The Ins and Outs of the MDR
There are over 500,000 types of medical devices and in vitro diagnostic medical devices on the EU market. Examples of medical devices range from contact lenses and pacemakers to x-ray machines. In vitro diagnostic medical devices include HIV blood tests, pregnancy tests and blood sugar monitoring systems. Due to new regulatory laws from the European Medicines Agency (EMA), medical device companies will start competing in a significantly different and more complicated European market.
The EU Parliament adopted the proposal for the Medical Device Regulation (MDR) last year, which will replace the current Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC). This set in motion a three-year countdown to the new rules’ full application in 2020.
These regulations on medical and in vitro diagnostic medical devices will help to ensure that all devices are safe and perform well. To address this, according to EMA, the new rules will “improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and state-of the-art technologies. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.”
The vote in 2017 to approve the new regulations brings several advancements for medical and in vitro devices, including:
- Improve the quality, safety and reliability of medical devices: The new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market. Controls will also be tightened on clinical trials as well as on the bodies that can approve the marketing of medical devices. The new rules will also cover certain, previously unregulated aesthetic products (e.g. colored contact lenses that do not correct vision). In addition, a new system for risk classification in line with international guidelines will apply to in-vitro diagnostic medical devices.
- Strengthen transparency of information for consumers: The new regulations will make sure that vital information is easy to find. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in the new European database of medical devices (EUDAMED).
- Enhance vigilance and market surveillance: Once devices are available for use on the market, manufacturers will be obliged to collect performance data and EU countries will coordinate more closely in the field of market surveillance.
The Impact of Language + Localization
The average cost to bring a medical device to market is estimated at $31 million. From increased competition to continued pressure to control costs, the stakes for a successful launch have never been higher. Failure to prepare for launch and commercialization can result in delays and suboptimal results.
Marketing a medical device globally is not as simple as translating content from one language to another. Behind every global brand, there’s a team of translators, interpreters, transcribers, testers, linguistic copywriters and subject matter experts making sure that each piece of content is relevant, culturally appropriate and localized for the target audience and market.
To allocate resources and budget, organizations and localization teams must build a business case for localization. Numerous countries allow Instructions for Use (IFUs) and labeling to be in English. Adds Xavier Peña, Quality Control at Welocalize Life Sciences,
“Doing so may save money but could have negative implications for risk and market acceptance. It is still too soon to determine how exactly these new regulations will impact language requirements, but as rigorousness and complexity increases, likely will the need for translation.”
More Information and Resources
- As mentioned previously, to allow manufacturers and authorities to adapt, the new rules will only apply after a transitional period (three years after the 2017 publication for the regulation on medical devices and five years after publication for the regulation on in vitro diagnostic medical devices). For companies marketing devices in the EU that wish to continue to do, read “6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation” at RAPS.org. Then, meet our team at RAPS Regulatory Convergence in October to find out more about our expertise in medical translation services.
- For the European Commission’s collection of resources about the new MDRs, including a fact sheet, FAQ, and an industry overview, visit the following links.
Contact Welocalize Life Sciences for information on how we can help medical device manufactures with translation of labels, CE Markings and IFUs.