other eye products
  6. Products and substances used for Botox injections
  7. Any device used for diagnosis, prevention or treatment of a disease

The large scope of products considered “medical devices” is only one of the challenges. Among the other challenges medical device companies face with the approach of the MDR is the need for medical device translation services. Whenever a medical device is sold in multiple markets in which different languages are spoken, companies are required to translate those devices into all necessary languages. This can be a long process considering that everything from instruction manuals, warranties, safety warnings, and device interface need to be translated. Companies will need to translate and re-translate many products to prepare for new MDR standards.

Despite the complexities involved with the EU MDR, it is a good step for the European medical device market because the EU has an aging population of around 500 million, and the need for high-quality reliable medical devices is more important now than ever. European medical device companies that are serious about improving the safety and health of product users should view the new MDR with a positive mindset.

How medical device companies can prepare for the EU MDR:

  1. Fully understand the MDR: The MDR is a complex set of regulations that encompasses a wide variety of “medical devices”, and companies must fully understand it in order to adapt properly.
  2. Understand the intended use of all of their products: With so many products falling into the “medical device” category, including medical software that didn’t exist in 1992 when the MDD (the MDR’s predecessor) came into law, companies need to be very careful when defining the intended use of each of their products.
  3. Get ISO certified: The EU MDR requires the implementation of a comprehensive Quality Management System (QMS). Most companies can meet this requirement simply by obtaining ISO 13485:2016 certification and conforming to the EN ISO 14971:2012 risk management standard.

With this in mind, it is also important that companies hire a professional translation company to perform medical translation services for its products. The EU is a large market with 23 official languages, and misunderstanding or misinterpretation of the instructions of a medical device could cause a life-threatening error. Almost all medical devices require some form of document translation services, and companies must consider this long before putting new products to market, and when making changes to products due to the new EU MDR.

EC Innovations’ medical device translation services are provided by a highly trained team of medical translators and editors with professional degrees such as MD and PhD, in all major areas of the life sciences. For more than 22 years, our medical translation department has provided professional language solutions to many world-leading medical device manufacturers.

To date, ECI has achieved ISO 13485:2016, ISO 9001:2015, and ISO 1710:2015 certifications. We have 12 strategic offices around the world and operating divisions in Asia, Europe, and North America, offering full localization support into 130+ languages and 260 locales.

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